Following Lykos Therapeutics’ receipt of a Complete Response Letter (CRL) from the FDA, which is effectively a rejection of its first shot at approval of MDMA-assisted therapy for PTSD, the company has been preparing to navigate the tricky path ahead.
While details on the contents of the CRL are slim, we do know the agency has requested an additional Phase 3 study to clarify both the safety and efficacy of the intervention. That’s a tall ask for the startup, which would need a substantial cash injection to rise to the challenge. It would also push approval back several years.
Like any bad trip, however, an experienced guide might be able to minimise challenges and develop a more constructive path forward.
Lykos is hoping that its own experienced guide comes in the form of ‘pharmaceutical industry veteran’ David Hough, who it has drafted in as “senior medical advisor”. The company has appointed Hough to “oversee the clinical development program and FDA engagement regarding the resubmission of midomafetamine.”
There’s little doubt that Hough is experienced, not least in his position as compound development team leader for Janssen’s esketamine nasal spray, Spravato. He also has hands-on experience with mental health, having practised as an Army psychiatrist.
In this exclusive interview, our Editor Josh Hardman sat down with Hough to discuss how his experience in developing Spravato to eventual approval might inform any future clinical development of MDMA, Hough’s thoughts about the FDA’s verdict and the AdComm that preceded it, what a future Phase 3 program might look like, and more.
While Hough was careful not to describe a future Phase 3 as a definite requirement from the agency (pending Lykos’ appeal), it does seem like the writing is on the wall… the question, as we see it, is not so much whether FDA will continue to demand it, but how Lykos might be able to fund and conduct it.
Hough was also careful not to discuss the specifics of what a future Phase 3 study might look like, presumably to avoid backing the company into a corner as it heads into discussions with the agency. Aside from seeking to protect its prospects of negotiating a less-intensive path to resubmission with the agency, the company is likely also aiming to protect its relationship with the FDA by engaging in confidence.
In this Interview:
Learning from Spravato
FDA’s Evolving Expectations
Sizing Up a Future Phase 3
Was the FDA Entirely Unfair?
When Might We Next Hear from Lykos?
AdComm Conduct
Hough’s Motivations
Phase 3 Study Design Considerations
The Role of Psychotherapy
Site Selection
Hough’s Role at Lykos
Closing Thoughts
To read this interview, please sign in to your Pα+ account…
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