Axsome and SAGE Therapeutics are in phase 3 development for two promising drugs that treat Major Depressive Disorder or MDD. Both companies have completed phase 2 clinical trials with very good results, and each have achieved the Breakthrough Therapy Designation (BTD) from the FDA. What's different from the current Selective Serotonin Reuptake Inhibitors or SSRI's, is that both AXS-05 and SAGE-217 are fast acting oral delivery drugs that show efficacy within days of treatment, compared to many weeks.
Let's see how AXS-05 and SAGE-217 compare in a side by side analysis of important facts to consider. From the file below, and from listening to company conference calls, both AXS-05 and SAGE-217 could get FDA approval and to commercialization around the same time in 2021. What stands out is that while SAGE Therapeutics currently sports an 8.49B market cap, Axsome Therapeutics just a 768M market cap. Thank you for reading.
| Drug |
AXS-05 |
SAGE-217 |
| Action |
NMDA |
GABA |
| phase 2 |
ph 2 compare |
ph 2 placebo |
| Remission wk 6 |
47% |
45% * |
| BTD |
√ |
√ |
| Pivotal |
√ |
√ |
| phase 3 MDD |
n= 300 |
n= 450 |
| Start |
6/1/2019 |
12/1/2018 |
| End Expected |
12/31/2019 |
12/31/2019 |
| Safety Data Ext |
n= 300 |
n= 600 |
| NDA Filing est |
6/1/2020 |
6/1/2020 |
| Approval est |
3/1/2021 |
3/1/2021 |
| Delivery-oral |
b.i.d. |
qd |
| Patent |
2034 |
2034 |
| Market Cap |
768M |
8.49B |
| *15 day dosing |
|
|
- Axsome Therapeutics met with the FDA and was given an expedited pathway of AXS-05 for Major Depressive Disorder or MDD. Under this new agreement, the company's phase 2 clinical trial known as Ascend for MDD was given pivotal status, and will only need one other pivotal phase 3 with efficacy, to file a New Drug Application (NDA).
- The company plans to enroll for a new phase 3 placebo clinical trial in the 2nd quarter of 2019, with an expected completion date by the end of 2019. The company plans on initiating this phase 3 with an increased number of clinical sites recruiting participants, which will allow for completion faster over the successfully completed phase 2 Ascend clinical trial for MDD.
- The timeline for filing an NDA would then be in the first half of 2020. If this timeline holds up, AXS-05 could potentially get to commercialization around the same time as Sage Therapeutics drug SAGE-217, which is also pursuing the same MDD indication.
AXS-05 was given Breakthrough Therapy Designation (BTD) from the FDA for Major Depressive Disorder, and the patent extends out to 2034. Thank you for reading.
