On January 25th, 2022 the Food and Drug Administration (FDA) cleared MindMed’s MM-120 Investigational New Drug (IND), an LSD-based drug directed at treating generalized anxiety disorder, the first of its kind in over 40 years. The company now moves into phase 2b, which will focus on dose optimization.
Phase 2 clinical studies involve researchers administering the drug to a group of patients with the condition or disease that the drug is modeled to treat. Generally, phase 2 studies involve only a few hundred patients, which is not enough to prove widespread efficacy but will move the trial process along if successful. In phase 2, researchers generally have a better idea of the dosage, safety and side effects for the trial. Phase 2 trials can last anywhere from several months to two years.
In an interview on July 5, 2022 CEO Robert Barrow expressed his hopes of moving quickly with the MM-120 trials because of the previous studies that were conducted with LSD back in the 1950s. He mentioned that LSD is the most studied psychedelic ever, with over 20 studies done on over 500 patients. Those clinical studies showed the promise of LSD’s effects on anxiety in patients. Barrow considers those studies a form of de-risking for the company, since there are results and data that MM-120’s data can build on. In the MM-120 studies, Barrow mentioned the positive results as “a rapid and sustained clinically significant, statistically significant reduction in anxiety that lasted out to at least 16 weeks post treatment”
He went on to say the effects lasted much longer than 16 weeks, but that 16 weeks was the entire length of the data recorded. These overwhelmingly positive results should help bolster MM-120’s case for approval as the drug approval process continues. This trial appeared to follow good clinical practices (GCP), which is essential for a trial occurring outside the US to be considered credible and acceptable to the FDA. The trial must also be reviewed by an independent ethics committee (IEC). If done so, the positive results will be added to MM-120’s resume and will be a persuasive factor to keep the drug approval process moving along quickly.
In the same interview Barrow spoke about the company’s phase 2b study and that they are actively recruiting patients for the first dosing of MM-120 in phase 2b trials. They hope to begin the trials in the coming weeks and months and plan on having a full read-out by the second half of 2023. Barrow expressed his and the team’s excitement for their hard work to begin paying off by conducting these commercially sponsored, high quality studies. They will produce real, valuable data and insight into the efficacy of MM-120, which, if all goes well, will propel them into their larger phase 3 trials.
Moving onto Phase 3 and beyond
Once the drug trials move onto Phase 3, they will involve a much larger group of patients to receive doses. With a larger sample size, researchers will be able to confirm effectiveness, monitor side-effects and compare it to common drug treatments already in the market more effectively. Phase 3 trials usually last anywhere from one year to up to four years.
If Phase 3 proves to be successful, the company will submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA for approval. In general, this is the final approval needed before a drug may become widely distributed to the public. Going from an Investigational New Drug (IND) to an NDA or BLA is a major step for any drug manufacturer. In MM-120’s case, this will allow MindMed to begin administering doses in therapeutic sessions to the wider American public.
Once approved, a trial moves onto the final phase, Phase 4: post-marketing studies. These studies are conducted after the treatment is approved by the FDA for use. Phase 4 studies provide post-approval information, including the treatment risks, benefits and best uses. Companies can continue monitoring patients in this phase and watch for any long-term effects. Nonetheless, this is the light at the end of the tunnel for a drug, but not the end of the correspondence with the FDA. Any advertising/promotional material is sent to and must be approved by the FDA before being used. There are also follow-up post-marketing submissions that need to be made to the FDA regularly to show the drug’s continued efficacy.
MM-120 still has quite a long road ahead of it until a final decision comes down from the FDA, yet this is what lies ahead for every drug looking for approval to go to market from the agency. Barrow and Dr. Miri Halperin Wernli, MindMed’s Executive, are enthusiastic about the road ahead to broad regulatory approval. In regards to their most recent study results Wernli said, “The statistically significant, strong and long-lasting reductions in STAI-G scores, combined with similarly rapid and sustained responses in all secondary endpoint measurements, are extremely encouraging. These results further support MindMed’s clinical development strategy.”
The continued good news from the company’s trials is certainly encouraging and builds excitement for the results from the trials MindMed is actively recruiting for. Although we won’t hear the results until the second half of 2023, the company continues to move in the right direction.
