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Phospholipase A2 Inhibitor

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

Phase 2

Waitlist Available

Led By Matthew Lewin, MD, PhD

Research Sponsored by Ophirex, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 3, and 7

Summary

This trial tests varespladib-methyl, a pill that helps treat snakebites by blocking a harmful enzyme in the venom. Varespladib, originally developed to inhibit human secreted phospholipases A2, has shown high potency in neutralizing snake venom PLA2 toxins and is being repurposed as a treatment for snakebites. It targets people bitten by venomous snakes, including both children and adults. The drug aims to improve current treatments, which have limitations like being specific to certain snake species and not always being readily available.

Eligible Conditions

Snake Bites

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 3, and 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 3, and 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, and 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the combined pulmonary, cardiovascular, hematologic, and nervous system subscores of the snakebite severity score (SSS)

Secondary study objectives

All-cause mortality

Area Under the Curve (AUC) of the Numeric Pain Rating Scale (NPRS)

Cardiovascular system

+15 more

Other study objectives

12-lead electrocardiogram (ECG)

Analgesic use

C-reactive protein (CRP) levels

+20 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Varespladib-methylExperimental Treatment2 Interventions

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.

Group II: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varespladib Methyl

2021

Completed Phase 2

~100

Standard of care (SOC)

2016

Completed Phase 3

~500