Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite (BRAVO)

• ClinicalTrials.gov Identifier: NCT04996264
• Recruitment Status: Recruiting
• First Posted: August 9, 2021
• Last Update Posted: January 23, 2023
• Sponsor: Ophirex, Inc.
• Collaborator: Premier Research Group plc
• Information provided by (Responsible Party): Ophirex, Inc.

Study Description

Brief Summary:

This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of varespladib-methyl, concurrently with standard of care (SOC), in subjects bitten by venomous snakes.

Condition or disease	Intervention/treatment	Phase
Snakebites; Envenoming; Envenoming, Snake; Envenomation, Snake	Drug: Varespladib Methyl; Drug: Placebo; Drug: Standard of care (SOC)	Phase 2

Detailed Description:

This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of varespladib-methyl, concurrently with SOC, in subjects bitten by venomous snakes.

Approximately 110 male and female eligible subjects will be enrolled and randomized to receive active varespladib-methyl or placebo (in addition to SOC) in a 1:1 ratio (approximately 36 per group). There will be no stratification by type of snakebite, though randomization will be stratified by age group (5 to 11 years, 12 to 17 years, and ≥ 18 years) and by the presence or absence of severe neurologic symptoms defined by yes/no neurologic system subscore of the snakebite severity score of ≥ 2.

Effective treatments for snakebite envenoming represents a deadly and unmet global medical need. While antivenoms comprise the SOC for treatment of snakebites, they suffer from several limitations including specificity of each antivenom for specific species of snake, limited access to antivenom in rural areas, practical storage requirements, and delays in administration. Treatment of snakebite envenoming with the small-molecule drug varespladib-methyl, which targets secreted phospholipase A₂ (sPLA₂) present in more than 95% of snake venoms, has the potential to overcome several limitations of serum-based antivenoms that underpin traditional SOC.

This study in the United States and India will provide coverage of a broad spectrum of venomous snake genera, including elapids, pit vipers, and potentially exotics such as vipers and colubrids if encountered over the course of the study. The study is designed to cover differing geographies and differing sPLA₂ structures. Study sites have been and will be selected based on demonstrated historical incidence of snake bites from species deemed relevant to this study, to ensure a broad range of envenoming toxins are expected to be encountered in potential study subjects.

The study design allows for both treatment arms (varespladib-methyl and placebo) to receive SOC (e.g., antivenom) concurrently. Thus, critically ill adult and pediatric subjects may receive emergency treatment in a timely manner while being evaluated for the potential clinical benefit associated with inhibition of venom sPLA₂ and inflammatory sPLA2s by varespladib-methyl.

Because subjects with severe snakebites are admitted to emergency departments, this study was designed to screen, enroll, and administer treatment in a single visit at the hospital upon admission. Because varespladib-methyl is administered orally, subjects who demonstrate substantial improvement and are eligible for discharge from the hospital may continue investigational product treatment in an outpatient setting.

