San Diego, California-based Crinetics Pharmaceutical announced today that its novel investigational drug paltusotine maintained IGf-1 levels in patients who switched from monthly injectable medications, paving the way for an FDA new drug application in 2024. The topline analysis of the results shows 83% of participants maintained IGF-1 levels. The analysis also shows paltusotine was well tolerated and reported no severe adverse effects. You can read the company’s press release here.
From everywhere you look at it, this is potentially fantastic news for acromegaly patients.
“I’ve had the great pleasure of personally getting to know many members of the acromegaly patient community. It’s these people, and the many others I haven’t met, that I immediately thought of when I saw the data from this study. First, gratitude for so many taking time out of their daily life to participate in this study and help advance the state of medical knowledge for treating acromegaly. Second, urgency to submit these data to regulatory agencies to get their approval to make paltusotine available outside of clinical trials. My hope is that paltusotine will let people focus on living their life and their acromegaly medicine becomes just another tablet they take in the morning.” said Scott Struthers, Ph.D., Crinetics CEO.
“We designed paltusotine to be a best-in-class option for patients with acromegaly,” he said. “We could not be more excited by the results from PATHFNDR-1, which further reinforce our conviction that, if approved, paltusotine could address patients’ unmet need for a simple, oral therapy. These data showed that upon switching from injected standard of care, paltusotine provided reliable, durable control of their disease. We intend to seek regulatory approval as quickly as possible once we complete the PATHFNDR-2 study early next year.” he added.
A full analysis of the PATHFNDR-1 results is underway, which the company expects to present at upcoming scientific congresses. PATHFNDR-2, a Phase 3 study of oral paltusotine in participants with acromegaly who are treatment-naïve or not currently receiving medical therapy, is fully enrolled. Topline data are expected in the first quarter of 2024. Pending successful findings from the PATHFNDR-2 study, Crinetics plans to submit a new drug application to the U.S. Food and Drug Administration in 2024, seeking regulatory approval for all acromegaly patients who require pharmacotherapy, including newly diagnosed patients and those switching from other therapies.
We look forward to hearing from Dr. Struthers in our weekly Pituitary World News podcast next week, so stay tuned for that.
Paltusotine is the first oral, once-daily selectively-targeted somatostatin receptor type 2 (SST2) agonist currently in Phase 3 investigational studies. It was designed by the Crinetics discovery team to provide an efficacious and convenient once-daily option for people living with acromegaly and neuroendocrine tumors. In Phase 2 studies and the recently completed PATHFNDR-1 Phase 3 study, paltusotine maintained IGF-1 levels in acromegaly patients who switched from monthly injectable medications to paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.
Listen to this podcast series – The Journey to a New Drug”: Understanding Molecules and Receptors, to learn more.
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