Before the widespread fear-mongering in Western media and culture around LSD it was becoming rather popular in the psychiatry community in both North America and Europe. In the ’50s LSD was used in European psychotherapy clinics in an approach called psycholytic therapy—meaning “the dissolution of tension or conflicts in the human psyche”—in which patients took lower doses of LSD over a series of sessions. In the 60’s the drug reached mainstream popularity and to this day is widely recognized as the most significant decade with regards to psychedelic usage in arts, culture, and therapy. Things were looking bright until the political situation in the US changed, and foreign wars changed the course of history.
By the early-mid 70’s the Nixon administration became extremely paranoid that hippies who thought the Vietnam War was dumb would influence the American Public, and it did. As the war dragged on support back home declined, but instead of introspection, the establishment needed a scapegoat – burnouts. Nixon wanted revenge, and making their favourite drugs illegal was one of his methods. This is when the war on drugs got put on steroids. But now, things are starting to open up. California’s bill to decriminalize psychedelics is coming faster than expected with several more states set to follow suit in the coming months and years. Companies are creating new drugs, and bringing old ones back from the dead.
BetterLife Pharma (BETR.C) currently has four products in its pipeline including TD-0148A – an LSD derivative. It’s not a novel compound (NCE) the company is developing, which allows them to move faster. The downside is the inability to patent the formulation, unlike an NCE. Human clinical trials have been conducted several decades ago with TD-0148A. However, the controlled substance classification of LSD prevented most further research into the drug. It was really bad timing as there was a new wave of exciting research brewing in the psychedelics community. That research that has been collecting dust for the last 50 years could be extremely valuable to a modern-day company looking to introduce new drug discoveries to the world. It’s like getting part of a turn-key solution.
BetterLife wants to treat mental health disorders including Treatment-resistant Depression (TRD) and migraines. No TD-0148A studies in TRD have been conducted to date, the company sees this as an opportunity to break new ground.
Derivatives provide the workaround while arcane laws remain in practice. A derivative isn’t subject to schedule 1 controlled substance restrictions, meaning BetterLife can move ahead with TD0148A large-scale production and clinical trials.
TD-0148A is currently at the preclinical stage of development. The company intends to set up GMP manufacturing of TD-0148A alongside preclinical and IND enabling toxicology studies. The TD0148A Investigational New Drug (“IND”) filing is projected to be filed by the fourth quarter of 2021, with the start of Phase 1 clinical trials, followed in 2022 by the initiation of two Phase 2 trials: one trial in TRD, and trial one in migraines.
Speed is an important factor in this sector, and BetterLife’s move to go forward with an LSD derivative with research already behind it could allow them to move quicker than some of the bulkier companies with huge R&D budgets looking to re-invent the wheel. Those companies get rewarded with valuable patents, but, there’s something to be said about being lean, especially in startup mode in a constantly shifting sector.