Clementia Announces Updated Phase 2 Part B Data on Palovarotene for FOP

Clementia Pharmaceuticals (Nasdaq:CMTA), a clinical-stage biopharmaceutical company innovating treatments for people with ultra-rare bone disorders and other diseases, today announced updated data from the open label extension of its ongoing Phase 2 clinical trial of palovarotene in fibrodysplasia ossificans progressiva (FOP).

As quoted in the press release:

“These updated data continue to support the potential for palovarotene in FOP, an ultra-rare and devastating bone condition,” said Clarissa Desjardins, Ph.D., founder and chief executive officer of Clementia. “Twelve-week flare-up outcomes for patients treated with palovarotene in our Phase 2 trial indicate a consistent treatment effect of approximately 73 percent reduction in mean new bone growth, or heterotopic ossification, and palovarotene was generally tolerated in both adult and pediatric patients. However, we observed that nearly half of the patients in Part B had flare-ups that went untreated mainly due to the criteria for flare-up treatment specified in the Part B protocol. The flare-up treatment criteria in the MOVE Trial, on the other hand, are expected to result in more frequent use of flare-up up dosing in response to flare-up symptoms. First and second interim analyses from the MOVE Trial are expected to occur in the second and third quarters of 2019, respectively, and are designed to assess new HO in treated patients as compared to external natural history study controls. We look forward to those data readouts next year and anticipate that they’ll reflect the true potential of palovarotene in patients who urgently need a treatment option.”

Click here to read the full press release.