Collaboration to study a novel mechanism of melatonin receptor action outside of the CNS for treating PCOS

Celmatix Inc., a leading women’s health biotech focused on ovarian biology, and Aché Laboratórios, a leading Brazilian pharmaceutical company, today announced a collaboration and license option agreement to jointly investigate a novel peripherally preferred melatonin receptor agonist, discovered by Aché, for Women's Health indications. Today’s news follows Celmatix’s April announcement of the second of its three internal drug programs, targeting melatonin receptors outside of the central nervous system (CNS) to address a critical gap in the market for effective first-line treatments for a range of women’s health indications, starting with polycystic ovary syndrome (PCOS).

Under the terms of the agreement Aché and Celmatix will collaborate to assess the potential of the drug candidate in well established in vivo models of PCOS. Following successful completion of these studies, the companies intend to enter into a separate license and development agreement.

“We are excited to join efforts with Celmatix to explore the role of melatonin receptors in the context of PCOS, as well as to investigate the potential of a novel peripherally preferred melatonin receptor agonist discovered at Aché in restoring ovary function in these patients,” said José Vicente Marino, CEO of Aché. “Aché’s expertise in the research, development, and commercialization of medicines, in conjunction with Celmatix’s cutting edge know-how in the identification and validation of drug targets in the Woman’s Health field, will synergize for advancing the knowledge about PCOS and developing new medicines for treating the disease.”

PCOS is known primarily for being one of the most common causes of female infertility, affecting around 15% of women of reproductive age. However, disrupted ovarian physiology in women experiencing PCOS has also been shown to impact endocrine, immune, metabolic, cardiovascular, and mental health functions. Despite the prevalence of PCOS, no drug has ever been developed specifically to treat it. The existing standard of care for PCOS focuses on symptom management, including birth control pills to regularize periods, metformin to address insulin resistance, statins to control high cholesterol, ovarian stimulation for ovulatory dysfunction, and cosmetic procedures to remove unwanted hair. The Celmatix program is aimed at restoring ovarian function in a way that addresses the root cause of all these symptoms.

Celmatix Founder and CEO, Dr. Piraye Yurttas Beim explained, “We are thrilled to be able to advance our PCOS Melatonin Program through our collaboration with Aché. We know there is a compelling link 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. By focusing on melatonin receptor action outside of the CNS, 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.”

About Aché Laboratórios Farmaceuticos S.A.

Aché is a 56-year-old Brazilian pharma company with a leading reputation in the prescription and specialty fields. The company is one of the largest pharmaceutical corporations in Brazil, with five industrial plants that manufacture solids, liquid, semi-solids, parenteral drugs, antibiotics, and contraceptives. Aché has approximately 5,000 employees and more than 300 branded products in its portfolio, distributed across several therapeutic areas, including Woman’s Health.

Aché has been considered the most innovative pharmaceutical company in Brazil in the past years, with nearly 350 employees dedicated to drug discovery, pharmaceutical sciences, preclinical and clinical development activities, as well as a business development team focused on partnering activities. The company has launched several innovative products and formed global partnerships in the last years with leading biotech and pharma companies to discover and develop new molecules for diseases with significant unmet needs.

About Celmatix

Celmatix Inc. is a preclinical-stage women’s health biotech focused uniquely on ovarian biology. With its growing pipeline of innovative drug programs including an AMHR2 agonist program focused on ovarian aging, novel melatonin agonist program for PCOS, oral FSH for infertility, and collaborations with industry leaders, Celmatix is addressing areas of high unmet need by developing the next generation of interventions and pioneering advancements in ovarian health. Celmatix’s proprietary multi-omic ovarian health platform, the world’s largest of its kind, is the foundation of the company’s novel pipeline of first-in-class therapies. For more information, visit the company’s website at www.celmatix.com

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