Clearmind’s FDA-Approved CMND-100 Trial Moves Forward in the US

Clearmind Medicine Inc, a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced 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 US FDA-approved phase I/IIa clinical trial for the treatment of alcohol use disorder (AUD), a condition affecting over 28 million adults in the US alone.

CMND-100, a proprietary MEAI-based oral drug candidate, represents a potential breakthrough in AUD treatment, targeting the reduction of alcohol consumption and cravings through a novel mechanism of action. The drug’s arrival in the US keeps Clearmind on track to launch its first-in-human clinical trial.

“This milestone brings us closer to demonstrating CMND-100’s potential as a transformative treatment for Alcohol Use Disorder,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “With an estimated $35 billion global market opportunity in AUD treatments and limited effective solutions available today, Clearmind is strategically positioned to disrupt the space with a novel, science-backed therapeutic.”

Clearmind’s phase I/IIa clinical trial, approved by the US Food and Drug Administration (FDA), will assess CMND-100’s safety and efficacy in reducing alcohol consumption. The study will be conducted at two of the leading research institutions in the United States, Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine. The Israeli trial will be conducted at IMCA (Israel Medical Center for Addiction), located in Ramat Gan, Israel.

Clearmind Medicine’s intellectual portfolio currently consists of nineteen patent families including 31 granted patents. The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

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