Infinity craters after lead drug flunks PhII cancer study

Infinity Pharmaceuticals' ($INFI) lead therapy failed a critical mid-stage hurdle as investigators moved to shut down a study for pancreatic cancer after the treatment in combination with a common chemotherapy failed to outperform the placebo-chemo combo in improving the overall survival of the metastatic patients involved. Investors wasted no time in registering their distress at the news, cutting the value of Infinity's shares in half in a matter of minutes. By mid-day Infinity shares had regained some of their value, with the stock down about 40%. 

Investigators enrolled 122 patients in the Phase II trial, dividing them into two groups which were treated with saridegib (IPI-926) and gemcitabine or the placebo combo. But a preliminary analysis "showed a difference in survival favoring the placebo plus gemcitabine arm due to a higher rate of progressive disease in the saridegib plus gemcitabine arm."

The failure marks a significant setback for Infinity, a Cambridge, MA-based developer which has vowed to make itself into "one of the next great biotechs in the country," as CEO Adelene Perkins told FierceBiotech in a briefing earlier this week. Saridegib, a Hedgehog pathway inhibitor, has been one of its brightest hopes, with the potential to impact a variety of cancers.

"While the outcome of this study is disappointing, we continue to believe in the therapeutic potential of Hedgehog pathway inhibition. As the Hedgehog pathway plays distinctly different biological roles in myelofibrosis and chondrosarcoma, our Phase 2 trials in these disease settings are ongoing," said Julian Adams, Ph.D., the head of R&D at Infinity.

Perkins noted in their release that the company still has 6 clinical trials underway for three programs, giving it more opportunities to reach the goal line. "We remain committed to our vision of building a sustainable company that discovers, develops and delivers important new therapies to patients," she affirmed.

- here's the press release