CRNX - Crinetics Presents New Data at ENDO 2024 that Increases Body of Evidence Positioning Once-Daily Oral Paltusotine as Potential First-Choice Treatment Option for Acromegaly | Benzinga
First Scientific Presentation of PATHFNDR-2 Acromegaly Safety and Efficacy Data Following Positive Topline Announcement, Showing Rapid and Sustained IGF-1 Responses in People Treated with Paltusotine
New PATHFNDR-1 Patient-Reported Outcomes Analysis Showed Paltusotine Lessened Day-to-Day Breakthrough Symptom Exacerbations versus Prior Treatment with Standard of Care Injections, as Assessed by Acromegaly Symptom Diary
Long-Term Data from Open-Label ACROBAT Advance Extension Study Demonstrated Durable Safety, IGF-1, and Symptom Control at Up to 42-Months of Paltusotine Treatment
Crinetics Expects to Complete NDA Submission for Paltusotine in 2H 2024
SAN DIEGO, June 03, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today presented findings from its clinical development program evaluating oral, once-daily investigational paltusotine in acromegaly. Data presented included results of the Phase 3 PATHFNDR-2 trial, a new analysis of patient reported outcome (PRO) data from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy and safety results at 42 months from the open-label ACROBAT Advance extension study. The data were presented today at the Endocrine Society's Annual Meeting (ENDO2024), with findings from PATHFNDR-1 published as a manuscript in The Journal of Clinical Endocrinology & Metabolism.
"The depth and breadth of our clinical development program for once-daily, oral paltusotine under investigation for the treatment of acromegaly is on display at ENDO 2024, demonstrating its rapid, durable effect on both biochemical and symptom control in these studies," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Notably, based on patient reported outcome data captured daily by the Acromegaly Symptom Diary, a new analysis from the PATHFNDR-1 trial showed that paltusotine was able to drive significant and important differences in the frequency of acromegaly breakthrough symptom exacerbations compared to prior treatment with standard of care medications. We look forward to submitting a New Drug Application in the second half of this year and potentially changing the acromegaly treatment paradigm."
Efficacy and Safety of Once-daily Oral Paltusotine in Medically Untreated Patients with Acromegaly: Results from the Phase 3, Randomized, Placebo-controlled PATHFNDR-2 Study (Abstract #MON-694):
PATHFNDR-2 was a randomized, double-blind, placebo-controlled trial with a 24-week treatment period, followed by an optional open-label extension study evaluating paltusotine in 111 participants with active acromegaly (IGF-1 > 1.1 ULN) who were not pharmacologically treated. Results demonstrated:
- The study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 (IGF-1) level ? 1.0 times the upper limit of normal (xULN) compared to those taking placebo (5%).
- This represents the second Phase 3 trial showing a significant difference in symptoms favoring paltusotine.
- Response to paltusotine was rapid, with the majority of the effect in IGF-1 reductions observed between weeks two and four, and sustained throughout treatment.
- Among those treated with paltusotine, a reduction in IGF-1 levels occurred in 92.6% of patients (n=50/54) by the end of treatment.
- Paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine. The frequency of participants with at least one treatment emergent adverse event (TEAE) was comparable in the paltusotine treatment arm and placebo arm.
- The most commonly reported TEAEs in paltusotine-treated participants included: diarrhea, headache, arthralgia and abdominal pain. The frequency of adverse events considered related to acromegaly was notably lower in paltusotine treated participants compared to placebo treated participants.
Use of the Acromegaly Symptom Diary (ASD) in a Phase 3, Placebo-Controlled Study of Once-Daily, Oral Paltusotine in Patients with Acromegaly Switched from Injected Octreotide or Lanreotide (Abstract #MON-156):
PATHFNDR-1 was a randomized, double-blind, placebo-controlled trial with a 36-week treatment period, followed by an optional open-label extension study evaluating paltusotine in participants with acromegaly switching from standard-of-care ...