On Friday, in a somewhat ambiguous news release, Tekmira updated investors on the Phase II ebola study being run in Sierra Leone with its RNA interference (RNAi) drug TKM-Ebola-Guinea. The company stated that the study had “reached its predefined statistical endpoint” and that based on that endpoint “continuing enrollment was not likely to demonstrate an overall therapeutic benefit”.
Based on this information, the company announced that study enrollment has been stopped, and that full results would be reported shortly. The press release did not reference any data, or what the predefined statistical endpoint was that triggered the conclusion of enrollment, but investors were quick to interpret this as a setback for Tekmira’s ebola program, sending the company’s stock down over 10%.
It was just last summer when Tekmira, along with several other companies developing ebola therapeutics and vaccines, was catapulted into the spotlight due to the ebola epidemic in West Africa. Suddenly, a program that most investors had dismissed became very high profile. However, to Tekmira’s credit, the company never sensationalized their ebola program or its potential role in the management of the epidemic. In fact, the company likely found all the media and investor attention around ebola distracting, especially considering the company’s R&D focus was squarely on a different development stage drug, TKM-HBV, for the treatment of chronic hepatitis B (HBV) infection.
Tekmira’s transition from being a RNAi company into a HBV company began in 2013 and was consummated earlier this year through the merger with OnCore BioPharma, a U.S. based HBV-focused drug development company. So Friday’s news of an apparent setback in its RNAi-based ebola program, although disappointing, likely re-affirmed to Tekmira that it was right to focus on HBV.
The question now, is what will become of Tekmira’s ebola program? The answer will likely emerge in a few weeks once more data from the Sierra Leone study is reported. Perhaps the broader question is whether an ebola program even belongs in the new HBV-focused Tekmira. The discussion around whether Tekmira should sell or spin-out its non-HBV assets has been percolating ever since the OnCore merger, but recently gathered more attention after one of the analysts covering Tekmira put out a note highlighting the potential for the company to be split into two. This seems like a logical choice for Tekmira, and Friday’s news on its ebola program and the subsequent market reaction, likely galvanized their resolve to becoming a 100% focused on HBV.