Ipsen hits potential roadblock with palovarotene

Ipsen (OTCPK:IPSEY) has suspended dosing in its Phase 3 clinical trial, PVO-1A-301, evaluating palovarotene in patients with fibrodysplasia ossificans progressiva (FOP) as well as its Phase 2 extension studies, PVO-1A-202 and PVO-1A-204, after a futility analysis by the Independent Data Monitoring Committee (IDMC) showed that the late-stage study was unlikely to meet the primary endpoint.

Citing “signs of encouraging therapeutic activity” in preliminary post-hoc analyses of the 301 trial, the company will conduct further assessments of the dataset. The IDMC did not recommend terminating the study. It noted that the highly contrasting data precluded a confident conclusion about futility.

The FDA’s partial clinical hold for the pediatric population under the age of 14 for FOP and multiple osteochondromas instituted on December 4, 2019, remains in effect (suspended further enrollment).

Management will provide updated guidance next month with its earnings announcement.

Ipsen acquired the rights to palovarotene via its acquisition of Clementia Pharmaceuticals in April 2019.

https://seekingalpha.com/news/3534282-ipsen-hits-potential-roadblock-palovarotene