The hours we spent in studying EPM and sarcocystosis in horses enabled us to recognize a path to help patients with Amyotrophic Lateral Sclerosis (ALS). We worked diligently for four years and invented a compound that modulates the innate immune system in diseased patients. With help from WuXi AppTec we completed the pre-clinical data needed to submit our IND to FDA. This work was conducted during the pandemic! Amazingly, the WuXi team sequestered in their labs for some of the work, meals were delivered and progress was made. The next step is a Phase 1 clinical trial, giving the drug to clinically normal people, and then we move to those suffering from ALS. All the steps are ready to enroll the first human to get TVALA in the Phase 1 study. If all goes well, the first ALS patient will get the drug this year. Over the past 4 years we identified 8 disease processes we'd like to target with a drug—all at once. We believe our drug will impact 6 diseased paths, perhaps the most influential will be lipid metabolism. You can read about our work up to this point in The ALS Conundrum A Tragedy in Eight Acts available as an eBook on Amazon. Proceeds from each book are used for ALS research.
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