SPL026
Small Pharma (DMT.V) is a London-based psychedelics company focusing on DMT-assisted psychotherapy for depression, and they’re already doing Phase 1 clinical trials, with Phase 2 on the way. They have also raised a ton of capital through multiple brokered and non-brokered private placements totaling $73 million CAD with backing from Cannacord and Eight Capital.
Small Pharma initiated Phase 1 of their clinical program into DMT-assisted therapy in February 2021. Phase 1 sounds early, but many of Small Pharma’s peers are still doing pre-clinical work and don’t yet meet the necessary requirements to move into Phase 1. So while Small Pharma may not be as far along as Compass (CMPS.Q) or MindMed (MYMD.Q), but they are in a good spot for trial timelines. The company has created its own novel compound (NCE) of DMT which they have named SPL026.
This means if successful, the company can patent it – adding valuable IP and potentially being a game-changer in psychedelic-assisted therapy. The companies who produce the first FDA-regulated drugs with the research to back them up are in for a big payday. It could happen sooner rather than later with all of these ketamine clinics popping up that use similar NCE’s to the ones being developed by companies like Small Pharma.
During 2016-2018, Small Pharma progressed preclinical development of SPL801B, an optimized oral dosage form of a known active metabolite of ketamine in order to develop an oral rapid-acting antidepressant. In conjunction with its R&D progress, Small Pharma adopted an IP strategy surrounding SPL801B, which to date, is represented by a portfolio of 12 patent applications (11
patents pending and 1 patent granted).
In 2019, Small Pharma switched up its R&D focus to explore the drug development opportunities for a psychedelic-based medicine. By 2019, scientific research within this field was accelerating – providing the support of potential of tryptamine-based psychedelics to deliver a rapid-acting, long-lasting antidepressant effect, in conjunction with psychotherapy.
Depression
Small Pharma is partnering up with Hammersmith Medicines Research for the blinded, two-part Phase I/IIa clinical trial which commenced in Q1 2021. Phase I of the study aims to demonstrate the safety and tolerability of different dose levels of SPL026. This will be the first time DMT is given to people with moderate to severe depression in a clinical trial. Dr. Carol Routledge, CSO of Small Pharma said: “We believe the impact will be almost immediate, and longer-lasting than conventional antidepressants.”
It’s estimated that more than 322 million individuals globally suffer from depression, with approximately one-third of individuals achieving inadequate response to two or more pharmacotherapies currently on the market. Over $200 billion USD is spent annually in the U.S. alone on healthcare for depression.
Antidepressant sales are forecast to reach over $19 billion USD by 2023. The currently available treatments have numerous flaws for treating depression like delayed treatment response, high addiction and relapse rates, and severe withdrawal symptoms. Small Pharma believes ‘there is an opportunity to identify a new generation of treatments for depression that have a more rapid onset of action, sustained treatment effects, and improved side-effect profile.’
Small Pharma is one of the first public companies to take a look at DMT, but there is a growing popularity for the drug worldwide.
Ayahuasca NCE?
DMT is chemically similar to the neurotransmitter serotonin, which is involved in a variety of physiological functions in humans, including eating, sleep, and mood regulation. The molecule has a lack of research behind it because of its illegal status despite it being a naturally occurring molecule in humans, animals, and plants. In 2013, MAPS completed the first-of-its-kind study using ayahuasca to investigate treating substance abuse disorders. DMT is one of the active ingredients in ayahuasca, a plant born out of the Andes region of South America.
The subjects in the study included 12 members of a rural First Nations community, several of whom had been through numerous unsuccessful treatments. The treatment consisted of a four-day retreat facilitated by Dr. Gabor Mate. The study combined four days of group counseling with two expert-led ayahuasca ceremonies. Group counseling sessions consisted of various psychosomatic techniques mixed with group sharing and dialogue. The study’s findings showed statistically significant improvements that were demonstrated through assessing hopefulness, empowerment, mindfulness, and quality of life meaning and outlook subscales.
Ayahuasca is made by brewing the Banisteriopsis caapi vine with the shrub Psychotria viridis, which contains DMT. The brew is traditionally made by a shaman, who also leads the ayahuasca ceremony. This can last up to eight hours (the effects of the drugs typically last around six) and often includes purging through vomiting, which is believed to cleanse the body and release negative emotions.
In Iquitos, one of Peru’s ayahuasca hotspots, there are more than 40 retreats offering ceremonies, with prices as high as $3,000 for a 10-night stay. The influx of tourists has also driven up the price of ingredients for the potent hallucinogenic brew – the Banisteriopsis caapi vine has tripled in value in the past six years and is now being grown commercially. As the perception of ayahuasca shifts and prices rise, indigenous communities risk being unable to take part in a practice that forms a key part of their spiritual identity. It’s also not natural to mass-produce so environmental degradation is also something to consider. Palo Santo, a Peruvian wood that smells amazing when burned has been listed as endangered due to its worldwide popularity. There are synthetic versions of it now that market themselves as an environmentally healthy alternative. So maybe an ayahuasca NCE could actually be good for the world. With the way things are going now, it doesn’t seem sustainable.