Announcement • Aug 14
Clearmind Medicine Advances CMND-100 To Alcohol Use Disorder Patients After Achieving Primary Safety Endpoint Clearmind Medicine has received Independent Data and Safety Monitoring Board (DSMB) approval to advance its clinical evaluation of CMND-100 in patients with Alcohol Use Disorder (AUD) - a key milestone in the progression of the Company’s clinical development program. Clearmind Medicine Inc. announced that its independent DSMB has unanimously approved advancing the Company's ongoing FDA-regulated Phase I/II clinical trial to parts B and C (the two of the remaining 3 parts) of the clinical trial, evaluating CMND-100 in patients actively suffering from AUD as well as in healthy participants. The DSMB's approval follows the successful completion of Part A of the study, where CMND-100 achieved its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participates. After reviewing the full safety dataset from Part A, the DSMB unanimously recommended advancing the study to Parts B and C in accordance with the previously approved study protocol. Part B marks a key clinical milestone for Clearmind, as CMND100 will be evaluated for the first time in human patients with moderate to severe AUD, unlike Part A that included only healthy participants. The part B phase will enroll, sequentially, two cohorts of six patients receiving 80 mg and 160 mg doses, respectively, and will assess safety, tolerability, and early signals of clinical activity, including CMND100’s potential to reduce alcohol consumption and craving. Part C will be conducted, concurrently with Part B, in healthy participants and will evaluate CMND-100 at a fixed daily dose of 160 mg administered over five consecutive days. This double-blind, placebo-controlled segment is expected to further characterize the safety and tolerability profile of CMND-100. The Phase I/II clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in reducing drinking patterns and alcohol craving in individuals with moderate to severe AUD of CMND-100. The study is being conducted at clinical sites, including Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. CMND-100 is Clearmind’s proprietary oral formulation of MEAI (5-methoxy-2-aminoindane). The Company is developing it as a non-hallucinogenic neuroplastogen-derived candidate intended to promote adaptive neuroplasticity while avoiding the perceptual effects associated with classical psychedelics. This profile aims to support scalable treatment models that do not require intensive clinical supervision or prolonged monitored sessions. Announcement • Aug 13
Clearmind Medicine Reports Positive Permeation Results For Intranasal MEAI Formulation Clearmind Medicine Inc. announced positive permeation study results from its ongoing intranasal MEAI development program. The new findings confirm that the enhanced nasal residence time previously demonstrated with the proprietary intranasal MEAI formulation does not compromise the permeation characteristics of Clearmind's proprietary MEAI (5-Methoxy-2-aminoindane). Clearmind’s early-stage studies of its intranasal MEAI formulation have generated highly promising results, supporting the continued development of this innovative treatment approach. The positive data generated to date supports the company’s development strategy and provide compelling support for the continued advancement of the intranasal program. Together, these findings provide additional support for the continued evaluation of MEAI as a differentiated therapeutic candidate for mental-health disorders, including alcohol use disorder (AUD), as well as for weight management, obesity, and metabolic conditions. The permeation study builds on recently reported ex vivo mucoadhesion results demonstrating that intranasal MEAI remains associated with nasal tissue substantially longer than a conventional MEAI solution. These findings show markedly enhanced retention of MEAI on nasal mucosa reinforcing its potential to achieve extended nasal residence time within the nasal cavity. Together, the data further supports the continued development of Clearmind’s intranasal program and highlights the formulation’s potential as a differentiated intranasal delivery approach for MEAI. To evaluate whether the enhanced retention of intranasal MEAI influences its release and membrane transport, permeation studies were performed using Franz diffusion cells, a widely accepted model for assessing intranasal drug delivery performance. The experiments used a cellulose dialysis membrane and simulated nasal electrolyte solution under physiologically relevant conditions. Equivalent MEAI doses were applied as either the intranasal formulation or a conventional reference solution, enabling a direct head-to-head comparison of permeation behavior over time. The results showed rapid and extensive permeation for both formulations. While intranasal MEAI displayed a slightly more gradual early-phase release profile, overall permeation was highly comparable to the reference solution. By 180 minutes, both formulations achieved near-complete permeation with cumulative permeation reaching 97.35% for intranasal MEAI and 98.34% for the conventional formulation. This data indicates that incorporating MEAI into the mucoadhesive intranasal delivery system does not materially impair drug transport. When combined with previously reported mucoadhesion results, the findings suggest that Clearmind's intranasal strategy may successfully extend nasal residence time while maintaining efficient permeation - two essential attributes for effective intranasal drug delivery. Together, the results demonstrate three key development achievements supporting the advancement of the intranasal MEAI development program: Formulation compatibility: MEAI successfully integrated into the intranasal platform as a stable, fully soluble formulation. Enhanced mucoadhesion and prolonged nasal residence: the intranasal MEAI formulation demonstrated substantially longer nasal retention compared with a MEAI saline solution. Preserved permeation kinetics: extended residence time was achieved without compromising MEAI transport across the tested membrane. Announcement • Aug 06
Clearmind Medicine Advances Clinical Evaluation Of CMND-100 In Alcohol Use Disorder Study Clearmind Medicine has received Independent Data and Safety Monitoring Board (DSMB) approval to advance its clinical evaluation of CMND-100 in patients with Alcohol Use Disorder (AUD) - a key milestone in the progression of the Company’s clinical development program. The independent DSMB has unanimously approved advancing the Company’s ongoing FDA-regulated Phase I/II clinical trial to parts B and C (the two of the remaining 3 parts) of the clinical trial, evaluating CMND-100 in patients actively suffering from AUD and in healthy participants, respectively. The DSMB’s approval follows the successful completion of Part A of the study, where CMND-100 achieved its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participates. After reviewing the full safety dataset from Part A, the DSMB unanimously recommended advancing the study to Parts B and C in accordance with the previously approved study protocol. Part B marks a key clinical milestone for Clearmind, as CMND100 will be evaluated for the first time in human patients with moderate to severe AUD, unlike Part A that included only healthy participants. This phase will enroll, sequentially, two cohorts of six patients receiving 80 mg and 160 mg doses, respectively, and will assess safety, tolerability, and early signals of clinical activity, including CMND100’s potential to reduce alcohol consumption and craving. Part C will be conducted, concurrently with Part B, in healthy participants and will evaluate CMND-100 at a fixed daily dose of 160 mg administered over five consecutive days. This double-blind, placebo-controlled segment will further characterize the safety and tolerability profile of CMND-100. The multicenter Phase I/II clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in reducing drinking patterns and alcohol craving in individuals with moderate to severe AUD of CMND-100. The study is being conducted at clinical sites, including Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. CMND-100 is Clearmind’s proprietary oral formulation of MEAI (5-methoxy-2-aminoindane). The Company is developing it as a non-hallucinogenic neuroplastogen-derived candidate intended to promote adaptive neuroplasticity while avoiding the perceptual effects associated with classical psychedelics. This profile aims to support scalable treatment models that do not require intensive clinical supervision or prolonged monitored sessions. 