Risks associated with the control (placebo) arm of this study include the same risks associated with SOC (antivenom).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: All subjects, Investigators, and study personnel involved in the conduct of the study, including data management, will be blinded to treatment assignment except for a specified unblinded statistician and programmer from the study contract research organization who will have access to the randomization code. The unblinded study personnel will not participate in study procedures or data analysis prior to unblinding of the study data to all study-related personnel upon database lock. If an interim analysis is conducted, then unblinded personnel who are not otherwise involved in the study will prepare the data for review.
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of a Multi-Dose Regimen of Oral Varespladib-Methyl in Subjects Bitten by Venomous Snakes
• Actual Study Start Date: August 15, 2021
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Varespladib-methyl; Varespladib-methyl is an immediate-release (IR), oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration. Scaled pediatric doses of varespladib-methyl are supplied as 50 mg IR capsules for oral administration. Adult subjects will receive an initial loading dose of 500 mg (2 × 250 mg oral tablet) varespladib-methyl upon randomization, followed by dosing with 250 mg varespladib-methyl (1 × 250 mg oral tablet) approximately 12 hours later, and subsequent twice daily (BID) dosing with 1 × 250 mg varespladib-methyl oral tablets for the remainder of the 7-day treatment period. Tablets may be administered via naso- or orogastric tubes in patients requiring mechanical ventilation. Pediatric subjects (5 to < 18 years) will be administered doses of varespladib-methyl determined by allometric scaling, provided as 50 mg capsules. Age-appropriate capsules may be administered via naso- or orogastric tubes in patients requiring mechanical ventilation.	Drug: Varespladib Methyl; Varespladib-methyl (LY333013) is an IR, oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration. Scaled pediatric doses of varespladib-methyl (LY333013) are supplied as 50 mg IR capsules for oral administration.; Other Name: LY333013; Drug: Standard of care (SOC); SOC (including antivenom) will continue to be administered throughout the subject's participation in the study according to the protocol and the judgment of the Investigator.
Placebo Comparator: Placebo; The oral placebo is supplied as a white film-coated oval tablet to match the appearance of the varespladib-methyl 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Placebo for scaled pediatric dosing is supplied as an immediate-release capsule to match the varespladib-methyl 50 mg capsule, and contains the excipients lactose monohydrate, microcrystalline cellulose, and magnesium stearate. The dosing of placebo will match that of varespladib-methyl.	Drug: Placebo; The oral placebo is supplied as a white film-coated oval tablet to match the appearance of the varespladib-methyl 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Placebo for scaled pediatric dosing is supplied as an IR capsule to match the varespladib-methyl 50 mg capsule, and contains the excipients lactose monohydrate, microcrystalline cellulose, and magnesium stearate.; Drug: Standard of care (SOC); SOC (including antivenom) will continue to be administered throughout the subject's participation in the study according to the protocol and the judgment of the Investigator.

Outcome Measures

Primary Outcome Measures :

1. Change in the combined pulmonary, cardiovascular, hematologic, and nervous system subscores of the snakebite severity score (SSS) [ Time Frame: Baseline to 6 and 9 hours after first dose ]

   Change from baseline (pre-dosing) to 6 and 9 hours after the first dose, in the combined pulmonary, cardiovascular, hematologic symptoms, and nervous system subscores of the SSS. The values from each of these 4 subscores will be totaled. The average of the 6- and 9-hour scores will be used as the post-treatment value.

   The SSS is a tool used to measure the severity of envenoming based on 6 body categories: local wound, pulmonary, cardiovascular, gastrointestinal (graded at levels from Grade 0 to Grade 3), hematological, and nervous system effects (graded at levels from Grade 0 to Grade 4). A higher score indicates worse symptoms.

Secondary Outcome Measures :

1. Area under the curve (AUC) of the pulmonary, cardiovascular, hematologic symptoms, renal, and nervous system sections of the SSS [ Time Frame: Baseline through Day 7 ]

   Absolute values and change from baseline (pre-dosing) through Day 7 in the AUC of the pulmonary, cardiovascular, hematologic symptoms, and nervous system sections of the SSS.

   The SSS is a tool used to measure the severity of envenoming based on 6 body categories: local wound, pulmonary, cardiovascular, gastrointestinal (graded at levels from Grade 0 to Grade 3), hematological, and nervous system effects (graded at levels from Grade 0 to Grade 4). A higher score indicates worse symptoms.

2. Complete SSS scores [ Time Frame: Baseline through Day 7 ]

   Absolute values and change from baseline (pre-dosing) through Day 7 in the complete SSS.

   The SSS is a tool used to measure the severity of envenoming based on 6 body categories: local wound, pulmonary, cardiovascular, gastrointestinal (graded at levels from Grade 0 to Grade 3), hematological, and nervous system effects (graded at levels from Grade 0 to Grade 4). A higher score indicates worse symptoms.

