Axsome Therapeutics - An update on Progress

This will be an important year for Axsome Therapeutics, as they transform from a pure drug development company, to a drug development plus commercialization company. Below are some projected timelines that the company is planning on achieving for the first half of 2021.

• AXS-05 for MDD, new drug application to be accepted by the FDA mid April.
• AXS-07 for acute migraine, new drug application to be filed in April.
• AXS-07 new drug application to be accepted by the FDA in June.
• AXS-12 starts Phase 3 for narcolepsy in the second quarter.

                         

The weekly chart above illustrates that axsm has been trading in a range for the past ten months. As it currently stands today, the stock is at the lower bounds of the range making it a lower risk entry, for those looking to invest in the company.                               

 

AXS-05 Phase 2 Results for TRD - COMET

Axsome Therapeutics released phase 2 results from the COMET Treatment Resistant Depression clinical trial this morning. TRD is defined as those who had ongoing symptoms of depression despite receiving two or more antidepressants during the current major depressive episode. The results were compelling in this open label clinical trial. Below is a recap of what was discovered in the phase 2 trial.

• Mean MADRS of -20.6 improvement from baseline at week 6
• Remission from depression occurred in 43.8% of patients at week 6
• Remission was 62.3% at 6 months and 72.7% at 12 months

The mean MADRS score was 33.1 at baseline, and the adverse event profile was similar to other AXS-05 clinical trials which included, dizziness, nausea, headache, dry mouth and decreased appetite. The New Drug Application for MDD is projected to be submitted to the FDA in January. Thank you for reading.                          

Axsome Therapeutics Second Quarter Update

Axsome released their second quarter results this morning, and an additional press release updating their depression clinical program here AXS-05 Depression Clinial Program. The company accomplished a significant amount of progress on all fronts. This post will focus on the companies lead drug AXS-05 for Treatment Resistant Depression or TRD. Summary below.

COMET TRD Trial - A phase 2 an open label sub-study evaluating the efficacy and safety in TRD patients. Approximately 70 patients will be enrolled. The trial endpoints will include the change from baseline in the Montgomery Asberg Depression Rating Scale or (MADRS) total score, clinical response and remission. Topline results from the COMET-TRD is expected in the fourth quarter of 2020.

MERIT Trial - A phase 2 double blind placebo controlled trial randomized withdrawal study in patients with TRD. Approximately 50 patients will be enrolled. The primary endpoint of the trial is the time to relapse of depressive symptoms. Topline first half 2021.                                           

Esketamine for Depression

This post will focus on Johnson & Johnson's NMDA intranasal Esketamine (form of Ketamine) for treatment resistant depression or (TRD), with rapid onset of effect. Esketamine has received breakthrough therapy designation (BTD) from the FDA in 2013 for treatment-resistant depression, and again in 2016 for major depressive disorder with imminent risk of suicide.  JNJ through Janssen has several Esketamine phase 3 clinical trials for TRD patients currently running. Results from a phase 2 clinical study for patients 20-64 years of age with treatment resistant depression, (lack of treatment with at least two different oral anti-depressants) released results.  The results by Janssen showed a statistically significant effect, with ascending dose-response relationship, and response was observed as quickly as two hours post dose.  The side effect profile is better explained here JAMA Psychiatry in etable 4 supplemental 1. A rundown of the side effect profile from that supplemental is below. 
                                                                56mg                     84mg
Dizziness                                                40%                         47%
Headache                                               15%                          18%
Dissociation                                           35%                         24%
Dysgeusia                                               15%                          29%
Nausea                                                    20%                         24%
Dissociative  Disorder                           5%                          24%               
Oral Hypoesthesia                               20%                          12%     

We'll have to see how the FDA addresses the side effect profile of the intranasal drug. Thank you for reading.
 

AXS-05 A Novel Mechanism of Action

Axsome Therapeutics (AXSM) is a company working to bring drugs into the clinic, and through FDA approval for the indications of pain, and CNS disorders.  We are focusing on their unique mechanism of action CNS drug, AXS-05 at this time.  AXS-05 combines dextromethorphan (DM), and bupropion (BP), and is targeting the indications below. 

• Treatment Resistant Depression Disorder:  phase 3 initiated NCT02741791.
• Agitation in Alzheimer's disease phase 2/3 planned end of 2016.

Quick Facts:
Share Out:  19M
Market Cap:  135M
Cash:  44M
Patent:  2034

Like other drug development companies, Axsome has identified Dextromethorphan as a potential treatment for CNS disorders, and is using bupropion as an inhibitor, with potential increased efficacy affect.  I  expect the company to raise cash soon through a secondary offering, to fund future clinical trials.  Thank you for reading.