3D rendering representing interaction between brain neurons
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Clinical-stage biopharma company Cyclerion Therapeutics and artificial intelligence (AI) drug developer Ariana Pharma announced on Wednesday a collaboration to identify biomarkers of therapeutic response aimed at boosting Cyclerion’s investigational therapeutics program in neurological and neuropsychiatric diseases associated with cognitive impairment leveraging Ariana’s AI technology.

“Ariana integrates disease biology, mechanism information, and pre/clinical data in their AI platform. This multidimensional machine learning approach, based on Formal Concept Analysis, identifies all possible relationships, the strongest of which may form the basis of drug-specific patient selection and/or surrogate pharmacology/efficacy markers and identify additional indications, said Andy Busch, CSO of Cyclerion Therapeutics in a press release. “We believe that Ariana’s extensive drug development experience in the CNS and the application of this technology to our innovative pipeline may be quite powerful in guiding efficient drug development, and we look forward to a productive collaboration focused on successfully advancing CY6463 for diseases associated with cognitive impairment.”

The initial focus of the collaboration will be to support the development of CY6463, Cyclerion’s lead clinical program. CY6463 is a first-in-class, central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator for neurological and neuropsychiatric diseases associated with cognitive impairment. sGC stimulators have already been approved as medications for the treatment of heart failure and pulmonary arterial hypertension. For these indications, they promote vasodilation and inhibit smooth muscle proliferation, leukocyte recruitment, platelet aggregation, and vascular remodeling via a number of resultant downstream mechanisms.

CY6463 was designed to address multiple pathophysiological features of these disorders. The collaboration will analyze data from completed Phase I clinical studies of CY6463, including a completed translational pharmacology study in healthy elderly subjects, as well as an ongoing study in Cognitive Impairment Associated with Schizophrenia (CIAS). Insights from these analyses are expected to accelerate and support further clinical development of CY6463

Ariana Pharma’s proprietary KEM® (Knowledge Extraction and Management) eXplainable Artificial Intelligence (xAI) technology will be used to accelerate the clinical development timelines for CY6463—and other future clinical candidates—by evaluating complex clinical data, including the discovery of hidden pharmacological and efficacy signals that may be beyond the reach of conventional statistical analyses. The aim is to identify specific populations that will respond to a targeted therapeutic, while also developing biomarkers that demonstrate therapeutic response to inform future clinical research.

“We are eager to apply our pioneering eXplainable AI platform KEM® to support the development of Cyclerion’s promising therapeutic candidates,” said Mohammad Afshar, CEO of Ariana Pharma. “We believe that our platform has the capacity to help guide the selection of patients who may benefit most from the therapy, by identifying patient-selection biomarkers, and the right measure of therapeutic efficacy, by identifying pharmacodynamic biomarkers, and optimal endpoints for future clinical development. We are excited about the prospect of using our xAI to accelerate the precision medicine development of CY6463 towards effective treatments against devastating neurological and neuropsychiatric diseases.”

In addition to the ongoing study in CIAS, studies to evaluate CY6463 safety and signals of clinical activity are also active in participants with Alzheimer’s Disease with vascular pathology (ADv); and Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). Cyclerion expects to obtain clinical results from the MELAS and CIAS studies in Q2 2022 and 2H 2022, respectively. The ADv study initiated patient dosing in January 2022 and enrollment is ongoing.

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