3. Percent of patients with hematological abnormalities [ Time Frame: Baseline through Day 7 ]
   The percent of patients who had an SSS hematology score ≥ 2 at baseline with coagulation abnormalities from baseline (pre-dosing) through Day 7.
4. Hemolysis markers: percent of patients for each visual hemolysis score level and abnormal lactate dehydrogenase (LDH) [ Time Frame: Baseline through Day 3 ]
   The percent of patients for each visual hemolysis score level and abnormal LDH from baseline (pre-dosing) through Day 3.
5. Hemolysis markers: quantitative hemolysis score occurrence [ Time Frame: Baseline through Day 3 ]
   The quantitative hemolysis score occurrence (yes/no) and occurrence of abnormal LDH values (yes/no) from baseline (pre-dosing) through Day 3.
6. Levels of myonecrosis marker, creatine kinase (CK) [ Time Frame: Baseline through Day 3 ]
   Absolute value and change from baseline in CK from baseline (pre-dosing) through Day 3. Only patients with ≥ 2× institutional reference range at Baseline and gross hemolysis at baseline will be included.
7. Total antivenom requirement [ Time Frame: Baseline through Day 28 ]
   Total amount of antivenom given from baseline (pre-dosing) through Day 28.
8. Patients requiring ventilatory support [ Time Frame: Baseline through Day 28 ]
   The percent of patients requiring ventilatory support from baseline (pre-dosing) through Day 28.
9. Total duration of ventilatory support [ Time Frame: Baseline through Day 28 ]
   Total duration (days) of ventilatory support from baseline (pre-dosing) through Day 28.
10. Total duration of Intensive Care Unit (ICU) stay [ Time Frame: Baseline through Day 28 ]
    Total duration (days) of ICU stay from baseline (pre-dosing) through Day 28.
11. Total duration of hospitalization [ Time Frame: Baseline through Day 28 ]
    Total duration (days) of hospitalization from baseline (pre-dosing) through Day 28. Only hospitalization from baseline through Day 28 will be included.
12. All-cause mortality [ Time Frame: Baseline through Day 60 ]
    The number of patients experiencing the event (death) and the number of patients censored from baseline (pre-dosing) through Day 60. The all-cause mortality will be censored at Day 60.
13. Clinical Global Impression - Improvement (CGI-I) and Patient Global Impression of Change (PGIC) responders [ Time Frame: Baseline through Day 7 ]

    The proportion of patients with a score on the CGI-I and PGIC of 1: very much improved, or 2: much improved from baseline (pre-dosing) through Day 7.

    The CGI-I and PGIC are 7-point scales depicting a clinician's/patient's rating of overall improvement, with scores ranging from 1 (very much improved) to 7 (very much worse).

14. Patient-Specific Functional Scale (PSFS) total score [ Time Frame: Day 1 through Day 28 ]
    Absolute values and change in the PSFS total score from Day 1 through Day 28. The PSFS is a 3-item instrument which assesses functional abilities. The total score ranges from 0 to 10 with a lower score indicating greater functional difficulties.
15. Numeric Pain Rating Scale (NPRS) score [ Time Frame: Baseline through Day 28 ]

    Absolute values and change from baseline (pre-dosing) through Day 28 in NPRS score in patients able to respond pre-dosing through Day 28.

    The NPRS is an 11-point scale for patient self-reporting of pain with scores ranging from 0 (no pain) to 10 (worst possible pain).

16. Kidney function markers: blood urea nitrogen (BUN) and creatinine [ Time Frame: Baseline through Day 28 ]
    Absolute values and changes from baseline (pre-dosing) through Day 28 in BUN and creatinine levels (mg/dL).
17. Snakebite severity score [ Time Frame: Baseline through day 3 ]
    SSS neurologic system subscore

Other Outcome Measures:

1. Snakebite severity score [ Time Frame: Baseline through Day 28 after first dose ]

   Absolute values and change from baseline (pre-dosing) through Day 28 in the SSS at 4, 6, and 9 hours, and on Days 2, 3, 7, 14, and 28 after the first dose of varespladib-methyl.

   The SSS is a tool used to measure the severity of envenoming based on 6 body categories: local wound, pulmonary, cardiovascular, gastrointestinal (graded at levels from Grade 0 to Grade 3), hematological, and nervous system effects (graded at levels from Grade 0 to Grade 4). A higher score indicates worse symptoms.

2. Grip strength [ Time Frame: Baseline through Day 28 ]
   Absolute values and change from baseline (pre-dosing) through Day 28 in grip strength. The grip strength assessment is an objective measurement of hand function. The patient is asked to grip a dynamometer and squeeze with maximal force. The measurement is repeated for a total of 3 trials and the greatest value is recorded.
3. Analgesic use [ Time Frame: Baseline through Day 28 ]
   The proportion of patients reporting any analgesic use from baseline (pre-dosing) through Day 28.
4. PGIC scores through Day 28 [ Time Frame: Baseline through Day 28 ]

   Absolute values and changes from baseline (pre-dosing) through Day 28 in PGIC scores.

