Relmada Therapeutics (RLMD) Provides Regulatory and Development Updates on Ongoing Late-Stage Clinical Program for REL-1017 for Treatment of Major Depressive Disorder
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Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided regulatory and development updates regarding its ongoing late-stage clinical program for REL-1017 in major depressive disorder (MDD).
RELIANCE III, the new ongoing monotherapy trial, aims to randomize 364 patients and it is expected to be completed in the second quarter of 2022.
In addition, in order to support potential regulatory submissions seeking approval for REL-1017 as monotherapy and adjunctive treatment, the FDA confirmed that, based on what is known at this time, Relmada will not be required to conduct a two-year carcinogenicity study of esmethadone (REL-1017), as sufficient pre-clinical safety data have been generated to date. The FDA also confirmed that Relmada does not need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the data provided so far and the data generated by the Phase 3 program will be adequate to evaluate the cardiac safety profile of REL-1017.
"We are pleased that the RELIANCE III monotherapy registrational Phase 3 trial is up and running," said Dr. Paolo Manfredi, CSO of Relmada Therapeutics. "We believe that this advancement is indicative of the significant potential of REL-1017 to treat MDD. Importantly, conducting RELIANCE III as a Phase 3 study may meaningfully reduce the time to potential approval for REL-1017 as MDD monotherapy. We are continuing to actively enroll patients into RELIANCE I and RELIANCE II, our MDD adjunctive treatment pivotal trials, as well as into the new RELIANCE III monotherapy study. Meanwhile, RELIANCE OLE, the open label extension safety study, which is enrolling patients from RELIANCE I, II AND III, as well as de novo patients, is progressing steadily."
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