Completed Heart, Stroke & Blood Cancer

An India-Focused Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Oral Varespladib-Methyl in Subjects Bitten by Venomous Snakes

Funder Wellcome Charity-funded
Recipient organisation Ophirex
Funding £3.8M
Period Nov 2021 — Oct 2023

In plain English

AI plain-English summary

A single oral pill could replace the need for intravenous antivenom after a snakebite. This Phase 2 trial in India tests whether varespladib-methyl, taken by mouth, can safely stop venom from destroying tissue when given alongside standard care. Current antivenoms must be injected, often require cold storage, and cost too much for many rural clinics. They also fail against certain snake species. This drug targets a venom enzyme called sPLA2, which is common across many snake families, making it a potential broad-spectrum treatment. The trial will enroll patients aged five and older across 4 to 8 Indian sites. If successful, this pill could be stockpiled in remote health posts, administered by a community health worker without refrigeration, and remain stable for at least a year. Manufacturing costs are expected to be low compared to biological antivenoms. The company plans to seek approval in India and the US, then file with regulators in Asia, sub-Saharan Africa, and the WHO. For the 5 million people bitten by snakes each year, a shelf-stable oral drug could mean the difference between keeping a limb and losing it.

View original technical description
Ophirex seeks funding from the Wellcome Trust to support an India-focused Phase 2 human trial to evaluate the safety, tolerability, and efficacy of oral varespladib-methyl with standard of care after venomous snakebite in subjects aged 5 years and older. Technical Goals: Goal 1. Qualify and on-board 4 – 8 trial sites in India. Goal 2. Complete trial start-up activities including trial database, training, DSMB, and project operations. Goal 3. Complete regulatory submission and approval from Drug Controller General-India (DGCI). Goal 4. Complete trial and Clinical Study Report The program will advance broad-spectrum treatments for snakebite based upon Ophirex’s privately developed toxin-targeting portfolio and provide affordable, superior care to rescue life and limb. All tasks are focused on supporting eventual New Drug Application submissions in India and, separately the US to enable file transfers to other regulatory authorities (such as individual countries in Asia and sub-Saharan Africa as well as via WHO precertification). Key attributes of this First-In-Class antidote are: 1) Broad spectrum sPLA2 inhibition for first-line treatment of snakebite 2) Excellent safety profile for population at risk 3) Ease of use and administered anywhere 4) Shelf-stability for at least one-year 5) Low cost of manufacture compared to biological products

View the original record at the funder ↗

Researchers

Matthew Lewin (EPMC Awardee)Rebecca Carter (EPMC Awardee)Stephen Samuel (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

ADDovenom: Novel Snakebite Therapy Platform of Unparalleled Efficacy, Safety and Affordability
ICF: Early-stage development of a rapid diagnostic test for corroborating envenomings by the Indian Russell's viper
Discovery and early translation of small molecule toxin inhibitors for use as broadly effective, inexpensive, oral, prehospital snakebite treatments
Developing the next generation of anti-venoms to improve management of cobra poisonings in low and middle incoming countries
Developing a cocktail of enzyme inhibitors to universally treat haemotoxicity caused by snakebite

Original classification

Discretionary Award - Snakebite

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.