   The PGIC is a 7-point scale depicting a patient's rating of overall improvement, with scores ranging from 1 (very much improved) to 7 (very much worse).

5. Kidney function markers: estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline through Day 28 ]
   Absolute values and changes from baseline (pre-dosing) through Day 28 in eGFR (mL/min).
6. Kidney function markers: urinalysis [ Time Frame: Baseline through Day 28 ]
   Number of patients with abnormal urinalysis results from baseline (pre-dosing) through Day 28.
7. Complete blood count (CBC) [ Time Frame: Baseline through Day 28 ]
   Percentage of patients with CBC laboratory values below, within, or above the normal range by visit and in relation to baseline.
8. Transfusion requirement [ Time Frame: Enrollment through Day 28 ]
   The percentage of patients with hemolysis at enrollment with a transfusion event from enrollment through Day 28.
9. C-reactive protein (CRP) levels [ Time Frame: Baseline through Day 14 ]
   Absolute values and changes from baseline (pre-dosing) through Day 14 in CRP.
10. D-dimer levels [ Time Frame: Baseline through Day 14 ]
    Number of patients with abnormal D-dimer levels from baseline (pre-dosing) through Day 14.
11. Levels of myonecrosis marker (CK) [ Time Frame: Baseline through Day 3 ]
    Absolute values and change from baseline in CK from baseline (pre-dosing) through Day 3 in patients presenting with and without tourniquets at enrollment. Only patients with ≥ 2× institutional reference range at Baseline and gross hemolysis at baseline will be included.
12. Secretory phospholipase A₂ (sPLA₂) activity in serum [ Time Frame: Days 1 to 7 ]
    Absolute value and change from baseline in sPLA₂ activity in serum from baseline (pre-dosing) through Day 7.
13. Pharmacokinetic (PK) parameters of varespladib-methyl in plasma: area under the curve [ Time Frame: Days 1, 3, and 7 ]
    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable plasma concentration (AUC0-t), and area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf). PK samples will be taken from a subset of adult and pediatric patients on Days 1 and 3, and from all patients on Day 7 at the following timepoints: Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 (pre-second dose) hours post-dose; Day 3: pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose; Day 7: pre-dose.
14. PK parameters of varespladib-methyl in plasma: maximum serum plasma concentration [ Time Frame: Days 1, 3, and 7 ]
    The rate of absorption using the maximum serum plasma concentration (Cmax). PK samples will be taken from a subset of adult and pediatric patients on Days 1 and 3, and from all patients on Day 7 at the following timepoints: Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 (pre-second dose) hours post-dose; Day 3: pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose; Day 7: pre-dose.
15. PK parameters of varespladib-methyl in plasma: time of Cmax (Tmax) [ Time Frame: Days 1, 3, and 7 ]
    Tmax, the time of Cmax. PK samples will be taken from a subset of adult and pediatric patients on Days 1 and 3, and from all patients on Day 7 at the following timepoints: Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 (pre-second dose) hours post-dose; Day 3: pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose; Day 7: pre-dose.
16. PK parameters of varespladib-methyl in plasma: apparent first order terminal elimination half-life (t1/2) [ Time Frame: Days 1, 3, and 7 ]
    The apparent first order terminal elimination half-life (t1/2). PK samples will be taken from a subset of adult and pediatric patients on Days 1 and 3, and from all patients on Day 7 at the following timepoints: Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 (pre-second dose) hours post-dose; Day 3: pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose; Day 7: pre-dose.
17. PK parameters of varespladib-methyl in plasma: apparent terminal phase rate constant (λz) [ Time Frame: Days 1, 3, and 7 ]
    The apparent terminal phase rate constant (λz). PK samples will be taken from a subset of adult and pediatric patients on Days 1 and 3, and from all patients on Day 7 at the following timepoints: Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 (pre-second dose) hours post-dose; Day 3: pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose; Day 7: pre-dose.
18. Incidence and severity of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation of Investigational Product (IP) [ Time Frame: After obtaining informed consent until 28 days after the last day of study participation ]
19. Number of reported treatment-emergent adverse events (TEAEs) [ Time Frame: Beginning of treatment until last Follow-Up Visit/Telephone call at Day 28 ]
20. Rates of reported TEAEs [ Time Frame: Beginning of treatment until last Follow-Up Visit at Day 28 ]
21. Number of patients with a treatment-related SAE [ Time Frame: Beginning of treatment until last Follow-Up Visit/Telephone call at Day 28 ]

    The Investigator will assess each AE's relationship to the IP and categorize as either:

    Likely related: a reasonable possibility exists of a relationship between the AE and IP.

