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

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