Small Molecule Antidote to Snakebite

Ophirex seeks funding from the Wellcome Trust to cover a portion of costs associated with developing U.S. FDA approved and W.H.O pre-certified oral and IV broad-spectrum antidotes to snakebite. The program will advance affordable, time-of-bite, heat-stable, easy-to-use, broad-spectrum treatments for snakebite based upon Ophirex's privately developed toxin-targeting portfolio. This new treatment strategy will provide superior care, rescue life and limb, and be easily administered in any environment. Not only will this antidote be easily used in unsupported environments in an oral form, it will also be effective in an IV formulation when needed, such as in pediatric care, rapid infusion for rescue/emergency treatment, and traditional intensive care.

Key attributes of this First-In-Class antidote are:

1) Broad spectrum efficacy for first-line treatment of snakebite

2) Excellent safety profile

3) Ease of use, easily administered anywhere

4) shelf-stability in Zone IV conditions with at least one-year shelf life.

All tasks support submission for FDA licensure and file transfers to other regulatory authorities (such as WHO precertification).

Key goals include:

Goal 1: Complete GMP API manufacturing and begin stability testing of oral and IV formulations for use in clinical trials.

Goal 2: Support Clinical Trial for registration submission for FDA and WHO precertification.