    Unlikely related: no reasonable possibility exists of a relationship between the AE and IP.

22. Clinical laboratory evaluations [ Time Frame: Baseline through Day 28 ]
    Number of patients with clinically significant abnormal laboratory values for CBC, urinalysis, liver function tests, renal function tests (albumin, creatinine, blood urea nitrogen, and estimated glomerular filtration rate) from baseline (pre-dosing) through Day 28.
23. 12-lead electrocardiogram (ECG) [ Time Frame: Baseline through Day 28 ]
    The number of patients with normal and abnormal ECGs from baseline (pre-dosing) through Day 28.
24. Concomitant medications and analgesics [ Time Frame: Baseline through Day 28 ]
    The number of patients using concomitant medications and analgesics from baseline (pre-dosing) through Day 28.
25. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through Day 28 ]
    Absolute values and change from baseline (pre-dosing) or at the earliest time point clinically allowable (ideally Day 1) and then at every study visit through Day 28. The C-SSRS is a questionnaire used for assessment of suicidal ideation and behavior with the following scale: 0: no ideation present; 1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent; 6: preparatory acts or behavior; 7: aborted attempt; 8: interrupted attempt; 9: actual attempt (non-fatal); 10: completed suicide.
26. Snakebite Severity score [ Time Frame: Baseline through day 7 ]
    SSS neurologic system subscore Baseline through Day 7

Eligibility Criteria

• Ages Eligible for Study: 5 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Is a male or female subject ≥ 5 years of age with venomous snakebite and must present with an initial SSS of

   • 2 points in any SSS category other than gastrointestinal and 1 or more additional points in any other SSS category other than gastrointestinal or
   • ≥ 3 in any SSS category other than gastrointestinal.

   SSS scoring should be performed for inclusion assessment without waiting for receipt of Baseline hematological laboratory results. Gastrointestinal scores should not be used for inclusion.

2. Index event (snakebite) must be symptomatic and must have occurred within 10 hours of eligibility assessment.

3. Must meet one of two categories of inclusion criteria:

   Category 1: The patient has not yet completed first dose of antivenom:

   SSS inclusion score* of ≥2 in one system and ≥1 in another system (2+1) OR ≥3 in at least one system.

   OR

   Category 2: The patient has completed an initial dose of antivenom:

   SSS inclusion score* of ≥2 in one system and ≥1 in another system (2+1) OR ≥3 in at least one system AND CGI-I score of ≥5 (i.e., minimally worse, much worse, or very much worse).

4. Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.

Exclusion Criteria:

1. Has received antivenom treatment for envenoming prior to enrollment in this study.
2. Is considered by the investigator to have a clinically significant upper GI bleed evidenced by hematemesis, "coffee-ground" emesis or nasogastric aspirate, or hematochezia thought to originate from upper GI tract.
3. Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.
4. Has known history of inherited bleeding or coagulation disorder.
5. Is, at Screening Visit, using the following anticoagulants: warfarin/coumadin, argatroban, bivalirudin, lepirudin, apixaban, dabigatran, clopidogrel, prasugrel, ticlopidine or another anticoagulant agent not specifically listed, or has used heparin, enoxaparin, fondaparinux, or other low molecular weight heparin or antiarrhythmic drugs within 14 days prior to treatment.
6. Has a history of chronic liver disease such as chronic active viral hepatitis, alcohol-related liver disease, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, or autoimmune hepatitis.
7. Reports or has known pre-existing renal impairment or chronic kidney disease (defined as Stage 4 or receiving dialysis or hemofiltration).
8. Has a known allergy or significant adverse reaction to varespladib-methyl or related compounds.
9. Is considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns.
10. Is pregnant, has a positive serum human chorionic gonadotropin (hCG) pregnancy test or not willing to use a highly effective method of contraception for 14 days after initial treatment, or is breast-feeding.

