Business
Spruce Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Recent Corporate Updates
Late-Stage CAHmelia Program in Adult Classic CAH Advancing with Majority of Study Sites Active CAHmelia Program Enhanced Following Discussions with FDA -
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nLate-Stage CAHmelia Program in Adult Classic CAH Advancing with Majority of Study Sites Active\n\nCAHmelia Program Enhanced Following Discussions with FDA - Primary Data Expected in 2022\n\nAmended Debt Facility with SVB Provides Access Up to Additional $25 Million in Non-Dilutive Financing\n\nNew Drug Application (NDA) Filing for Tildacerfont in Adult Classic CAH Targeted for 2023\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 fourth quarter and full year ended December 31, 2020 and provided a corporate update.\n\n“2020 was a transformative year for Spruce Biosciences, as we firmly established our company as an emerging leader in the development of groundbreaking therapies for rare endocrine disorders,” said Richard King, Chief Executive Officer, Spruce Biosciences. “The initiation of our CAHmelia program in adult classic congenital adrenal hyperplasia (CAH) moves us one step closer to changing the treatment paradigm for patients living with this chronic and potentially life-threatening disease. Following the completion of our upsized IPO in October 2020, we are also preparing to expand the utility of tildacerfont through studies in children with classic CAH and in women living with a rare form of polycystic ovary syndrome (PCOS), with Phase 2 programs in both indications on track to initiate in the second half of 2021. We also remain focused on clinical study execution: we have the majority of our CAHmelia study sites now active across 2 continents and are encouraged by the level of patient interest registered with our study investigators and at CAHstudy.com.”\n\nKing continued, “Following discussions with U.S. Food and Drug Administration, we have decided to increase the open label extension period for CAHmelia-203 by 18 weeks and for CAHmelia-204 by 24 weeks. In addition, we have increased the size of CAHmelia-204 from 60 patients to 90 patients. We believe that these changes will result in a more robust data package. With these program enhancements, together with the impact of the ongoing COVID-19 pandemic, we now expect primary data from CAHmelia-203 in the first half of 2022 and CAHmelia-...