This week in psychedelic business news, Small Pharma (TSXV: DMT) (OTCQB: DMTTF) announced additional studies for two DMT-inspired novel compounds. Following a successful Phase 1 study of lead candidate SPL026, the neuroscience company is planning a drug interaction study for 2022 to assess the impact of antidepressants on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy. Additionally, another study this year will compare the treatment profile of intramuscular (IM) versus intravenous (IV) modes of administration. Further, Small Pharma will initiate a Phase I study of another DMT-inspired candidate, SPL028, with psychotherapy among healthy volunteers to assess safety, tolerability, pharmacodynamics and pharmacokinetics of IM and IV administration. This study will allow Small Pharma to better understand the profile of SPL028 as a therapeutic candidate and identify the optimal route of administration in a clinical setting.
Wellbeing Digital Sciences (NEO: MEDI) (OTC: KONEF) (FRA: SQ2) has promoted current Chief Research Officer Najla Guthrie, as Chief Executive Officer, effective March 31. Guthrie, who is also the president of KGK Science, replaces Adam Deffett, the interim CEO who will transition out of the role but will continue in his former capacity as vice president of capital markets and communications. “I greatly appreciate the opportunity to lead Wellbeing as we continue to pursue our vision of becoming a leader in mental health and wellness across North America,” Guthrie says. “We have a leadership team with great depth, decades of experience and detailed knowledge of the industry. Naturally, I will continue to steward KGK Science forward as a leading clinical research organization.”
Core One Labs’ subsidiary Akome Biotech has entered into an agreement with the Universidad Complutense de Madrid to commence neurogenesis stimulation and modeling studies research, to advance the development of patent-pending psychedelic compounds that target Alzheimer’s Disease, Parkinson’s Disease, Major Depressive Disorder and Ischemic Stroke. “I believe that the treatment of individuals with neurological disorders through the use of psychedelic based pharmaceuticals, will become a major focus of mental healthcare in the near future,” says CEO Joel Shacker. “The groundbreaking work that Universidad Complutense is doing for Akome, will contribute significantly to the advancement of our drug formulations as we work to commercialize our patents.”
Last but not least in this week’s roundup of psychedelic business news, Health Canada has given the green light for pharmaceutical company Apex Labs to proceed with a Phase 2a clinical trial evaluating the safety, tolerability, and efficacy of its next-generation psilocybin candidate APEX-002-A01 in veterans with post-traumatic stress disorder. The company has secured its veteran patient base, clinical trial location, and qualified investigator for the program expected to launch as early as second or third quarter of this year. “The team at Apex Labs has worked tirelessly to achieve this milestone and believe our company has quietly positioned itself to be a leader in the North American psychedelics space through a strategy utilizing our clinical expertise, connection to veteran patients and our commitment to broader access to regulated psychedelic drug products for therapeutic benefit,” says Apex CEO Tyler Powell.