German biopharmaceutical group Agennix has suffered a huge setback after its experimental lung cancer drug failed to hit its targets in a late stage clinical trial, casting a shadow of doubt over its future.
The group's stuck plunged nearly 80% after it revealed that a Phase III trial assessing its key drug talactoferrin in patients with non-small cell lung cancer (NSCLC) did not meet its primary endpoint in demonstrating an overall survival benefit.
The FORTIS-M trial looked at the effect of talactoferrin plus best supportive care (BSC) compared with placebo and BSC in patients with Stage IIIb/IV NSCLC, whose disease had progressed following two or more prior treatment regimens.
However, results showed that median overall survival in the talactoferrin arm was just 7.5 months compared to 7.7 months for placebo, spelling the end for the development programme and even potentially the firm itself.
Agennix' chief medical officer Rajesh Malik said the firm is "extremely disappointed and surprised with [the] results, especially considering the earlier promising results we had seen in two randomized Phase II trials".
And with regard to the wider ramifications of its failure, Torsten Hombeck, the group's chief financial officer, said "immediate steps" were being taken "to conserve cash while we evaluate our business options," and that more details on corporate plans will be published "in the near future."
Commenting on the development, Close Brothers Seydler Research analyst Igor Kim reportedly said “the talactoferrin story is over,” and he suggested that Agennix should now merge with another company, according to Bloomberg Businessweek.