Axsome Therapeutics - ADVANCE 2 and ACCORD 2 Clinical Trials

While the company is in the final stages of their Alzheimer's Disease Agitation clinical trials, ADVANCE 2 and ACCORD 2, a reminder of the results of already completed ADVANCE 1 and ACCORD 1 below. 

ADVANCE 1 Results:

• Reduction in the CMAI (primary endpoint) vs placebo p=o.010

ACCORD 1 Results: 

• Delayed time to relapse p=0.014
• Relapse prevention p=0.018

Both ADVANCE 1 and ACCORD 1 results bode well for the eminent release of the two follow on clinical trials ADVANCE 2 and ACCORD 2, expected in the second half of 2024. Both follow-on clinical trials will be using the same endpoint criteria as the previous. Thank you f0r reading.

Tracking Weekly Auvelity Prescriptions

Axsome Therapeutics lead drug Auvelity, recorded a new prescription high of 9,125 this past week. The FDA approved Auvelity for MDD late 2022, and commercial launch followed. Data reported from IQVIA. Weekly prescription chart below. Thank you for reading.

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. 

AXS-14 for Fibromyalgia

Axsome's vast pipeline includes AXS-14, (esreboxetine) a novel treatment for fibromyalgia. AXS-14 brings a new mechanism of action, a highly selective and potent norepinephrine reuptake inhibitor which was successful in phase 2 and 3 clinical trials. There are currently three FDA approved drugs to treat fibromyalgia. 

• Lyrica (2007
• Cymbalta (2008)
• Savella (2009)

Axsome currently has AXS-14 patent pending, Google Patent. If approved, the patent would expect to extend out to around 2042. Another smaller company Tonix is expected to apply for FDA approval for their fibromyalgia drug, TNX-102 SL, in the second half of 2024. Below is a chart of Axsome which has trended around the $75.00 level most of 2024. Thank you for reading.