Relmada Therapeutics Update

We recently wrote about the company, here. Relmada Therapeutics High Risk with Potential Reward in June. Relmada Therapeutics stock has moved higher under heavy trading volume. The company had mentioned, the Data Monitoring Committee (DMC), would take an interim look at Reliance II after 75-80% of patients have enrolled into the study. Assuming that is the reason for the upward move in the stock, could be good news for the ongoing clinical trial for drug REL-1017 for adjunctive treatment of MDD. We'll have to wait until their quarterly conference call in August to see if that is the case. Below is a chart of the stock that has moved higher by 49% under heavy volume to a high of 4.47, and has settled at 4.16. 

Relmada Therapeutics - High Risk with Potential Reward

Relmada Therapeutics (RLMD) is in phase 3 clinical trials testing REL-1017, for the adjunctive treatment of MDD. Adjunctive treatment is used in addition to primary treatment to help it work better. Relmada's clinical trials can be viewed here Relmada Clinical Trials. The most important event from an investment point of view, is the release of top line data, for clinical trial RELIANCE II, estimated second half of 2024. 

Risk assessment for investment purposes, is extremely high. Relmada is currently a $3.00 stock, so a successful readout of RELIANCE II could propel the shares much higher. On the other hand, a failure to show efficacy, would result in the stock trading around $1.00 per share. 

REL-1017 is a NMDA receptor antagonist drug, in a similar category of already approved J&J's Spravato and Axsome Therapeutics Auvelity. So having this mechanism of action successfully approved, and on the market is a positive for REL-1017.  We currently hold shares in Axsome Therapeutics and Relmada Therapeutics. Chart of Relmada below, thank you for reading. 

Relmada Phase 3 MDD Results

Relmada Therapeutics (RLMD) has been working on a new MDD drug (major depressive disorder) known as REL-1017, an NMDA (NMDAR) channel blocker. The company released top-line results on Thursday October 13th. The top line results revealed that the drug showed to be effective (-14.9 reduction from baseline), but the placebo group also displayed a reduction in depressive symptoms (-13.9 from baseline) on the MADRS 10 Total Score. The .9 differential between the two groups at day 28 was deemed to be a clinical trial failure. 

The company did a secondary clinical trial analysis, and determined that when excluding clinical sites with implausibly high or low placebo responses (4-5 of the total sites), showed a meaningful difference between REL-1017 and placebo to the effect of 4.9 points on the MADRS 10 versus placebo p=0.05. 

Based on the results above, Relmada may have to run another phase 3 clinical trial for MDD to proceed to an NDA filing. The timeline to starting and completing would be around one year based on this just completed clinical trial, then filing an NDA would require additional time. Most likely to get REL-1017 approved for MDD, could take two years from the start of an additional clinical phase 3 MDD trial to FDA approval, if everything goes well. Note that Relmada does not have Breakthrough Therapy Designation (BTD) for REL-1017, MDD. 

Axsome Therapeutics Auvelity, was just granted FDA approval for MDD in August 2022, with a planned launch early 4th quarter 2022. Auvelity, provides a fast-acting oral anti depressant therapy. REL-1017 would have competed directly with Axsome's Auvelity, as both provide a fast acting response, which is an unmet need to current MDD drugs on the market. Axsome's stock had an upward response after the Relmada results were revealed, while Relmada chart below, sold off.