SCHIZOPHRENIA

Bristol Myers Squibb's newly FDA-approved COBENFY introduces a novel agonist mechanism for treating schizophrenia, marking the first new class of medication for this condition in decades. The treatment selectively targets M1 and M4 receptors in the brain without blocking D2 receptors. It demonstrated statisticallysignificant reductions in schizophrenia symptoms in Phase 3 trials,with a 9.6-point and an 8.4-point reduction in the PANSS total scorecompared to placebo at week five. The announcement led to a 20%jump in BMS’ stock, indicative of the potential impact the approval will have on the market landscape.

SCHIZOPHRENIA

Results from Anavex Life Science's Phase 2 study of ANAVEX 3-71 for schizophrenia E3 were released earlier this month, demonstrating a dose-dependent impact on EEG biomarkers - 40 Hz ASSR ITC and Resting StateAlpha Power - indicative of improved neuralsynchronization and sensory gating. The treatment demonstrated positive effects on schizophrenia symptoms without severe side effects, a challenge faced by existing treatment options. ANAVEX 3-71’s novel mode of action could address all symptomatic domains of schizophrenia,and will be further explored through Part B of the study expected to be completed in early 2025.

SUBSTANCE USE DISORDERS

Recently published results from an academicretrospective cohort study demonstrated that GLP-1treatments had a significant impact on substance use disorders. The study of over 100 million patients found that patients with GIP/GLP-1 RA prescriptions had a positive effect for patients with comorbid opioid andalcohol use disorders. This effect was measuredthrough lower rates of opioid overdose (a IRR 0.60,95% CI 0.43–0.83) and alcohol intoxication (0.50,95% CI 0.40–0.63) among patients treated for type2 diabetes and obesity with GIP/GLP-1 receptoragonists compared to patients without.

ALTERNATIVE TREATMENTS

Boehringer Ingleheim recently released results from its Phase 2 study evaluating the effects of ketamine on brain activity during negative emotional processing and how these effects are influenced by lamotrigine, which inhibitsglutamate release. In a randomized controlled trial with 75healthy subjects, acute ketamine administration was found to decrease activity in the hippocampus and Default ModeNetwork (DMN) while increasing fronto-limbic coupling;these effects were modulated by lamotrigine. Ketamine'ssustained impact was a notable reduction in posterior DMN activity 24 hours post-administration, an effect alsomitigated by lamotrigine pre-treatment.

MAJOR DEPRESSIVE DISORDER

In a recently completed Phase 2a study, Supernus’experimental therapy, SPN-820, successfully demonstrated a “rapid and substantial” effect in adults with major depressive disorder (MDD).Compared to most currently availableantidepressants, like SSRIs, which can take several weeks to show noticeable effects, SPN820’s mode of action acts within hours. Although the small trial demonstrated promising results,additional, higher-powered studies are necessaryfor drug approval.

ALTERNATIVE TREATMENTS

Exploration of psilocybin as an alternative treatment for mentalhealth conditions has expanded globally, with advances made in clinical research globally. In Australia, Psyence Biomedical has expanded its Phase 2b trial for a psilocybin-based treatment targeting Adjustment Disorder in palliative care. This study is aiming to launch patient recruitment by December and projectstopline data for 2025. The UK's National Institute for HealthResearch recently announced funding for a study to investigatepsilocybin’s effect on opioid addiction relapse rates. US-based AJNA BioSciences recently publicized their efforts to overcome one of the biggest challenges hindering the use of psychedelics -the variability in the biology of the raw materials - in pursuit of FDA approval for their psilocybin-derived antidepressant.