Major Depressive Disorder: Small Pharma’s Phase 2 DMT Trial, BetterLife’s Preclinical LSD Trial
Short-acting psychedelics biotech company Small Pharma Inc. DMTTF shared positive outcomes from its Phase 2a study of SPL026, the first placebo-controlled trial of the DMT-based short-duration psychedelic compound for the treatment of Major Depressive Disorder (MDD).
The trial assessed both the efficacy and safety of a 21.5mg IV dose of SPL026 paired with supportive therapy in 34 patients with moderate to severe MDD. It was split into two phases, the first a two-week blinded, randomized, placebo-controlled trial followed by a 12-week open-label stage in which all participants received one dose of the psychedelic compound.
Analyses of secondary and exploratory endpoints like effects on self-reported depression, anxiety and well-being -areas often negatively impacted by depression- demonstrated that patients receiving at least one dose of the psychedelic experienced clinically relevant improvements in function and mood.
Learn more on the Phase 2 trial HERE.
Meanwhile, comparably less advanced but still pretty eagerly, BetterLife Pharma Inc. BETRF’s lead drug candidate LSD analog BETR-001 has also shown positive results in a preclinical study assessing it as a potential treatment for mood disorders.
In preclinical and IND-enabling studies, BETR-001 is a non-hallucinogenic and non-controlled LSD derivative with the potential for self-administration, which BetterLife is aiming to patent for the treatment of Major Depressive Disorder (MDD,) anxiety disorder and neuropathic pain, among other conditions.
These outcomes of 2-bromo-LSD or BETR-001’s therapy, published in the peer-reviewed journal Cell Report, further support previous positive data through an extensive pharmacological characterization of the novel compound compared to LSD.
Distinct CNS receptors pharmacological differences between BETR-001 and LSD included:
5-HT2A receptor partial agonism and no psychedelic-like effects in vivo for BETR-001 in contrast to LSD
5-HT2B agonism was caused by LSD but not by BETR-001, leading to a potentially safer cardiovascular profile.
BETR-001 induces neuroplasticity in vitro and in vivo while promoting active coping behavior in mouse models of depression and anxiety.
Learn more on this non-hallucinogenic version of LSD and its upcoming development steps HERE.