Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced plans to initiate preclinical disease model studies evaluating its drug candidate CS585 in antiphospholipid syndrome (APS), a rare autoimmune disease associated with recurrent blood clots and serious cardiovascular complications. This is an important next step in the development of CS585 toward rare thrombotic diseases with high unmet medical need, supporting future clinical development planning.

CS585 is a novel, potent and selective prostacyclin receptor agonist (IP receptor agonist) in preclinical development targeting rare thrombotic diseases with significant unmet medical need. In preclinical studies conducted to date, CS585 has demonstrated the ability to prevent thrombosis without increasing bleeding risk and exhibit a long-lasting effect of more than 24 hours. This is a highly differentiated profile compared to currently available antithrombotic therapies. The planned APS-focused studies are intended to further evaluate CS585’s therapeutic potential in a disease characterized by recurrent thrombosis and limited treatment options. The studies will be led by Professor Michael Holinstat, Director of Translational Research at Cereno Scientific and Professor at the University of Michigan.

“CS585 has consistently demonstrated compelling antithrombotic effects in preclinical studies while preserving normal hemostasis, which is a highly desirable profile in thrombotic disease,” said Mike Holinstat, Director of Translational Research at Cereno Scientific and Professor at the University of Michigan. “APS represents a scientifically and clinically relevant disease model for further evaluating the candidate’s therapeutic potential and to progress toward clinical phase.”

APS is a rare autoimmune disorder in which the immune system mistakenly produces antibodies that increase the risk of blood clot formation. Patients with APS face elevated risk of deep vein thrombosis, stroke, pulmonary embolism, pregnancy-related complications, and organ damage. Current standard-of-care treatment primarily relies on chronic anticoagulation therapy, which may reduce thrombotic risk but can also significantly increase bleeding risk and require burdensome long-term monitoring.

“Advancing CS585 into disease models of APS marks continued progress for Cereno Scientific as we expand our pipeline of innovative therapies for rare cardiovascular diseases,” said Sten R. Sörensen, CEO of Cereno Scientific. “The market for safer and more effective long-term antithrombotic therapies in rare thrombotic diseases remains highly underserved, creating a significant opportunity for CS585.”

The preclinical APS studies are planned to be initiated during 2026 through Cereno Scientific’s ongoing research collaboration with the University of Michigan. The data generated are expected to support future development planning and continued evaluation of CS585 toward clinical development.

For further information, please contact:
Tove Bergenholt, Head of IR & Communications
Email: tove.bergenholt@cerenoscientific.com
Phone: +46 73- 236 62 46

About Cereno Scientific AB
Cereno Scientific is pioneering treatments to enhance and extend life. The company’s innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest.

Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the root mechanisms of the pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals in a Phase IIa trial in patients with PAH, including improvements in right heart function, functional class and patient quality of life, with early signs consistent with reverse vascular remodeling. An Expanded Access Program confirmed CS1 to be well-tolerated with a favorable safety profile over 12-months treatment. CS014 is a new chemical entity and HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of a range of cardiovascular and pulmonary diseases with high unmet needs. CS014 showed favorable safety and tolerability profile in Phase I, development focus for Phase II is pulmonary hypertension associated with interstitial lung disease (PH-ILD). Cereno Scientific is also advancing the preclinical program CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist shown to prevent thrombosis without increased bleeding risk, currently being evaluated in antiphospholipid syndrome (APS).

The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com.

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