5-methoxy-2-aminoindane (CMND-100) / Clearmind Medicine - LARVOL DELTA

Clearmind Medicine Completes the Initiation of its Alcohol Use Disorder Phase I/IIa Clinical Trial at all Current Clinical Sites (GlobeNewswire) - "Clearmind Medicine Inc...today announced the initiation of its U.S. clinical trial site at the Yale School of Medicine’s Department of Psychiatry. With this initiation, the Company has now activated all planned sites for its clinical trial for its Phase I/IIa clinical trial in Alcohol Use Disorder ('AUD') and can begin patient enrollment. Clearmind has completed all necessary preparations for the clinical trial, including obtaining Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to start the Phase I/IIa clinical trial, Institutional Review Board (IRB) approvals from each clinical site, launch of its Electronic Data Capture (EDC) system to support the clinical trial and the arrival of its drug candidate, CMND-100, into the United States following successful manufacturing."

Trial status • Addiction (Opioid and Alcohol)

Clearmind Medicine Announces First U.S. Clinical Site Initiation for CMND-100 Clinical Trial in Patients with Alcohol Use Disorder (GlobeNewswire) - "Clearmind Medicine Inc...announced today that it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of Medicine. The first in human clinical trial will investigate the safety, tolerability and full pharmacokinetic profile of Clearmind’s innovative treatment, CMND-100, in Alcohol Use Disorder (AUD) patients."

Trial status • Addiction (Opioid and Alcohol)

Role of Composition and Temperature in Shaping the Structural and Optical Properties of Iodide-Based Hybrid Perovskite Thin Films Produced by PVco-D Technique. (PubMed, Materials (Basel)) - "To answer these questions, the surface topography was analyzed using the AFM method, spectroscopic measurements were carried out in the UV-Vis-NIR range, and photoluminescence measurements were performed in a wide temperature range-from about 80 K to 310 K. The results indicate that the composition changes the surface topography, forming increasingly higher crystallites (up to 606%) with increasing methylammonium content. The transition temperature from the orthorhombic to the tetragonal phase was determined for each composition at about 140 K. For the composition of 30% MEAI + 70% PbI2, the phase transition temperature from tetragonal to cubic was determined at a temperature close to RT."

Journal

Clearmind Medicine’s FDA-Approved Clinical Trial for CMND-100 Moves Forward as Drug Arrives in the U.S., Advancing Toward Key Milestones (GlobeNewswire) - "Clearmind Medicine Inc...announced today that its innovative drug candidate, CMND-100, has arrived in the United States following successful manufacturing. This marks a key milestone as the Company prepares to initiate its FDA-approved Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD), a condition affecting over 28 million adults in the U.S. alone....The drug’s arrival in the U.S. keeps Clearmind on track to launch its first-in-human clinical trial."

Commercial • Addiction (Opioid and Alcohol)

Clearmind to Evaluate Intranasal Delivery of Its Psychedelic Drug Combination (GlobeNewswire) - "Clearmind Medicine Inc...announced today that it has signed a non-binding Letter of Intent (LOI) with Polyrizon Ltd...to develop a novel intranasal formulation for its psychedelic-based treatment applications. The collaboration will explore the potential of Clearmind’s proprietary drug candidate, 5-Methoxy-2-aminoindane (MEAI), alone or in combination with Palmitoylethanolamide (PEA), through intranasal administration...Under the terms of the non-binding LOI, Clearmind and Polyrizon will conduct research and development efforts to achieve a proof of concept for an intranasal formulation of MEAI and MEAI-PEA combinations. The companies will assess the feasibility of intranasal drug delivery, which offers several potential advantages over traditional administration methods, including faster absorption and onset of action, high bioavailability for increased therapeutic effects and enhanced patient compliance due to non-invasive administration."

Commercial • CNS Disorders • Psychiatry

Clearmind Medicine Announces Initiation of First in Human Clinical Trial with CMND-100 in Alcohol Use Disorder Patients (GlobeNewswire) - "Clearmind Medicine Inc...announces today that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its innovative treatment, CMND-100, in Alcohol Use Disorder (AUD) patients....The first site to be initiated is IMCA in Israel...In addition to the IMCA Center in Israel, the trial will be conducted at two prestigious U.S. research institutions, Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine."

Trial status • Addiction (Opioid and Alcohol)

Clearmind Medicine Receives IRB Approval for its FDA-Regulated Clinical Trial (GlobeNewswire) - "Clearmind Medicine Inc...announced it has received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100, targeting alcohol use disorder (AUD)....The clinical trial will assess CMND-100’s ability to reduce alcohol cravings and consumption among individuals with moderate to severe AUD. The study is designed to gather critical data supporting the advancement of CMND-100 through the clinical pipeline."

