Psilera's psilocybin drug could treat frontotemporal dementia without psychoactive effects

Psileraa Tampa-based biotech company, has taken a significant step toward advancing dementia treatment with its psilocybin-based drug. PSIL-006Unlike traditional psychedelics, this pharmaceutical version of psilocybin is designed to avoid the hallucinogenic effects commonly associated with “magic mushrooms,” paving the way for more accessible therapies.

The company recently announced that PSIL-006 had achieved a major safety milestone in preclinical studies, demonstrating a “strong” safety profile. This progress is an important step toward future human trials and potentially FDA approval. If successful, the drug could Frontotemporal dementia (FTD)a disease that affects nearly 60 million Americans and for which there is currently no FDA-approved treatment.

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Improving dementia treatment without psychedelic effects

Psilera's PSIL-006 has been tested in models mimicking FTD and has shown promising improvements in memory, sleep and learning ability. However, more research and rigorous clinical trials, including human testing, are needed before the drug can be considered for FDA approval.

What makes PSIL-006 unique in the field of psychedelic-based treatments is its trip-free design. Traditional psychedelics such as MDMA, LSD and psilocybin have been difficult to study in double-blind placebo trials due to their powerful effects, which make it obvious to both patients and researchers whether they have received the real drug or a placebo. This limitation has long hampered their progress through the clinical approval process.

Because PSIL-006 does not have the typical “trip” or any psychoactive effects of psilocybin, it could allow for more reliable double-blind trials, a key element for FDA approval. The drug is designed to provide the therapeutic benefits of psilocybin without the mind-altering experiences, making it safer and more practical for patients with mental disorders or dementia who might otherwise experience confusion or anxiety during a psychedelic trip.

A new frontier in psychedelic medicine

As Double Blind reported, the development of non-psychedelic versions of drugs like psilocybin is gaining momentum. Other companies, such as Boston-based Onsero Therapeutics And Delix Therapeutics are also working on trip-free psychedelic drugs. These compounds target the 5-HT2A receptor, the same receptor that is affected by psychedelics, without causing hallucinations. Aaron KoenigChief medical officer at Delix Therapeutics, told Scientific American: “Some patients are terrified of these trips and never want to do it again.”

The development of trip-free versions of these drugs offers additional benefits, including the ability to self-administer at home rather than under medical supervision. This could make treatment more accessible and convenient, particularly for long-term or chronic conditions such as dementia.

The future of non-psychedelic therapies

While the therapeutic potential of psychedelic drugs is well documented, the focus on developing non-psychedelic derivatives has opened up new treatment options. These innovations are being closely watched in a multi-billion dollar industry driven by growing demand for mental health therapies. As clinical trials progress, PSIL-006 and other non-psychedelic therapies could significantly impact the future of mental health and dementia treatment, filling a pressing need in the U.S., where mental health issues affect approximately 60 million people.

Cover image created with Ai