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Persistence Pays Off For Chiasma And Its Oral Acromegaly Therapy

 
• By Alexandra Shimmings

Chiasma has bounced back from a 2016 CRL for Mycapssa with a new SPA-agreed Phase III trial meeting all its primary and secondary endpoints. The product is positioned to be the first oral treatment for acromegaly.

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If at first you don't succeed, try, try again • Source: Shutterstock

Waltham, MA-based Chiasma Inc. could finally be on the cusp of becoming a commercial company three years after a complete response letter from the US Food and Drug Administration scuppered its immediate chances of reaching the market with Mycapssa, an oral treatment for acromegaly.

A new Phase III trial, CHIASMA OPTIMAL, pursued under a special protocol assessment, has hit all of its endpoints, and the company’s share price on NASDAQ closed up by nearly 27% at $7.86 on 23 July, when the news was announced

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