Proniras Awarded BARDA contract to develop nerve agent MCM

Proniras Corporation announced in April that it has been awarded a contract potentially worth $89.5 million from the U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to develop tezampanel as a medical countermeasure for the treatment of nerve agent-induced seizures that are not stopped by current medications. Tezampanel is a small molecule compound that previously had been evaluated in clinical trials as a potential therapy for acute migraine and other neurologic indications and has demonstrated an attractive safety and pharmacokinetic profile in more than 400 human subjects.

Proniras Corporation announced in April that it has been awarded a contract potentially worth $89.5 million from the U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to develop tezampanel as a medical countermeasure for the treatment of nerve agent-induced seizures that are not stopped by current medications. Tezampanel is a small molecule compound that previously had been evaluated in clinical trials as a potential therapy for acute migraine and other neurologic indications and has demonstrated an attractive safety and pharmacokinetic profile in more than 400 human subjects.

“As recent events have clearly demonstrated, the need for medical countermeasures that can effectively treat nerve agent exposure is sadly more than theoretical,” said Christopher Toombs, PhD, DABT, chief scientific officer at Proniras. “Tezampanel holds great potential as a solution to this serious challenge, having shown favorable safety and pharmacokinetic profiles in clinical trials for acute migraine and demonstrating efficacy in preclinical models of nerve agent-induced seizures. Proniras is pleased to have the opportunity to work with BARDA to improve our nation’s health and security preparedness.”

Under the terms of the contract, Proniras will be responsible for conducting preclinical studies, and the clinical development and manufacture of tezampanel. Payments totaling up to $89.5 million can be made upon attainment of pre-specified milestones over a five-year period. Given the inability to assess the safety and efficacy of tezampanel in humans with actual nerve agent exposure, tezampanel will be developed using the U.S. Food and Drug Administration’s (FDA) Animal Rule (21 CFR 314.600). Under this rule, the FDA can accept a New Drug Application for tezampanel based on efficacy data from a pivotal study in animal models of nerve agent-induced seizures and Phase 1 and 2 trials in human subjects with other relevant neurologic conditions, and adequate safety data from trials in healthy human volunteers.

Proniras expects to file an Investigational New Drug application with the FDA to initiate human trials as well as an application for an Orphan Drug designation in 2020 and anticipates receiving an NDA in 2022. The company may also evaluate continuing development of tezampanel in additional commercial indications following its approval as a medical countermeasure.

Tags: Security, Contract

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