‘It’s A Huge Medical Need’ – Dr Routledge on Small Pharma DMT Phase 1 Completion

There’s been a buzz with Small Pharma (TSXV: DMT.V OTC: DMTTF) who has just successfully completed their Phase 1 clinical trial of DMT in combination with supportive psychotherapy. We spoke with Dr. Carol Routledge last in August about Small Pharma’s plans to test DMT on major depressive disorder, among other indications, and we’re pleased to have her back with us to discuss the results of Phase 1 and the road ahead.

Here’s some highlights from the interview.

Phase 1 completion by Small Pharma is just the first part of a combined study

Dr. Routledge says that they actually initiated a combined Phase 1, Phase 2a study. The reason why is that with the two studies combined, once the data was obtained from Phase 1, they could roll over into Phase 2 immediately without further approval.

Phase 1’s component, she says, was to evaluate safety, tolerability, pharmacodynamic effects and the PK in healthy volunteers. Small Pharma included psychedelic naïve patients in the Phase 1 study because they expected a lot of patients in Phase 2 to be psychedelic naïve as well.

Small Pharma Phase 1 studies help building a dosing regimen

Dr. Routledge says that one of the biggest aims of Phase 1 for Small Pharma was to identify doses of DMT that would elicit a breakthrough psychedelic experience in all subjects that was safe and well-tolerated.

She believes they have done that. More importantly, she believes that Small Pharma now has proof that DMT is well tolerated and safe despite DMT being known to elicit more intense psychedelic experiences.

Small Pharma chose DMT for Phase 1 studies because of shorter duration

But why DMT instead of a better-known molecule like psilocybin? Dr. Routledge acknowledges that DMT is similar to psilocybin – both are psychedelics, and both have shown some proof of efficacy in potential treatment of neuropsychiatric indications. But Dr. Routledge says that DMT is a different molecule – a next-generation drug – and they’re different in receptor binding and psychedelic experiences.

With the duration of the psychedelic experience in DMT being approximately 20 to 25 minutes as opposed to the better part of a day, the similar mechanism of DMT offers a potential of more clinical flexibility.

Investors can likely safely extrapolate performance on DMT from psilocybin

Dr. Routledge says that despite being a slightly different molecule and a different receptor, mechanistically, they have the same sort of neurological impact in human trials. It wouldn’t be wrong, she says, to extrapolate some from the results of psilocybin trials. But she adds that there could be additional benefits to DMT.

Until Small Pharma and other companies complete trials on MDD and other indications, she says it may be that psilocybin is better equipped to treat some, and DMT others. Profiling treatments over a number of indications is required to understand both of the similarities and differences.

Also, the patient needs to be considered. “There’s a lot of different moving parts,” she says.