Crinetics and Sanwa Kagaku Kenkyusho Enter Licensing Agreement for Paltusotine in Japan

Crinetics Pharmaceuticals and Sanwa Kagaku Kenkyusho said that they have entered into a strategic partnership to exclusively develop and commercialize Crinetic’s experimental therapy for acromegaly and neuroendocrine tumors paltusotine in Japan.

Photo: Scott Struthers, founder and CEO of Crinetics

Under the terms of this agreement, Crinetics will receive $13 million upfront and will be eligible to receive milestone payments related to the achievement of certain development, regulatory and commercial goals. In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales.

Sanwa will have an exclusive right to develop and commercialize the product in Japan and will be responsible for leading the development and commercialization of paltusotine for acromegaly and neuroendocrine tumors in Japan. Sanwa will assume all costs associated with clinical trials and regulatory applications associated with these processes. Crinetics retains all rights to develop and commercialize paltusotine outside Japan.

Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. Excess growth hormone secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms and physical manifestations of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism.

Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50 percent of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.

Carcinoid syndrome is a group of symptoms that presents in some individuals with neuroendocrine tumors. Neuroendocrine tumors (NETs) are a rare, slow-growing type of cancer that arises most often in the digestive tract. Carcinoid syndrome is most common in patients with neuroendocrine tumors that develop in the lung and gastrointestinal tract and metastasize to the liver. In these cases, the liver is unable to filter the hormones secreted by these tumors, causing them to be circulated systemically and inducing the symptoms of carcinoid syndrome which commonly include diarrhea and flushing.

Paltusotine is a new class of oral, selective, nonpeptide, somatostatin receptor type 2 agonists designed for the treatment of acromegaly. Somatostatin is a neuropeptide hormone that broadly inhibits the secretion of other hormones, including growth hormone from the pituitary gland. This loss of homeostasis in the growth hormone axis results in excess tissue growth and other adverse effects throughout the body.

Crinetics is currently enrolling patients in its phase 3 PATHFNDR program, which is evaluating the safety and efficacy of once-daily oral paltusotine in a wide cross section of acromegaly patients in the United States and Europe. In Japan, Sanwa expects to initiate phase 1 development with paltusotine in 2022.

“In Sanwa, we met a company that shares our vision of developing, as the first indication for paltusotine, a once-daily oral therapy for acromegaly that will establish a new class of medicine to allow patients to live full lives free of the burden of painful monthly injections,” said Scott Struthers, founder and CEO of Crinetics. “With the promise of additional indications for NETs, we look forward to a long and productive relationship with our colleagues at Sanwa and are pleased to have the external validation that such a high-quality partnership provides.”

Author: Rare Daily Staff