Canadian biotech Tekmira Pharmaceuticals ($TKMR) is planning to resume its Phase I study of an investigational treatment for Ebola now that the FDA has waved off some lingering safety concerns.
The agency had effectively halted development of TKM-Ebola, an RNAi therapy, back in July over concerns that it might be unsafe for administration in healthy volunteers. The FDA loosened its hold on the drug in August to allow for dosing of patients with suspected or confirmed Ebola, but the treatment's broader Phase I program remained on ice.
Now, regulators have again modified their clinical hold to allow Tekmira to dose healthy volunteers with as much as 0.24 milligrams of TKM-Ebola per kilogram per day, and the company is planning to get its Phase I safety trial back up and running in the coming weeks. In the study, patients will get either TKM-Ebola or placebo for up to 7 days, and Tekmira expects to have safety data in hand in the second half of this year.
Tekmira's shares have soared and plummeted along with TKM-Ebola's up-and-down development over the past year, fueled by the now-subsided outbreak of the virus in West Africa. July's clinical hold sent the biotech down more than 20%, while the FDA's gradual thawing helped it ascend to an all-time high in October as investors rallied around the drug's potential. But the simultaneous improvement of conditions in Africa have dampened enthusiasm for Ebola treatments, and Friday's news sent the biotech's shares up just 2%.
Meanwhile, the waning numbers of Ebola cases are making it difficult for global outreach organizations and pharma organizations to complete trials for new treatments and vaccines for the virus. Companies including Johnson & Johnson ($JNJ), GlaxoSmithKline ($GSK) and Merck ($MRK) are working with health authorities to study potential cures in Africa, and declining rates of infection--while unquestionably good for the continent--are making enrollment difficult.
Tekmira is developing its Ebola treatment under a $140 million contract with the U.S. Department of Defense. Beyond TKM-Ebola, the company's pipeline is largely focused on hepatitis B, for which it has 8 candidates in various stages of early development. Tekmira's RNAi platform also includes potential treatments for cancer and metabolic disease.