Midomafetamine

PharmAla Biotech Unveils Phenesafe AI Platform to Accelerate MDXX Drug Discovery

7 days ago

• PharmAla Biotech has launched Phenesafe AI, a specialized technology platform designed to identify and develop novel substituted phenethylamine molecules with potential applications in psychiatric and neurological disorders. • The platform combines QSAR modeling developed with the University of Windsor and AI chemical pathway tools to streamline target identification, screening, and patenting of new MDXX class compounds. • As the only company currently providing clinical-grade MDMA for patient treatments outside trials, PharmAla aims to address unmet needs in mental health through its "regulatory first" approach to psychedelic medicine development.

Texas Proposes $25 Million for First FDA-Approved Ibogaine Clinical Trials for PTSD and Addiction

15 days ago

• Republican lawmakers in Texas are pushing legislation to allocate $25 million for the first FDA-approved clinical trials of ibogaine, a psychoactive compound derived from the West African iboga plant. • A 2023 UC Berkeley study revealed ibogaine creates a prolonged "critical period" in the brain lasting over a month, allowing patients to develop new neural pathways and discard harmful behavioral patterns. • Despite being illegal in the U.S., ibogaine has shown promising results for veterans suffering from PTSD, traumatic brain injury, and opiate addiction, with former Texas Governor Rick Perry advocating for its reclassification.

Hawaii Advances Psychedelic-Assisted Therapy Research Bill with $4 Million Funding Potential

a month ago

• Hawaii's House Finance Committee unanimously approved a Senate-passed bill establishing a two-year pilot program for psychedelic-assisted therapy research, potentially providing $4 million in combined public-private funding. • The legislation would create a "mental health emerging therapies special fund" under the Office of Wellness and Resilience to support clinical trials and establish research partnerships for treatments targeting PTSD, depression, and other mental health conditions. • The initiative positions Hawaii to potentially lead national efforts in psychedelic medicine, with strong support from veterans' organizations and mental health advocates who cite promising clinical trial results for MDMA and psilocybin therapies.

GH Research's Inhaled Psychedelic GH001 Achieves Significant Results in Phase IIb Trial for Treatment-Resistant Depression

4 months ago

• GH Research's GH001, an inhaled 5-MeO-DMT, met its primary endpoint in a Phase IIb trial for treatment-resistant depression, showing a significant reduction in MADRS scores. • The trial demonstrated ultra-rapid responses, with substantial reductions in MADRS scores observed as early as two hours post-treatment with GH001. • GH001 led to a high remission rate at six months in the open-label extension portion of the trial, indicating a sustained therapeutic effect. • The company reported no serious adverse events, suggesting a favorable safety profile for GH001 in treating TRD.

5-MeO-DMT Nasal Spray Shows Promise in Phase 2a Alcohol Use Disorder Trial

4 months ago

• A single dose of BPL-003, a synthetic intranasal 5-MeO-DMT formulation, combined with behavioral therapy, significantly reduced alcohol consumption from 9.3 to 2.2 units per day over 12 weeks. • The Phase 2a trial demonstrated impressive outcomes with 50% of participants maintaining complete abstinence throughout the study period and mean abstinent days increasing from 33% to 81%. • The treatment showed favorable safety profile with only mild to moderate adverse events and efficient clinical administration, allowing patient discharge within approximately two hours.

FDA Issues Draft Guidance on Psychedelic Drug Development for Mental Health Conditions

4 months ago

• The FDA has issued draft guidance to assist sponsors in developing psychedelic drugs for psychiatric disorders, substance use disorders, and other medical conditions. • The guidance focuses on psilocybin, LSD, and MDMA, offering recommendations for chemistry, manufacturing, controls, non-clinical, clinical pharmacology, abuse potential assessment, and clinical aspects. • The FDA emphasizes the importance of including psychological support, such as psychotherapy, in clinical trials and suggests strategies to mitigate bias and quantify the psychotherapy component's contribution. • Subject safety is a key concern, with recommendations for abuse potential assessment, the presence of two monitors during treatment, and heightened informed consent to ensure patients are aware of potential perceptual and cognitive changes.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

FDA Rejects Lykos Therapeutics' MDMA Therapy for PTSD, Casting Doubt on Psychedelic Treatment Path

5 months ago

• The FDA rejected Lykos Therapeutics' application for MDMA-assisted therapy for PTSD, citing insufficient evidence and flawed study design, a major setback for psychedelic medicine. • Key concerns included 'functional unblinding' in trials, potential bias, and questions about the necessity and contribution of psychotherapy to the treatment's benefits. • Lykos faces the prospect of conducting another Phase 3 trial, leading to significant delays and increased costs, while the broader psychedelic therapeutic area faces increased scrutiny. • The FDA's decision raises questions about the balance between patient safety and scientific rigor in psychedelic research, particularly regarding blinding methods and therapeutic approaches.

Drug Development Updates