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 that an oral presentation titled “Exploratory outcomes of CS1 in Pulmonary Arterial Hypertension: Phase 2A, Prospective, Randomized, Open-Label, Multicenter Trial” was presented at the 5th Baltic Pulmonary Hypertension Conference 2025 on May 9, 2025, in Kaunas, Lithuania.
The data presented in an abstract at the Baltic PH Conference highlighted key results from the Phase IIa trial of CS1 in PAH. The primary endpoint of safety and tolerability was met without any drug-related safety concerns. After 12 weeks, REVEAL Risk Score 2.0 was improved from baseline in 40.9% of patients and stable in a further 31.8% of patients. A total of 31.8% and 54.5% of patients improved or maintained their NYHA/WHO functional class, respectively. The majority of patients (71%) showed an improvement in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The abstract concludes that the findings from the Phase IIa trial suggest that treatment with CS1 in patients with pulmonary arterial hypertension (PAH) improve risk score, functional class and quality of life. The conclusion states that CS1 warrants further study. Tatiane Abreu Dall’Agnol, Medical Director at Cereno Scientific, presented the abstract at the conference.
“I am pleased that we have now presented the results from our Phase IIa trial of CS1 in PAH to the scientific community in a formal setting. The Phase IIa trial demonstrated that CS1 is well-tolerated and has a favorable safety profile. Importantly, we observed encouraging signals of reverse vascular remodeling. These exploratory efficacy findings are promising and we are now planning a larger, placebo-controlled Phase IIb trial in PAH to further evaluate these effects,” said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific.
“There remains a profound unmet need in PAH for treatments that do more than just manage symptoms. With CS1, we are developing a potential first-in-class, disease-modifying therapy that targets the root mechanisms driving PAH — pathological vascular remodeling and right heart dysfunction. The favorable safety and tolerability profile, along with encouraging efficacy signals observed in our clinical development to date, reinforce CS1’s potential to transform how PAH is treated. We are proud to continue advancing this innovation with the goal of meaningfully improving the lives of patients living with this devastating disease,” said Sten R. Sörensen, CEO of Cereno Scientific.
A publication of the Phase IIa trial results of CS1 in PAH is in development with the aim be published during H2 2025.
Abstract details:
Benza, R., et al. (2025). Exploratory outcomes of CS1 in pulmonary arterial hypertension: Phase 2A, prospective, randomized, open-label, multicenter trial Raymond [Abstract]. Abstracts book of the 5th Baltic Pulmonary Hypertension Conference 2025, Kaunas, Lithuania.
For further information, please contact:
Tove Bergenholt, Head of IR & Communications
Email: tove.bergenholt@cerenoscientific.com
Phone: +46 73- 236 62 46
Sten R. Sörensen, CEO
Email: sten.sorensen@cerenoscientific.com
Phone: +46 73-374 03 74
About Cereno Scientific AB
Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full.
Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as an effective and disease modifying treatment with a favorable safety and tolerability profile for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 has a favorable safety profile, is well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension.
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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