Trial Planned for BMND08, Natural Psychedelic, in Easing Depression

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by Patricia Inacio, PhD |

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A Phase 2 clinical trial will test BMND08, an investigational oral therapy based on a natural psychedelic, in treating depression and anxiety in people with Alzheimer’s disease, its developer, Biomind Labs, reported.

The company’s announcement follows the trial’s approval by an institutional review board in Argentina.

“As we continue to move forward with our efforts in identifying indications where we can provide significant improvement in patients suffering from mental health, we are more than pleased to announce the approval of a Phase II clinical trial for our BMND08 novel drug candidate … to attenuate depression and anxiety states in patients with Alzheimer’s-type cognitive impairment,” Alejandro Antalich, CEO of Biomind Labs, said in a press release.

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Evidence suggests that anxiety and depression contribute to Alzheimer’s, supporting the need for better and targeted therapies to help ease these symptoms.

“While the current practice guidelines consistently refer to the management of symptoms as central to the treatment of Alzheimer’s disease, the lack of established effective treatments continues to motivate us to generate novel therapeutic solutions,” Antalich said.

Biomind Labs is developing a novel generation of medicines for neurological and psychiatric disorders based upon fast-acting psychedelics already known to science.

BMND08 is an oral formulation of a natural psychedelic called 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) that is found in a great variety of plants in South America. A brew made from such plants, called ayahuasca, is used in rituals by indigenous tribes there. Recent studies are reported to suggest 5-MeO-DMT analogs, including ayahuasca, might treat depression.

Two previous Phase 2 clinical trials in other formulations of DMT in people with treatment-resistant depression have either been conducted or are underway.

“Given the significant morbidity rate associated with Alzheimer’s disease such as agitation, apathy, sleep disturbances and anxiety, it became clear to us that novel approaches to treat Alzheimer’s-type cognitive impairment are urgently needed. The Phase II clinical trial will test Biomind’s psychiatry intervention-based model, allowing a rapid and feasible merge of fast-acting psychedelic medicines into clinical practices already in existence,” Antalich said.

An analysis of molecules that might help with depression and anxiety in Alzheimer’s led company scientists to conclude “the most suitable candidate from our portfolio was BMND08, an oral formulation of 5-MeO-DMT,” Antalich added.

According to the press release, the trial will be led by Martín A. Bruno, a neuroscientist and the director of the at the Instituto de Ciencias Biomédicas, Universidad Católica de Cuyo, in Argentina.

Biomind, based in Toronto, reported that the previous Phase 2 trials of N, N-dimethyltryptamine, or DMT, for the treatment-resistant depression and held in Brazil tested intramuscular and inhaled formulations of DMT, respectively. Safety and tolerability were found in the first study, the company announced in March.