My personal opinion, for what its worth is that I wouldn’t trust either Atai or Lykos as far as could throw them.
He has some pertinent points about Lykos and he’s much better educated on the subject .
I can’t fault a lot of what he says but remember he’s in the money and patents game too.
So essentially we are talking Pepsi, Coke… GOP, Democrats …..etc .
There’s negligable difference between the two parties, it’s all about money and power and with psychedelics and I’d humbly suggest that isn’t a good mix.
This is what he says via Linked In
Activists are not necessarily drug developers – my opinion on the FDA Advisory Committee hearing on MDMA |
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This week’s FDA Advisory Committee hearing and subsequent two votes AGAINST Lykos Therapeutics’ (formerly known as MAPS public benefit corporation) MDMA assisted therapy (MDMA-AT) for the treatment of PTSD has been a sobering day for everyone who believed that activists and non-profits could be (better) drug developers for late-stage clinical trials. This episode has demonstrated that they are not. While there have been positive examples of activists/non-profits who have developed groundbreaking drugs early-stage, they have seemingly only been successful when handing over to biotech or pharma companies to push them through the lates stages and commercialization. Yesterday’s negative outcome has obviously been disappointing for all of us, as we (still) believe MDMA (which is not itself a psychedelic in the core definition, more below) is a promising drug with tremendous therapeutic potential for patients with severe mental health issues. And to make it crystal clear: It isn’t MDMA itself that was rejected per se, but the specific, poor data set provided by Lykos Therapeutics; in my opinion, there is still a strong chance that MDMA, with a properly conducted clinical Phase 3 trial program that addresses those concerns of the FDA advisory committee, will get approved. I also want to emphasize that this is a non-binding vote from an FDA public advisory committee and not the FDA’s ultimate decision on Lykos’ NDA, which is expected by August 11. The FDA, which has historically appeared very supportive of exploring the therapeutic potential of psychedelics as evidenced by multiple Breakthrough Therapy Designations for psychedelic compounds over the last 10 years, has the prerogative to make an approval decision at odds to the advisory committee’s vote, though that is unusual. But again, even if the FDA follows yesterday’s recommendation, this is not a NO to MDMA for good, but just for this particular trial package and broader data set. The committee particularly cited discrepancies in clinical trial design and conduct, inadequate collection of safety and other relevant data, bias in the evaluation of patients, and cases of patient abuse during the trials. Or in short: The trials of MAPS/Lykos have been deemed chaotic, with nonstandard designs – particularly regarding therapy – and questionable execution. IMO their Phase 3 trials more closely resemble traditional phase 2a trials in terms of size and quality. New trials can overcome the shortcomings of this package and potentially result in ultimate approval. It is also worth highlighting here that the first “psychedelic drug”, Spravato by Johnson & Johnson, has already been approved a while ago, showcasing that the challenges MDMA and other psychedelics face can be successfully overcome. Spravato, which is an esketamine nasal spray, faced similar hurdles as MDMA such as successful blinding, abuse liability studies, and rigorous clinical trials. The approval of Spravato provides a clear blueprint for how MDMA and psychedelics can navigate the complex regulatory landscape if executed properly. Most importantly, imho, yesterday’s events underscore the importance of atai Life Sciences’ mission: Proving once and for all that with rigorous clinical trials, psychedelics and MDMA have a place in modern medicine and can support the many millions of people in need of better mental health treatments. atai can afford to conduct those large-scale clinical trials that address all the questions that the regulatory bodies such as the FDA want to see answered (see an overview here[1]) as a result of our diligent approach to building a strong patent portfolio, an approach for which MAPS and their supporters have criticized and ostracized us. This “traditional” approach enabled atai to raise hundreds of millions of dollars to hire an experienced team that is capable of designing and executing the required studies to optimize the chances for success. This week’s events also demonstrate the special responsibility placed on anyone working with psychedelics and MDMA. Given the vast anecdotal evidence – often first-hand positive experiences witnessed in patients seeking help in those substances – there is a risk of becoming overconfident, zealous, and self-righteous. The psychedelic drug development industry must acknowledge that a vast majority of people – including many researchers and people sitting on boards like yesterday’s AdCom meeting – have not tried those substances themselves or witnessed somebody who has been helped by them. We cannot sway them with stories or advocacy. The only way to convince them is with strong data – which has been the focus of atai’s approach from day one.
Here’s my opinion what this all means for atai and the psychedelic renaissance:
I am proud of atai and Compass and their role as the flag bearers for psychedelics, and (in atai’s case) now also for MDMA. I am aware of the huge responsibility now weighing on us, and I am confident atai and Compass will not disappoint.
[1] https://atai.life/programs/ [2] https://www.linkedin.com/ [5] https://christianangermayer. |
