Crinetics gets European approval for acromegaly drug PALSONIFY

Crinetics Pharmaceuticals Inc. (NASDAQ: CRNX) announced that the European Commission approved PALSONIFY (paltusotine) for treating acromegaly in adults, marking the company's first regulatory approval outside the United States.

PALSONIFY is described as the first once-daily, oral therapy approved for acromegaly treatment in the European Union. The drug is a selectively-targeted somatostatin receptor type 2 nonpeptide agonist.

The approval covers all 27 European Union member states and three European Economic Area countries. Crinetics plans to begin commercialization in Germany and Austria first.

The European Commission's decision was based on data from two Phase 3 clinical trials called PATHFNDR-1 and PATHFNDR-2, which studied the drug in both treatment-naive and previously treated acromegaly patients. The trials showed that PALSONIFY maintained insulin-like growth factor-1 levels and reduced symptoms in patients.

In the clinical studies, the most frequently reported side effects included diarrhea, abdominal pain, nausea, and abdominal discomfort. No serious adverse events were reported during the randomized controlled portions of the trials.

PALSONIFY already has approval from the U.S. Food and Drug Administration for first-line treatment of adults with acromegaly who had inadequate response to surgery or for whom surgery is not an option. The drug also has orphan drug designation in both the EU and Japan.

Crinetics has partnerships for the drug's development in other markets. The company works with Sanwa Kagaku Kenkyusho Co., Ltd for Japan, where a new drug application was recently submitted. In Brazil, Crinetics submitted a marketing authorization application to the national health surveillance agency.

The company is also developing paltusotine for carcinoid syndrome associated with neuroendocrine tumors in Phase 3 trials.

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