Enrollment Completed in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly
Topline results for PATHFNDR-1 study expected in Q3 2023
Excerpt from the Press Release:
SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the completion of enrollment in the Phase 3 PATHFNDR-1 study. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of once-daily oral paltusotine in acromegaly patients. Topline results from the PATHFNDR-1 study are expected in the third quarter of 2023. The Phase 3 PATHFNDR-2 study’s enrollment is ongoing and topline results are expected in the fourth quarter of 2023. If successful, Crinetics plans to submit data from the two studies to regulatory authorities in support of applications seeking approval for the use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies.
“We would like to thank study participants and clinical research professionals for their interest and contributions to the PATHFNDR-1 study. Completing enrollment is an important step toward our goal of providing patients and physicians with a once-daily oral therapy that we believe offers consistent control of IGF-1 levels and alleviates acromegaly symptoms,” said Alan Krasner, M.D., Crinetics’ chief medical officer. “If successful, paltusotine represents a potential alternative to standard-of-care somatostatin receptor ligand depot injections, which are often painful and disruptive to the lives of patients, typically requiring regular visits to a health care provider’s office.”
Scott Struthers, Ph.D., founder and chief executive officer of Crinetics added, “The over-enrollment of the Phase 3 PATHFNDR-1 study exceeded our expectations and we are looking forward to the completion of both PATHFNDR studies in 2023. As we work to complete these studies, we are also taking steps to increase our commercial readiness to provide patients with broad access to paltusotine, if approved.”
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