Pα+ Psychedelic Bulletin #172: Lykos Scales Back IIT Program, CEO Steps Down; Psyence Scoops Up Clairvoyant for Peanuts; Mindstate’s Moxy Enters Phase I

Lykos Scales Back Investigator-Initiated Trials Program, Refers Some Researchers to PharmAla

In the wake of FDA’s rejection of Lykos Therapeutics’ MDMA-assisted therapy for PTSD new drug application (NDA), many individuals and organisations associated with the company are trying to make sense of their professional futures—not least the 75% of the company’s staff who were laid off last month.

But beyond the company’s own staff and vendors, a whole host of researchers who collaborate with Lykos via its investigator-initiated trials (IITs) are left wondering whether it will continue to partner on such projects.

From a researcher’s perspective, conducting a Lykos-affiliated IIT can have several benefits, such as the provision of technical and regulatory support from the company as well as study drug supply. These are even more helpful in the case of MDMA, a scheduled substance and new molecular entity, in the eyes of the FDA.

Given its recent setbacks, Lykos is likely motivated to reign in its IIT program for several reasons, the most straightforward of which might be reducing expenditures and commanding exclusive focus on the resubmission of the PTSD NDA.

But the company, which is increasingly under the direction of Lykos-described ‘pharma veterans’, is likely also taking a page out of traditional pharma’s playbook. It’s unusual for a pre-approval company to have a sprawling IIT program like Lykos’, as such studies are generally used as a way to explore label expansion or implementation-related matters in the post-marketing context.

There’s also the fact that pharmaceutical companies have far less control over IITs than their own sponsored studies, as the investigators are the originators and sponsors of their studies. This can be a useful way of increasing public and provider trust in the pharmaceutical company’s therapy, which could be especially helpful given accusations of a pro-psychedelics milieu at MAPS and its pharma progeny, Lykos. However, IITs could also lead to the generation and publication of data that are not flattering for MDMA(-assisted therapy), which could make things even more challenging for the company.

It’s perhaps little surprise, then, that Psychedelic Alpha has learned that Lykos is no longer willing to support at least some of the IITs it had previously intended to, and has offered Canadian public company PharmAla the option to step in and fill the gap...