Business
Spruce Biosciences Provides Clinical Program Updates and Outlook for 2022
Topline Data from CAHmelia-203 and CAHmelia-204 Anticipated in 2H 2023 and 2H 2024, Respectively Strategic Reprioritization Extends Anticipated Cash Runway
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nTopline Data from CAHmelia-203 and CAHmelia-204 Anticipated in 2H 2023 and 2H 2024, Respectively\n\nStrategic Reprioritization Extends Anticipated Cash Runway by 6 Months into Q2 2024\n\nCAHmelia Program in Adult Classic CAH to Significantly Expand Sites Globally, Planned Increase of Up to 50 New Sites\n\nCompany Implementing Protocol Amendments to Enhance Design of and Accelerate Patient Recruitment in CAHmelia-203 and CAHmelia-204 Trials\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 provided an update on its clinical programs, upcoming milestones and strategic priorities for enhancing the design of and accelerating patient recruitment into the CAHmelia studies, which are evaluating tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH).\n\n“Following a comprehensive assessment of the CAHmelia program, we’ve identified opportunities to accelerate patient recruitment and enhance the designs of the studies evaluating the potential of tildacerfont as a treatment for adult patients with classic CAH,” said Javier Szwarcberg, M.D., MPH, Chief Executive Officer of Spruce Biosciences. “By increasing the number of global trial sites and effecting protocol amendments, we will be well-positioned to meet our revised topline data milestones. In addition, we have reprioritized activities which has enabled us to extend our anticipated cash runway by approximately 6 months, taking us into Q2 2024. We look forward to building momentum in 2022 with this new focus, wherein we execute on our strategic business and clinical objectives.”\n\nAnticipated Milestones\n\n\nCompletion of enrollment from the Phase 2 proof of concept clinical trial in polycystic ovary syndrome (PCOS) by the end of 2022 and topline results by the first half of 2023\n\n\nTopline results from CAHmelia-203 in adult classic CAH patients with poor disease control by the second half of 2023\n\n\nTopline results from CAHmelia-204 in adult classic CAH patients with good disease control by the second half of 2024\n\n\nTildacerfont Program Updates\n\nLate-Stage CAHmelia Program in Adult Classic CAH\n\n\nStudy Site Global Expansion for CAHmelia Program to ...