Business
Spruce Biosciences Provides Clinical Program Updates and Outlines Anticipated Milestones for 2023
Topline Results from CAHmelia-203 in Adult Classic Congenital Adrenal Hyperplasia (CAH) Anticipated in 2H 2023 Amendment to Phase 2 CAHptain Clinical Trial
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nTopline Results from CAHmelia-203 in Adult Classic Congenital Adrenal Hyperplasia (CAH) Anticipated in 2H 2023\n\nAmendment to Phase 2 CAHptain Clinical Trial in Pediatric Classic CAH Enhances Study Design; Topline Data from Adolescents Anticipated in 2H 2023\n\nTopline Data in Phase 2 P.O.W.E.R. Study in Polycystic Ovary Syndrome Anticipated in 1H 2023\n\nEntered Exclusive Licensing Agreement with Kaken Pharmaceutical to Develop and Commercialize Tildacerfont for CAH in Japan\n\n SOUTH SAN FRANCISCO, Calif.--(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 provided an update on its clinical programs, anticipated upcoming milestones and strategic priorities for advancing tildacerfont in classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS).\n\n“As we enter 2023, we are pleased to have recently announced our strategic partnership with Kaken Pharmaceutical to develop and commercialize tildacerfont in Japan,” said Javier Szwarcberg, M.D., MPH, Chief Executive Officer of Spruce Biosciences. “2022 was a year of clinical execution across the board, which puts us in a strong position to report topline data for a number of our clinical programs this year, particularly our CAHmelia-203 study for adult classic CAH in the second half of 2023. We also continue to make progress in our Phase 2 P.O.W.E.R. study for the treatment of PCOS and anticipate reporting topline proof-of-concept data in the first half of 2023.”\n\nDr. Szwarcberg continued, “Children represent the greatest unmet medical need in classic CAH, with urgent necessity for androgen-lowering and glucocorticoid-sparing therapies to reduce the risk of premature puberty and adverse effects, both of which have the potential to be addressed by tildacerfont, if approved. To that end, we’ve identified opportunities to enhance our CAHptain pediatric classic CAH clinical trial, by lowering the minimum age requirement from 6 years to 2 years of age and increasing the study length from 2 weeks to 12 weeks, with an additional 2-year extension option. We expect these enhancements will expand the amount of informative data that can be generated from the program and increase attractivene...