Sarepta issues statement on AVI-7537 anti-Ebola compound DoD funding freeze

Tony Plohoros, Principal at 6 Degrees, and a spokesperson for Cambridge, Massachusetts-based Sarepta Therapeutics, has provided Etopia News with a detailed and informative statement recounting the story of AVI-7537, a potential treatment for the Ebola virus.  Here’s what he had to say:

“Given the unpredictability of Ebola outbreaks and the associated obstacles in conducting clinical trials during an outbreak, especially in a foreign country, Sarepta’s Ebola compound, AVI-7537, has been developed according to the FDA’s Animal Rule, thus relying on an animal model to demonstrate efficacy. Significant efficacy has been demonstrated in five independent studies conducted in nonhuman primates (rhesus monkeys) challenged with lethal viral inoculums (approximately 1000 PFU/monkey) of Ebola virus (Zaire). Typical survival ranged from 60-80% versus 0% survival in untreated animals. 

“AVI-7537 has been shown to be safe and well tolerated in a completed Phase I single-ascending dose study.  In addition, since the company’s Ebola drug and Marburg drug share an identical backbone chemistry and preclinical, clinical, safety, toxicology, and pharmacokinetics indicate they behave similarly, Sarepta believes the Phase I multiple ascending dose study results for its Marburg drug candidate can be extrapolated to AVI-7537 to optimize the safe and efficacious dose and to better understand its expected outcomes with its use during an emergency. 

“In October 2012, DoD suspended development of AVI-7537 due to government funding constraints. Here’s a link to that announcement.

“Sarepta has been in contact with a number of government offices and with the WHO and has made clear that the company is committed to making the AVI-7537 it has on hand available to patients who might benefit from it as part of the U.S. government’s and any international efforts to respond to the outbreak.”