Contacts and Locations

Contacts

Contact: Brandi Ritter, MPAS; 5302184454; brandi@ophirex.com

Locations

United States, Arizona

University of Arizona; Recruiting

Tucson, Arizona, United States, 85724

Contact: Beth Salvagio Campbell bsalvag@arizona.edu

Principal Investigator: Jared Mosier, MD

United States, California

Loma Linda University Medical Center; Recruiting

Loma Linda, California, United States, 92354

Contact: Tammy Phan thphan@llu.edu

Principal Investigator: Brian Wolk, MD

United States, Florida

University of Florida Health; Recruiting

Jacksonville, Florida, United States, 32209

Contact: Morgan Henson morgan.henson@jax.ufl.edu

Principal Investigator: Sophia Sheikh, MD

United States, Georgia

Agusta University Medical Center; Recruiting

Augusta, Georgia, United States, 30912

Contact: Houlton Boomer hboomer@agusta.edu

Principal Investigator: Richard Schwartz, MD

United States, Kentucky

University of Kentucky Chandler Medical Center; Recruiting

Lexington, Kentucky, United States, 40536

Contact: Ronda Petrey ronda.petrey@uky.edu

Principal Investigator: Peter Akpunonu, MD

United States, Louisiana

LSU LA Poison Control Center; Recruiting

Shreveport, Louisiana, United States, 71103

Contact: Lisa Caskey elizabeth.caskey@lsuhs.edu

Principal Investigator: Thomas Arnold, MD

United States, Mississippi

University of Mississippi Medical Center - Jackson; Recruiting

Jackson, Mississippi, United States, 39216

Contact: Simon Barinas sbarinas@umc.edu

Principal Investigator: David Vearrier, MD

United States, North Carolina

Duke University Hospital Durham, NC; Recruiting

Durham, North Carolina, United States, 27710

Contact: Madison Frazier madison.frazier@duke.edu

Principal Investigator: Charles Gerardo, MD

India

Government medical College; Recruiting

Kozhikode, Calicut, India

Contact: Neeraj Manikath, MD

Father Muller medical College Hospital; Recruiting

Mangalore, Karnataka, India, 575002

Contact: Tushar Gopal Krishna

Principal Investigator: Tushar Gopal Krishna, MD

K R Hospital Mysore medical College and Research Institute; Recruiting

Mysore, Karnataka, India

Contact: Suneetha DK, MD

Jubilee Mission Medical College and Research Institute; Recruiting

Thrissur, Kerala, India

Contact: Francy Louis, MD

Jawaharlal Institute of Postgraduate Medical Education & Research; Recruiting

Pondicherry, Puducherry, India

Contact: Chanaveerappa Bammigatti, MD

S.P. Medical College Snakebite Research Cell; Recruiting

Bikaner, Rajasthan, India

Contact: Surendra Kumar, MD

Calcutta National Medical College; Recruiting

Kolkata, West Bengal, India

Contact: Partha Pratim Mukherjee, MD

Postgraduate Institute of Medical Education and Research; Recruiting

Chandigarh, India

Contact: Ashish Bhalla, MD

Sponsors and Collaborators

Ophirex, Inc.

Premier Research Group plc

Investigators

• Principal Investigator: Matthew Lewin, MD, PhD; Ophirex, Inc.
• Principal Investigator: Timothy F Platts-Mills, MD, MSc; Ophirex, Inc.

More Information

Additional Information:

Drug Development and Drug Interactions | Table of Substrates, Inhibitors and Inducers 

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• Responsible Party: Ophirex, Inc.
• ClinicalTrials.gov Identifier: NCT04996264
• Other Study ID Numbers: OPX-PR-01
• First Posted: August 9, 2021
• Last Update Posted: January 23, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ophirex, Inc.:

envenoming; venom; snakebite; snakebite severity score; varespladib; snake; antidote; LY333013; sPLA2

Additional relevant MeSH terms:

Snake Bites; Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Varespladib methyl; Phospholipase A2 Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action