Two clinical trials tied to insulin production are going in separate directions, with U.S. regulators lifting a clinical hold on one while placing the clamps on another.
Diamyd Medical and Crinetics Pharmaceuticals are the subjects of the two regulatory decisions announced Monday morning, with Diamyd getting the go-ahead after a 14-month partial pause while Crinetics’ ambitions have been put on ice.
Diamyd says the FDA has lifted the partial clinical hold on a phase 3 trial of its self-titled immunotherapy for the preservation of endogenous insulin production after initially being halted in September 2021. At the time, the FDA told the Swedish company that it didn't have sufficient information on questions concerning the antigen-specific immunotherapy.
Diamyd says it has since had “several interactions” with the agency to resolve lingering issues. The trial has already been underway in eight European countries, and the company says it will now work with investigators and review boards to try to include U.S. sites.
The removal of the hold comes almost two weeks after the FDA approved Provention Bio’s precision Type 1 diabetes treatment, which Diamyd Medical CEO Ulf Hannelius said in a release earlier in the month created “clarity” around the approval pathway for new treatments “and will set a reference for the field regarding pricing and reimbursement.” Hannelius also took an opportunity in that same statement to tout Diamyd’s treatment over Provention’s, saying that the latter is an immunosuppressive treatment that comes with “warnings and precautions” while Diamyd hasn't shown “any major safety signals.”
But as Diamyd received its long-awaited nod, Crinetics was told to take its foot off the gas. The company says that the FDA has yet to wave through a phase 2 trial of its treatment for the oversecretion of insulin. A reason for the delay has not been provided yet, but the company plans to ask for additional details.
The treatment at play, CRN04777, was previously tested in a phase 1 trial in Germany. Among 78 healthy adults included in the trial, the drug showed no serious adverse effects and there were no discontinuations.
Crinetics made news last year when it spun out its radiopharmaceuticals unit as a standalone entity, following in the footsteps of companies like Roivant Sciences. And, while a clinical hold is never ideal, the company’s current finances should cushion the blow, with nearly $370 million in cash and equivalents available.