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Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
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 the company has completed a Type C meeting with the U.S. Food and Drug Administration (FDA). The intention was to seek advice from the FDA to finalize the Phase IIb trial design and align on further clinical development steps for CS1 based on the encouraging signals suggesting reverse vascular remodeling effects observed in the Phase IIa trial. The discussions during the meeting indicate alignment between the FDA and Cereno Scientific on the plans. An update on the CS1 program will be shared following receipt of the official meeting minutes.
"We had a productive discussion with the FDA regarding the further clinical development of our promising HDAC inhibitor CS1. The team at the FDA have extensive experience in clinical trials and what is needed for marketing authorizations, so it is very important to utilize the meeting time optimally ensuring that our questions are answered. I am very pleased with the discussions and look forward to receiving the official meeting minutes as an immediate next step for the development program," said Rahul Agrawal, CMO and Head of R&D, Cereno Scientific.
The FDA Type C meeting that was held on April 21, 2025, focused on finalizing the design of the Phase IIb trial and aligning on further clinical development steps. Cereno Scientific plans to give an update on CS1's development program following receipt of the official meeting minutes, which are expected approximately one month after the meeting.
"It is a sound strategy to seek advice from the authorities several times during the clinical development of a drug candidate to ensure that expectations are aligned from both parties. Our interactions with the FDA for the lead program CS1 have been insightful, starting with meetings prior to the Phase IIa trial, the orphan drug designation (ODD), the Extended Access Program (EAP) and now the Type C meeting in preparation for our Phase IIb trial. We look forward to continuing to advance an innovative treatment for people with the severe rare disease PAH," said Sten R. Sörensen, CEO of Cereno Scientific.
Drug candidate CS1 is an epigenetic modulating HDACi that aims to improve quality of life and extend life expectancy for patients with the rare disease pulmonary arterial hypertension (PAH). A Phase IIa trial showed that CS1 has a favorable safety profile and is well-tolerated as a treatment for people with pulmonary arterial hypertension (PAH). The trial showed efficacy signals suggesting reverse vascular remodeling effects of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and prognosis. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.
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 Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com.