MAPS revealed headline results from their successful Phase 3 trial of MDMA-assisted therapy for PTSD. The data reveal promising efficacy and safety profiles, which will be put to the test once more as MAPS undertakes a second Phase 3 study. The non-profit is on-track for a potential FDA approval in 2023.
The search for new indications to target with psychedelic medicines – a trend we have been highlighting for the past few months – presents itself again this week, epitomized by MindMed’s announcement of Project Angie. The program will initially target 2 pain indications: one severe, and one chronic. MindMed’s stock, now trading on Nasdaq, failed to react to the announcement.
Below, editor-at-large Graham Pechenik takes a look at Small Pharma’s first patent grant (forthcoming) and uses the opportunity to explain the role of deuteration in both the drug development and patent process.
A few other interesting events took place on the markets this week, which are discussed briefly herein.
Psychedelic Sector News
MindMed Announces Project Angie, Targeting Pain Indications
Earlier this week, MindMed announced the launch of Project Angie, which aims to develop psychedelics, notably LSD, for the treatment of pain conditions.
At present, the New York-based company has unveiled 2 pain indications that will be explored:
- a severe pain indication, for which LSD will be studied;
- a chronic pain indication.
Researchers collaborating with MindMed have already published studies on this topic, such as this piece from 2020: A low dose of lysergic acid diethylamide decreases pain perception in healthy volunteers.
MindMed plans to submit an IND briefing package for LSD in the treatment of the severe pain indication in the latter half of this year. The package will outline a Phase 2a study.
Small Pharma Secures First Patent
London-based Small Pharma has begun trading on the Canadian TSXV, under ticker symbol DMT – the focus of the company’s R&D. Our editor-at-large Graham Pechenik takes a look at their latest announcement regarding patents…
This week, Small Pharma received an “In Order for Grant” notice for its UK patent application on deuterated DMT. This notice confirms that examination of the application is complete, and a granted patent will issue in June. This will be Small Pharma’s first granted patent from its portfolio of applications on “psychedelic-based medicines,” which has 31 patents pending.
Small Pharma’s allowed patent covers mixtures of DMT and deuterated DMT analogues—i.e., DMT where one or more of the hydrogens has been replaced by its heavier isotope deuterium.
A Primer on Deuteration
Deuteration has long been used as a strategy to obtain new patent protection on a known drug. For example, Atai has issued and pending patents on deuterated etifoxine (an anxiolytic developed in the 1960s), and has in-licensed issued and pending patents from Columbia University on deuterated mitragynine (the primary alkaloid in kratom). Additionally, Cybin currently has deuterated tryptamines in development, for treatment of alcohol use disorder and therapy resistant psychiatric disorders. The first deuterated drug to be approved by the FDA was deutetrabenazine (Austedo) in 2017, for which the FDA notably found that deuteration resulted in a drug with a “different active moiety,” meaning that a deuterated version of a compound may be able to separately receive NCE exclusivity.
Deuteration generally results in changes to the pharmacokinetics of a drug, such as shorter time to onset, lower rates of metabolism, and longer half-life. Small Pharma, for example, explains that its invention takes advantage of “the kinetic isotope effect” exhibited by deuterated DMT analogs “in order to modify, controllably, the pharmacokinetic profile of N,N-DMT, thereby permitting more flexible therapeutic application.” Small Pharma states that it can therefore “enable a finely tuned single dose to maintain a patient in full dissociation from the external world”—“DMT Space”—“for a therapeutically optimised duration without relying on infusion protocols or combination therapy with monoamine oxidase inhibitors in the clinic.” Small Pharma notes that its preclinical DMT candidate SPL028 is covered by its new patent.
More information about the patent, its co-pending U.S. application, and deuteration was discussed by our editor-at-large Graham Pechenik yesterday on Twitter.
Champignon Changes Name to Braxia Scientific
The Toronto-based company, which just emerged from back-to-back cease trade orders that left their stock halted for the better part of the year, has now announced a name change. Champignon Brands will henceforth be known as Braxia Scientific, purportedly to “reflect the integration of ketamine and psychedelic clinics and its research and development priorities.”
We’re not sure what to make of the new name, and the only reference we could find to ‘Braxia’ is a cemetery in Malta.
The ticker changes from SHRM to BRAX.
We couldn’t possibly cover every news story each week. Below are a selection of other headlines:
- Field Trip opens center in Houston, and reveals five new locations underway
- Mydecine shares 2020 financial results and business update
- Gilgamesh Pharmaceuticals closes $27m Series A
Results Reveal Success in MAPS’ Phase 3 MDMA for PTSD Study
Earlier this week, MAPS shared results from their first Phase 3 trial of MDMA-assisted therapy for the treatment of PTSD. The headline results are positive, with 67% of participants in the MDMA group no longer diagnosable with PTSD 2 months post-treatment, versus 32% of those in the placebo group.
In terms of safety, there were no serious adverse events in the MDMA group. Rather, the two serious adverse events recorded were both in the placebo group. Non-serious adverse events, meanwhile, occurred to a greater extent in the placebo group than the MDMA group.
The study is expected to be published in Nature Medicine later this month, and a second Phase 3 trial is currently enrolling participants (enrollment info).
In terms of timelines, MAPS is on-track for potential approval of MDMA-assisted therapy for PTSD in 2023. The FDA has also permitted an expanded access program, which will allow 50 patients to access the treatment prior to FDA approval.
The New York Times: A Psychedelic Drug Passes a Big Test for PTSD Treatment
NYT got the scoop on MAPS’ Phase 3 results (above), which they wrote up in this high-visibility piece.
“This is about as excited as I can get about a clinical trial,” said Gul Dolen, a neuroscientist at Johns Hopkins University School of Medicine, who was not involved in the research. “There is nothing like this in clinical trial results for a neuropsychiatric disease.”
Stay Informed in 2021
We can only expect the rate of change and development in the psychedelic space to continue accelerating in 2021. Stay informed via our various platforms and channels…
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