Trial status • Addiction (Opioid and Alcohol)

A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Clearmind Medicine Inc. | Trial completion date: Sep 2024 ➔ Oct 2025 | Trial primary completion date: Jun 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol)

5-Methoxy-2-aminoindane Reverses Diet-Induced Obesity and Improves Metabolic Parameters in Mice: A Potential New Class of Antiobesity Therapeutics. (PubMed, ACS Pharmacol Transl Sci) - "These findings provide compelling evidence for the antiobesity effects of MEAI treatment and call for further preclinical testing. In conclusion, our study highlights the potential of MEAI as a novel therapeutic approach for treating obesity and its associated metabolic disorders, offering hope for the development of new treatment options for this global health challenge."

Journal • Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Psychiatry

Investigation of the Effect of the Passivation on the Charge Transfer from MAPbI3 to Electron Transport Layer Using a Heterodyne Transient Grating Spectroscopic Technique. (PubMed, Chemphyschem) - "We fabricated MAPbI3 perovskite thin films with ZnO on a glass substrate, in which a passivation layer (Phenethylammonium iodide (PEAI); p-methoxyphenethylammonium iodide (CH3O-PEAI); 2-methoxyethylammonium iodide (MEAI)) was inserted between two layers...Based on the accelerated recombination between photo-generated holes remaining in the MAPbI3 layer and surface-trapped electrons in ZnO and the increase in the number of the trapped electrons in ZnO when either CH3O-PEAI or PEAI was applied, we successfully revealed that the charge transfer efficiency was enhanced by the insertion of the passivation materials including a benzene ring stabilizing the defect states. Particularly, it was demonstrated that CH3O-PEAI showed the highest increase in the charge transfer efficiency, which could be attributed to the high electron density in the benzene ring, resulting from the existence of the electron donating group, CH3O, and its role in the effective transition from 3D to..."

Journal

A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Clearmind Medicine Inc. | Initiation date: Sep 2023 ➔ Apr 2024

Trial initiation date • Addiction (Opioid and Alcohol)

Investigation of New Psychoactive Substances (NPS), Other Illicit Drugs, and Drug-Related Compounds in a Taiwanese Wastewater Sample Using High-Resolution Mass-Spectrometry-Based Targeted and Suspect Screening. (PubMed, Molecules) - "Additionally, the presence of 5-methoxy-2-aminoindane (MEAI) in the wastewater indicates that drug dealers have recently sold this potential NPS to evade drug regulations. This study firstly reports the HRMS-based comprehensive profile of NPS, other illicit drugs, and drug-related compounds in Taiwan, which could be applied as biomarkers for estimating the consumption of drugs."

Biomarker • Journal • Pain

A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Clearmind Medicine Inc.

New P1/2 trial • Addiction (Opioid and Alcohol)

Clearmind Medicine Announces First US Site for its Phase I/IIa Clinical Trial Evaluating CMND-100 in Patients with Alcohol Use Disorder (GlobeNewswire) - "Clearmind Medicine...today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder ('AUD'). Yale School of Medicine’s Department of Psychiatry is the first US-based clinical site to join the company's first-in-human (FIH) trial."

Trial status • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry

MEAI: an artificial intelligence platform for predicting distant and lymph node metastases directly from primary breast cancer. (PubMed, J Cancer Res Clin Oncol) - "The proposed MEAI system can provide a non-invasive approach to assess the metastatic probability of patients with primary breast cancer."

Journal • Breast Cancer • Oncology • Solid Tumor

Clearmind Medicine Announces Clinical Supply Agreement for its Upcoming Clinical Trial (GlobeNewswire) - "Clearmind Medicine Inc...announced an agreement with IMP Clinical Supply Services...IMP will be responsible for the global clinical supply chain of Clearmind’s proprietary drug candidate CMND-100 from manufacture to the various clinical sites. IMP is known for its comprehensive, tailor-made clinical supply services that address all study requirements. The array of services to be performed are fully compliant with GMP, GCP, and GDP standards. Clinical drug supply is a critical factor for trial success so collaboration with best-in-class clinical drug supply vendor forestalls the possibility of it being a bottleneck to successful drug delivery. Moreover, it can also deliver enormous benefits, including better investigator and patient experiences as well as cost savings in clinical drug supply. The company's clinical trial is expected to commence in Q2 2023 in the United States and in Israel."

Licensing / partnership • New trial