Business
Spruce Biosciences Reports Second Quarter 2021 Financial Results and Provides Corporate Updates
Clearance of IND for Treatment of Polycystic Ovary Syndrome New Patent Broadens Tildacerfont Intellectual Property Estate in Congenital Adrenal Hyperplasia
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nClearance of IND for Treatment of Polycystic Ovary Syndrome\n\nNew Patent Broadens Tildacerfont Intellectual Property Estate in Congenital Adrenal Hyperplasia\n\nPublication of Tildacerfont Phase 2 Data in the Journal of Clinical Endocrinology and Metabolism\n\n SAN FRANCISCO--(BUSINESS WIRE)--\nSpruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.\n\n“As we continue to progress the execution of the CAHmelia clinical program in adults with classic congenital adrenal hyperplasia (CAH), we were also pleased with the FDA’s clearance of our investigational new drug (IND) application for polycystic ovary syndrome (PCOS). This milestone allows us to continue fulfilling our strategy of advancing tildacerfont as a potential treatment for patients with rare endocrine disorders with significant unmet medical need,” said Richard King, Chief Executive Officer of Spruce Biosciences. “We believe that tildacerfont may provide a therapeutic option to treat the underlying pathophysiology of disease through reduction of adrenocorticotropic hormone (ACTH) and therefore adrenal hyperandrogenism in this population. With no therapies currently approved in the U.S. to treat hyperandrogenism due to adrenal dysfunction in females with PCOS, the clearance of our IND brings us one step closer to developing a potential new treatment option for these patients.”\n\nCorporate & Pipeline Highlights in Q2 2021\n\n\nClearance of IND for Treatment of Polycystic Ovary Syndrome: During the second quarter, Spruce completed a meeting with and submitted an IND application to the FDA for the study of tildacerfont, a potent and highly selective, non-steroidal CRF1 receptor antagonist, in females with PCOS. PCOS is a hormonal disorder common among women of reproductive age and is characterized by an overproduction of androgens, which can result in irregular menses, infertility, hirsutism, male pattern baldness and acne. Adrenal androgen excess in PCOS may result from an enhanced adrenal responsivity to ACTH. With clearance of the IND, Spruce remains on track to initiate a Phase 2 proof of concept study later this y...