Accelerator Life Science Partners launched a spinoff company to develop an investigational migraine drug for a variety of seizure disorders and landed a federal contract to explore its use as a medical countermeasure against the effects of nerve agents.
Proniras, based in Seattle, licensed the exclusive global rights to tezampanel (LY-293,558) from Eli Lilly & Co., which is helping to finance the effort alongside the funding arms of Johnson & Johnson and WuXi AppTec, with support from Alexandria Venture Investments, ARCH Venture Partners, Watson Fund and WRF Capital.
The five-year contract, funded by HHS’ Biomedical Advanced Research and Development Authority, is worth as much as $89.5 million. Payments are linked to milestones tied to preclinical studies, clinical development under the FDA’s Animal Rule—which allows Proniras to submit efficacy data from animal models instead of human studies—and the future manufacturing of tezampanel.
With a current headcount of three, Proniras plans to pursue a second financing round before adding more staff, according to a company spokesperson. The amount of raised venture capital was not disclosed.
The drug has already demonstrated preclinical efficacy in treating nerve agent-induced seizures, as well as in studies of rodents exposed to the chemical weapon soman, which is more toxic than sarin gas. In a statement (PDF), the company said it hopes to initiate human safety trials and apply for an orphan drug designation by 2020, and anticipates receiving approval by 2022.
Proniras is setting out with a development program that's farther along than that of the typical biopharma startup, Accelerator CEO Thong Le said in a separate statement (PDF). “As a result, we believe that Proniras has substantial near- and mid-term opportunities for value creation in an indication that has not seen significant innovation in many years.”
In addition, the company expects BARDA’s insight to help support the drug’s development in other therapeutic areas.
Accelerator will manage the company’s executive operations, while Proniras co-founder Christopher Toombs, Ph.D., will serve as chief scientific officer. Previously, Toombs held leadership positions at Faraday Pharmaceuticals, Cylerus, Ikaria and Amgen.
“As recent events have clearly demonstrated, the need for medical countermeasures that can effectively treat nerve agent exposure is sadly more than theoretical,” Toombs said.
The company hopes tezampanel could be superior to the current standard of care for many seizure disorders, benzodiazepines, through a distinct mechanism of action that blocks glutamate signaling. According to ClinicalTrials.gov, tezampanel was previously examined in about 300 patients with acute migraine, in a 2007 phase 2 study sponsored by TorreyPines Therapeutics.