Cereno Scientific announces new patent issued in 25 European countries for Phase II drug candidate CS1

"I am pleased to announce that our leading drug candidate CS1 has obtained a patent issued by the European Patent Office, valid in 25 European countries. This expanded patent protection, encompassing leading European pharmaceutical markets, marks yet another milestone for CS1 and is an important component is our positioning and commercial strategy for CS1," says Sten R. Sörensen, CEO at Cereno Scientific.

The granted European patent for Cereno's third family, related to drug candidate CS1, is titled "Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof". The patent has been given patent number EP3439649 by the European Patent Office and will be valid through 2037 with the possibility of patent extension of up to five years. The third patent family for CS1 has previously been issued in the US, Japan, Mexico, Australia, India, Russia and Israel.

Cereno Scientific has during the last few months reported positive findings from the ongoing study suggesting a potential positive clinical benefit of drug candidate CS1 in patients with the severe rare disease PAH. Study completion and topline results are expected during Q3 2024. On January 30, Cereno was granted approval by the FDA for Expanded Access, sometimes called "Compassionate Use", to investigational drug CS1 for use in an extension of the ongoing Phase II trial evaluating CS1 in pulmonary arterial hypertension (PAH). This is an important milestone on our path toward making a difference for patients with the deadly rare disease PAH.

 

For further information, please contact:

Henrik Westdahl, Director IR & Communications

Email: henrik.westdahl@cerenoscientific.com

Phone: +46 70-817 59 96

 

Sten R. Sörensen, CEO

Email: sten.sorensen@cerenoscientific.com

Phone: +46 73-374 03 74

 

About Cereno Scientific AB

Cereno Scientific develops innovative treatments for common and rare cardiovascular disease. The lead drug candidate, CS1, is a HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase II study is ongoing to evaluate CS1's safety, tolerability, and efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Two initiatives performed during the ongoing Phase II study have shown positive findings suggesting the potential clinical benefit of CS1 in PAH patients. These initial findings are, however, not a guarantee of the final study results that are expected in Q3 2024. Since January 2024, we are delighted that the FDA's Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno also has two promising preclinical drug candidates in development through research collaborations with the University of Michigan. Investigational drug CS014 is a HDAC inhibitor in development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment potentially without the associated increased risk of bleeding in humans. CS014 is a new chemical entity with a multi-fold mechanism of action as an epigenetic modulator - regulating platelet activity, fibrinolysis, and clot stability for the prevention of thrombosis without increased risk of bleeding as documented in preclinical studies. Drug candidate CS585 is a prostacyclin receptor agonist that has been documented in several preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding, which also has been recognized in the medical community. CS585 was in-licensed from the University of Michigan in 2023. The company is headquartered in Gothenburg, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). More information on www.cerenoscientific.com.

Datum 2024-03-22, kl 08:30
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