FDA re­jects Cri­net­ic­s' cur­rent PhII de­sign for hy­per­in­sulin­ism drug

The FDA has put a stop to Cri­net­ics’ plans for a Phase II tri­al on its con­gen­i­tal hy­per­in­sulin­ism drug, the com­pa­ny an­nounced Mon­day morn­ing.

Last Tues­day, the FDA told the small mol­e­cule biotech over the phone that its pro­posed Phase II study was “not yet per­mit­ted to pro­ceed,” and that the agency would give an ex­pla­na­tion with­in the next 30 days.

The orig­i­nal Phase II plan was to study CRN04777, an oral so­mato­statin re­cep­tor type 5 (SST5) ag­o­nist, in chil­dren ages 3 months to 12 years. Cri­net­ics sub­mit­ted its IND for that study on Oct. 24. The com­pa­ny did not re­spond to a re­quest for com­ment in time for pub­li­ca­tion.

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