Axsome Therapeutics week seven (full week) of Auvelity prescription data for MDD, came in > than 1000, reported by IQVIA. The 1000 for week seven was a 30% increase from week six's 770, released on 12/2/22. The impressive weekly data so far looks like this below.
Week 7 12/09/22 = 1000
Week 6 12/02/22 = 770
Week 5 11/25/22 = 510
Week 4 11/18/22 = 582
Week 3 11/11/22 = 360
Week 2 11/04/22 = 308
Week 1 10/28/22 = 158
Again, courtesy of research analyst Mizohu, is Auvelity compared to other recent Major Depression drug launches. The table is somewhat hard to read, the week 4 change in total prescriptions (TRx's via IQVIA) is 17% w/w change (308 to 360), which is impressive. We will keep tracking Auvelity's launch, but for right now, it's very positive. Again, thanks to Mizuho for the market research. Please click on the table below, for better viewing.
When looking at the launch of Axsome's Auvelity for MDD, it is important to note the week 1 to week 2 change of prescriptions percentage. This could give us a general indication of trajectory of public uptake. From below, and courtesy of research analyst Mizohu, is Auvelity compared to other recent Major Depression drug launches. The table is somewhat hard to read, the week 2 change from week 1 in total prescriptions (TRx's via IQVIA) is 394% w/w change (32 to 158), which is impressive. We will keep tracking Auvelity's launch, but for right now, it's very positive. Again, thanks to Mizuho for the market research. Please click on the table below, for better viewing.
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.
Today Axsome Therapeutics announced the FDA has approved their drug, AXS-05 for Major Depressive Disorder. The commercialized product (AXS-05) will be named Auvelity. This is a good day for patients suffering from MDD, as Auvelity is a new oral mechanism of action, which acts very quickly, and has shown durability in clinical trials, that led to the FDA approval. The company plans to start selling the product early in the fourth quarter. The press release is here Auvelity FDA Approval. The stock had a very strong day as expected, up +40%. Below is a daily chart of Axsome.
Three companies have released phase 3 clinical results with their respective drugs for Alopecia, and plan to file for FDA approval for this unmet need. Graph below of the clinical results, showing what each companies highest dose achieved in their phase 3.
The above chart shows, the effectiveness that each drug to the SALT 20 scoring criteria. A lower SALT from baseline signifies that there was more hair growth while on therapy. The highest percentage of test participants that achieved under or equal to the SALT 20 score, was Concert's CTP-543 12mg, with 38% and 41% of patients scoring under, in two phase 3 clinical trials. The hope is that those suffering from Alopecia will have a selection of at least two effective drugs for their disease. Thank you for reading.
Axsome's New Drug Application (NDA) for Major Depressive Disorder, has progressed to product labeling discussions with the FDA. This puts Axsome a step closer to potential FDA approval. The company released the following SEC document below.
On June 24, 2022, Axsome Therapeutics, Inc. (the “Company”) received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.
Axsome's stock had a good week based on the document that the company filed on June 24th, 2022. Weekly chart below, AXSM stock advancing 66.15% under heavy volume.
Yesterday the PTAB (Patent Trial and Appeal Board) ruled on a PGR (Post Grant Review) in favor of Concert Pharmaceuticals. The petitioner Incyte Corporation, has not demonstrated beyond a preponderance of the evidence that each challenged claims is unpatentable. Incyte Corporation could appeal to the Federal Court system, but that can take several years to play out, and may come to the same conclusion that the PTAB just did.
CTP-543's patent runs to 2037, so plenty years ahead, even considering that Concert does not plan to submit a New Drug Application to the FDA until the first half of 2023, with expected approval, either end of 2023, early 2024.
CTP-543 would be addressing the unmet need of Alopecia Areata, an autoimmune disorder that causes your hair to come out, and which there is not an FDA approved oral treatment available at this time. Phase 3 clinical trial Alopecia data from Concert is expected in the coming weeks. Concert's stock had a positive reaction to this news, chart below. Thank you for reading.
There's not an FDA approved drug, for unmet medical need Alopecia available for patients at this time. Both Lilly (Baricitinib) and Concert (CTP-543) have now released long-term (52 week) Alopecia efficacy data, using the SALT score of equal to, or less than a score of 20. Note, that a SALT score 0f zero is considered a full head of hair. So the lower the score the more hair growth has been achieved while on therapy. Below is a chart of the percentage of patients achieving the SALT score of equal to or below 20, in each Lilly and Concert's long-term clinical trials.
