News and events
OCTOBER 6, 2025
On October 6, 2025, the Levomecor team, in collaboration with researchers from the Massachusetts General Hospital and other internationally renowned universities and institutions, presented the poster titled "Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: Findings From Two Early-Terminated Phase 3 Trials" at the 2025 World Congress of Psychiatry (view poster). While these two randomized controlled trials Phase 3 trials did not meet statistical significance for the primary endpoint at Day 28, Study REL-1017-302 and pooled results from studies REL-1017-302 and REL-1017-304 showed statistically significant Day-7 rapid antidepressant efficacy. Notably, despite loss of statistical significance after the Day-7 timepoint, patients in the REL-1017 arm continued to improve on MADRS scores at all subsequent timepoints, signaling that the Day-7 antidepressant effects were sustained in esmethadone responders. Both studies confirmed the favorable safety and tolerability seen in over 1000 subjects exposed to esmethadone in clinical trials, with no opioid-like or ketamine-like side effects and no signal for metabolic side effects. With the limitations of early study termination, Day-7 statistically significant antidepressant effects and favorable safety results support the development of esmethadone as a once-daily, oral, rapid-acting, safe and well-tolerated adjunctive antidepressant.
Source: Levomecor Inc. For all inquiries: administration@levomecor.com
AUGUST 1, 2025
On August 1, 2025 Levomecor Inc. entered an agreement with MGGM Therapeutics, a contract research organization. MGGM has been servicing the progress of the esmethadone platform for the past decade through a close collaboration with University of Padova (Italy), Universita` della Svizzera Italiana (CH), Evotec and Eurofins, among other institutions and research facilities. This agreement between Levomecor and MGG allows a seamless progress of Levomecor's development of esmethadone and its related Neuroplastogen™ platform.
Source: Levomecor Inc. For all inquiries: administration@levomecor.com
JULY 22, 2025
On July 22, 2025, Drs. Charles Inturrisi and Paolo Manfredi, granted Levomecor Inc. a perpetual, worldwide, exclusive license to the esmethadone program and to the related Neuroplastogen™ platform.
Source: Levomecor Inc. For all inquiries: administration@levomecor.com
JULY 7, 2025
On July 7, 2025, Relmada Therapeutics transferred to Drs. Charles Inturrisi and Paolo Manfredi all rights, titles, and interests in the esmethadone platform technology. Drs. Charles Inturrisi and Paolo Manfredi are the original co-inventors of the esmethadone platform technology.
Source: Levomecor Inc. For all inquiries: administration@levomecor.com
Forward-looking statements
Historical statements herein reflect published or presented data and or Levomecor Inc. documents, contracts and data. Statements not historical in nature are forward-looking statements and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on Levomecor current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the statements, including the potential for Levomecor’s product candidates to progress, including the potential for Phase 3 esmethadone data to continue to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for esmethadone or other Levomecor assets or that clinical results will be acceptable to the FDA, failure to secure adequate drug supply, and the other risk factors. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Levomecor undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered a complete list.