Clementia files for $115M IPO to fund late-phase trials of ex-Roche drug in ultrarare genetic bone diseases

Clementia files for $115M IPO to fund late-phase trials of ex-Roche drug in ultrarare genetic bone diseases

Clementia Pharmaceuticals has filed to raise $115 million in an IPO. The Canadian biotech wants the cash to bankroll late-phase trials of an oral retinoic acid receptor gamma agonist it licensed from Roche.

Montreal, Canada-based Clementia intends to use the IPO money to take the former Roche drug, palovarotene, through two phase 3 trials in fibrodysplasia ossificans progressiva (FOP). If the data are good, Clementia plans to file for approval and make palovarotene the go-to drug for the 800 people diagnosed with the ultrarare bone formation disease.

Картинки по запросу palovarotene structure
Patients with FOP suffer from pain, disability and early death as a result of bones forming in their muscles, tendons and ligaments. Clementia estimates FOP affects 9,000 people globally.

Funded by a $60 million mezzanine round led by New Enterprise Associates, Clementia has tested palovarotene in a 40-patient phase 2 trial. That study failed to deliver statistically significant results but nonetheless emboldened Clementia to move into phase 3. The decision was underpinned by data suggesting palovarotene cut formation of new extraskeletal bone by 50%. In patients who did grow new bone, the mean volumes were around 70% lower than in the placebo group.

On the strength of the data, Clementia plans to push palovarotene into phase 3 while also running earlier-stage trials in other indications. A phase 2/3 trial in another ultrarare genetic bone disease, multiple osteochondromas, is planned, as are phase 1 and 2 trials in dry eye disease.

Roche tested the drug in more than 800 people, only to sideline it after it failed to significantly affect lung density in patients with moderate-to-severe emphysema. Around the same time as the setback for Roche, external researchers showed that retinoic acid receptor gamma agonists including palovarotene inhibit the formation of bone in soft tissue in animals.

This led the team behind Clementia to search for a retinoic acid receptor gamma agonist and ultimately pick palovarotene as the most promising asset and license it from Roche in return for milestones. Funding rounds and clinical trials followed, leading Clementia to the point at which it needs to refuel before a final push intended to bring palovarotene to market.

Clementia has yet to disclose insider support for the IPO, but it arrives on Wall Street at a time when investors are more receptive to biotech listings. A recent uptick in IPO activity has seen Aileron Therapeutics, Dova Pharmaceuticals and Mersana Therapeutics all go public.

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July 7, 2017 / Pharma News