“This is the first issued patent in India for our CS1 patent portfolio, which strengthens the drug candidate’s global IPR. India is a major pharmaceutical market and is a valuable addition to our patent portfolio. The expansion of CS1's patent portfolio plays a crucial role in shaping its forthcoming commercial strategy, which will be bolstered by robust clinical data,” said Sten R. Sörensen, CEO at Cereno Scientific.

 

CS1’s third patent family is titled “Delayed Release Pharmaceutical Formulations Comprising Valproic Acid, and Uses Thereof.” The patent number assigned is 447709, and the patent will be valid through 2037. Previously, the third patent family has obtained granted patents in Israel, Japan, Mexico, Australia, Russia and the US.

 

Drug candidate CS1 is currently being evaluated in a Phase II study in PAH. The study is actively recruiting patients at 9 specialist clinics in the US, and two additional new clinics are in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiac output. The patient’s overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. Currently, a request for expanded access to CS1 (also called “compassionate use”) is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in Q2 2024.

 

 

For further information, please contact:

Tove Bergenholt, Director IR & Communications

Email: tove.bergenholt@cerenoscientific.com

Phone: +46 732-366 246

 

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 an 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 Q2 2024. Cereno also has two promising preclinical drug candidates in development through research collaborations with the University of Michigan. Investigational drug CS014 is an 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 preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding. 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.