Rhelion Life Sciences' Wholly Owned Subsidiary Filament Health Signs Letter of Intent with Darmiyan, Inc. to Explore Use of FDA De Novo Authorized BrainSee(R) AI Platform in Early Alzheimer's Disease Trial Design

Collaboration looks to explore the use of Darmiyan's FDA De Novo authorized BrainSee® imaging platform, authorized for predicting risk of progression to Alzheimer's disease in patients with amnestic mild cognitive impairment, as well as Darmiyan's core technology, the Virtual Microscope, tailored towards use in pharmaceutical clinical trials

The goal of the collaboration is to inform the identification, selection and monitoring of the best candidates for clinical trials of PEX010, Rhelion's patented, naturally derived psilocybin drug candidate

Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX) (OTCQB: TRUFF) ("Rhelion" or the "Company"), an Ontario-based organization advancing innovation and research within the legal psychedelic sector, is pleased to announce that its wholly owned subsidiary, Filament Health Corp. ("Filament"), has entered into a non-binding letter of intent (the "LOI") with Darmiyan, Inc. ("Darmiyan"), a San Francisco based brain technology company, to explore a collaboration combining Darmiyan's artificial intelligence brain imaging platform with PEX010, Filament's patented, standardized, GMP manufactured natural psilocybin drug candidate.

Darmiyan is the developer of BrainSee, which in January 2024 received marketing authorization from the U.S. Food and Drug Administration ("FDA") through the De Novo pathway, following the granting of FDA Breakthrough Device Designation in 2021.

Darmiyan is a graduate of the Y Combinator accelerator program (S17) and counts Y Combinator, Eisai Co., Ltd., the co-developer of Leqembi, and IT-Farm Corporation among its investors.

The De Novo pathway is the FDA route for novel, first-of-their-kind medical devices that carry low to moderate risk but have no legally marketed earlier device, known as a predicate, against which they can be compared.

It allows a device to obtain marketing authorization on the strength of its own safety and effectiveness evidence, rather than through the far heavier premarket approval process reserved for high risk devices.

A granted De Novo also creates a new device classification, establishing the predicate that subsequent products in the category must be measured against.

BrainSee combines a standard, non-contrast brain MRI with routine cognitive assessments to generate a prognostic score indicating the likelihood that a patient aged 55 or older with amnestic mild cognitive impairment ("aMCI") will progress to Alzheimer's dementia within five years.

aMCI is an early stage of cognitive decline in which memory difficulties are measurable and noticeable to the individual and their family, but daily independence is preserved.

Darmiyan's platform takes a whole-brain, microstructural view of tissue health rather than relying on a single pathological marker, and the Company believes this holistic approach is well suited to the study of agents that may act on brain plasticity and network function.

Under the LOI, the parties intend to explore the potential of applying Darmiyan's technology to improve the design of a possible future clinical study of PEX010 in individuals with early cognitive impairment who are at elevated risk of progression to Alzheimer's disease.

The Company believes that AI-enabled patient selection has the potential to meaningfully reduce the number of participants, the duration, and therefore the cost of clinical research in this therapeutic area, while increasing the likelihood of detecting a treatment effect if one is present.

The parties also intend to explore the use of Darmiyan's voxel-based quantitative imaging outputs as exploratory measures of biological change.

PEX010 has been selected as the investigational drug product for more than 80 academic and philanthropic research studies worldwide.

"There is a growing body of preclinical evidence that psilocybin acts as a neuroplastogen, promoting the growth and reorganization of connections between neurons," said Shashkes...