Spruce Biosciences Announces Presentation of Positive Topline Data from Phase 2 Study of Tildacerfont (SPR001) in Congenital Adrenal Hyperplasia at the 2019 Annual Meeting of the Endocrine Society (ENDO)

Tildacerfont demonstrates potential to become the first approved therapy for congenital adrenal hyperplasia, a rare endocrine disorder.

SAN FRANCISCOMarch 8, 2019 /PRNewswire/ — Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that the abstract, titled “A Phase 2, Dose-Escalation, Safety and Efficacy Study of Tildacerfont (SPR001) for the Treatment of Patients with Classic Congenital Adrenal Hyperplasia,” has been selected for a late-breaking poster presentation at the 2019 Annual Meeting of the Endocrine Society (ENDO), the world’s largest event for endocrine science and medicine.

“We regularly hear from patients and physicians who are looking for new treatment options for CAH,” says Spruce CEO Alexis Howerton, Ph.D. “We are pleased to be in a position to share positive data from our Phase 2 program, which demonstrated that tildacerfont was well-tolerated and effective in reducing ACTH and adrenal steroids. We look forward to sharing the data in more detail at ENDO later this month.”

Dina Matos, Executive Director, CARES Foundation added: “There continues to be a critical need for a therapeutic to enhance quality of life for patients by improving hormone levels and reducing steroid use. We are pleased to support Spruce’s efforts as it swiftly advances its lead program.”

CAH is a rare endocrine disease of impaired cortisol synthesis coupled with adrenal androgen excess. Although CAH is a part of the nationwide newborn screening program, there are currently no FDA-approved therapies for CAH.

Details of Spruce’s ENDO presentation are below.

Abstract: 8030
Title: A Phase 2, Dose-Escalation, Safety and Efficacy Study of Tildacerfont (SPR001) for the Treatment of Patients with Classic Congenital Adrenal Hyperplasia
Presenter: Kyriakie Sarafoglou, M.D., Associate Professor, Department of Pediatrics, University of Minnesota 
Date and TimeSunday, March 24, 20191:00-3:00 p.m. ET
Location: Poster Board # SUN-LB064, ENDO Expo Hall, Ernest N. Morial Convention Center

About Spruce Biosciences

Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. Spruce’s lead program, tildacerfont (formerly SPR001), is an oral, non-steroidal small molecule with the potential to be the first FDA-approved therapy for CAH. For more information on Spruce Biosciences and its lead clinical program for CAH, please visit www.sprucebiosciences.com.

Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. We are leveraging our extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from these diseases. We are committed to transforming the quality of life for patients who have been underserved by scientific innovation.