Filament Health Corp (NEO:FH, OTCQB:FLHLF) can now carry out research activities in the United States investigating the therapeutic potential of its botanical psilocybin drug candidate PEX010 for substance use disorders including opioid use disorder, enabled by the US Food and Drug Administration opening its Investigational New Drug (IND) application.
The Vancouver, British Columbia-based psychedelic drug developer announced on January 31, 2024, that the FDA had green-lit the IND application, allowing it to commence research activities in the US.
The approval comes after Filament had previously submitted its IND-opening protocol to Health Canada and received a no-objection status from the regulator.
The company is planning a pilot study to take place in Vancouver at the University of British Columbia using this protocol.
Filament CEO Ben Lightburn recently joined Proactive to discuss the IND opening milestone and the company’s next steps.
Proactive: The FDA has opened Filament’s IND application for substance abuse disorder, can you explain what that means?
BL: IND stands for Investigational New Drug application and it's what companies have to do in order to investigate new drugs in the United States under the auspices of the FDA. Recently, Filament submitted an IND application for substance use disorders in general to the FDA and we’re proud to announce that was accepted.
Under the IND opening protocol, the first study we plan to conduct is a pilot study in patients with opioid use disorder using PEX010, our botanical psilocybin drug candidate. This study is actually set to place here in Canada, in Vancouver at the University of British Columbia. But nonetheless, getting the FDA to review the study and provide their comments means that in the future when the whole development package is submitted to the FDA, the agency has given its blessing to the earlier clinical work.
How does PEX010 work? Is it a treatment for opioid addiction or a treatment in place of using opioids?
We intend to use PEX010 for the treatment of opioid use disorder as a first-line treatment rather than as an adjunct therapy to what is currently available. Opioid use disorder treatments are mostly substitution therapies where the illicit opioid is replaced with pharmaceutical-grade opioids that provide extended relief from cravings.
We think there is a reasonable chance that PEX010, which is a botanical drug extracted from magic mushrooms and standardized to contain 25 milligrams of psilocybin per dose, could be a tool that could enable patients to get off all opioids completely. We’ve carefully selected our patient population as those who are not currently undergoing a substitution therapy.
How long is this trial going to last?
The trial should take approximately six to eight months. It’s a pilot open-label study because of the specific patient population that we’ve selected. Hopefully, by the middle to the end of the year, we will see results and then plan for a larger trial in the future.
There is a clear opioid crisis here in Canada and also in the US. Do you think the FDA is going to respond more favorably to potential treatments than even five or 10 years ago?
One of the things the FDA does is publish regular guidance when it sees development in a certain area. What’s notable is that in the last five years, we’ve seen new guidance published for botanical drugs. That was published in 2018. We’ve seen new guidance published in opioid use disorder that was published in 2020. And, of course, we’ve seen draft guidance published for psychedelic drug development. Notably, our study leverages all three of those guidances.
So, the short answer to your question is yes. It’s well known that the toxic drug crisis is one of the biggest crises facing society today as North Americans perish from opioid overdoses and existing therapies are not very effective. They aren’t well adhered to and have drawbacks in terms of increased tolerance and the potential of overdoses if patients relapse.
At the end of the day, more treatments are needed and we believe very strongly that our botanical drugs may provide an important tool in the fight against the opioid crisis.
Quotes have been edited for clarity and style