Business
Relmada Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2020 Financial Results
Phase 3 Program for REL-1017 as Adjunctive Treatment for Major Depressive Disorder Initiated Multiple Data Readouts Anticipated Over Next Several Quarters
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"Phase 3 Program for REL-1017 as Adjunctive Treatment for Major Depressive Disorder Initiated\n Multiple Data Readouts Anticipated Over Next Several Quarters\n Company to Host Conference Call and Webcast Today at 4:30 PM ET\n\n\nNEW YORK, March 23, 2021 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced financial results for the fourth quarter and full-year ended December 31, 2020. \n\n \n \n \n \n \n \n\n \n\"We have achieved significant progress in advancing our lead product candidate, REL-1017, which has the potential to be the first U.S. Food and Drug Administration (FDA)-approved anti-depressant for adjunctive treatment of major depressive disorder (MDD),\" said Dr. Sergio Traversa, Relmada's Chief Executive Officer. \"In our successfully completed Phase 2 study, REL-1017 demonstrated statistically significant, rapid and sustained anti-depressant effects with a favorable safety and tolerability profile. Based on these compelling data and our interactions with the FDA and scientific advisors, late in 2020, we were thrilled to initiate our Phase 3 program for REL-1017. Our first of two Phase 3 trials, RELIANCE I, is enrolling as planned, and we expect to begin the second study, RELIANCE II, imminently.\"\n\"Looking ahead, we anticipate multiple key data readouts over the next several quarters, including data from our oxycodone human abuse potential study in the second quarter of this year, followed by data from our IV ketamine human abuse potential study by year-end 2021. Further out, we look to top-line data from both RELIANCE I and RELIANCE II in the first half of 2022,\" continued Dr. Traversa. \"Importantly, we have a strong balance sheet driving our robust development efforts, with a cash runway that is anticipated to support us through multiple potentially value-creating catalysts.\"\nRecent Corporate Highlights\nInitiated Phase 3 program for REL-1017 for the adjunctive treatment of MDD in December 2020 Phase 3 program will consist of two sister, two-arm, placebo-controlled clinical trials to be conducted at 55 clinical sites in the U.S. and include approximately 364 MDD patients in each study Dosed first patient in first pivotal Phase 3 trial, RELIANCE IAppointed Paolo Manfr...