Companies to Assess Ovarian Health Biotech Drug

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8 Aug. 2023. A women’s health biotechnology company is partnering with a Brazilian drug maker to evaluate a precision target and treatment for ovarian health disorders. The collaboration gives Celmatix Inc. in New York an option to license the therapy discovered by Aché Laboratórios in Guarulhos, Brazil, but no financial details of the agreement were disclosed.

Celmatix discovers and develops through preclinical stages treatments for ovarian health conditions that exhibit specific genomic properties. The company’s technology is based on research in reproductive health by its founder and CEO Priaye Yurttas Beim while a postdoctoral researcher at University of Cambridge in the U.K. Celmatix says it maintains women’s health databases on genomics, medical histories, and lifestyle. And, says the company, those data collections are annotated with new research findings analyzed by natural language processing and machine learning algorithms.

The lead program at Celmatix is a treatment candidate for polycystic ovary syndrome or PCOS, a disorder marked by excess androgens or male sex hormones and formation of cysts in the ovaries. PCOS often results in infertility, missed or irregular periods, excess body hair, weight gain, and thinning hair. Celmatix cites data showing PCOS is a leading cause of infertility affecting 15 percent of women in reproductive age, and can affect a range of other health conditions. PCOS treatments so far address symptoms, not the underlying causes.

Melatonin signaling outside the central nervous system

The Celmatix PCOS therapy candidate is designed to stimulate melatonin receptor proteins that bind to melatonin, a hormone produced by the pineal gland in the brain that regulates the body’s circadian rhythm. The company says its research indicates melatonin signaling also occurs outside the central nervous system or CNS, extending to peripheral tissue including the ovaries. Celmatix says its treatment candidate targets rare mutations in melatonin receptor genes in women associated with the disease, thus addressing its underlying causes. The company says its PCOS therapy is designed to activate only in ovarian tissue to minimize adverse effects, such as drowsiness.

“We know there is a compelling link,” says Beim in a Celmatix statement released through BusinessWire, “between melatonin signaling outside of the CNS and endocrine, metabolic, and reproductive traits in women with PCOS. However, melatonin and existing selective melatonin receptor agonists are not viable therapeutics for ovarian health conditions because they have potent CNS-activity that creates significant side effects, including nausea and drowsiness.”

Aché Laboratórios says it independently discovered a melatonin receptor agonist as a treatment candidate for PCOS. The agreement calls for Aché and Celmatix to jointly assess the Aché melatonin receptor agonist in preclinical animal tests. If the studies are successful, the companies will negotiate a separate license and development agreement. Aché says it adds new markets through licensing agreements outside Brazil, now reaching 17 countries.

“By focusing on melatonin receptor action outside of the CNS,” adds Beim, “through this joint development and licensing option agreement with Aché, we are one important step closer to being able to offer relief to the millions of women with a range of ovarian health conditions, including PCOS.”

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