Ipsen stock falls after Phase II FOP trial misses primary endpoint

Investing.com -- Ipsen (EPA:IPN) stock tumbled 2% on Friday after the biopharmaceutical company announced that its Phase II FALKON trial for fibrodysplasia ossificans progressiva (FOP) failed to meet its primary endpoint.

The Paris-based drugmaker said the pivotal trial did not reduce new heterotopic ossification in adults and children living with FOP compared to placebo, leading to the study’s closure.

The investigational treatment, fidrisertib, was generally well tolerated with no safety concerns reported.

"These results are disappointing for the FOP community and patients living with this devastating disease," said Christelle Huguet, EVP, Head of Research and Development at Ipsen. The company noted that despite the setback, data from the trial would contribute to ongoing research on FOP.

The FALKON trial was significant in scope, enrolling 113 patients globally and taking over five years to reach completion. FOP is an ultra-rare genetic condition that causes bone formation in soft tissues like muscles and tendons, eventually shortening life expectancy to a median of 56 years.

Fidrisertib was designed as an oral treatment targeting the ALK2 kinase, the underlying cause of FOP. The medication was administered as a capsule that could be sprinkled on food or dissolved in water.

The FALKON study was structured in three parts, with the primary endpoint measuring annualized change from baseline in heterotopic ossification volume.

Despite the negative outcome, Ipsen emphasized its continued commitment to advancing understanding of the disease, which affects approximately 900 diagnosed patients worldwide.

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