Clementia bags $60M to push a repurposed Roche drug through Phase II

Canadian biotech Clementia Pharmaceuticals raised $60 million in mezzanine cash to help it fashion a once-failed Roche ($RHHBY) drug into a promising treatment for a rare disease.

VC giant New Enterprise Associates stepped in to lead the latest round, joined by new investors including UCB, RA Capital Management and Rock Springs Capital Management. OrbiMed, which led Clementia's $22.5 million Series A earlier this year, also pitched in.

With the cash, the Quebecois Clementia plans to push forward with palovarotene, a retinoic acid receptor gamma agonist in-licensed from Roche. The Swiss drugmaker developed palovarotene as a treatment for COPD but sidelined the project after testing it in more than 800 patients. Clementia, noting the drug's potential to block bone formation, then picked it up with ambitions in fibrodysplasia ossificans progressiva (FOP), a rare and disabling disease characterized by tissue swelling and abnormal bone growth.

Now the company is working through a Phase II trial with palovarotene, hoping to duplicate some preclinical results in which the drug halted new bone formation in mice. The biotech is recruiting 24 FOP patients to receive either one of three doses of palovarotene or placebo, testing how well the drug can prevent bone growth and over 6 weeks. Clementia is also running a natural history study on up to 50 FOP patients in hopes of better understanding how bone formation interacts with the disease's other symptoms.

The company expects to have final results from its Phase II study by the end of the year, according to ClinicalTrials.gov, planning to roll into Phase III thereafter if the results are positive.

"The Clementia team has identified a critical unmet need in FOP and is working quickly and efficiently to advance the palovarotene clinical program," NEA Partner David Mott said in a statement. "NEA and this entire syndicate look forward to contributing to the company's efforts to develop a much-needed treatment."

- read the statement (PDF)