Home News Cereno builds momentum for major clinical milestones

Cereno builds momentum for major clinical milestones

Cereno builds momentum for major clinical milestones

19 May, 2023

Cereno Scientific has announced making strong progress with its phase II clinical study with lead drug candidate CS1. The study, run in patients with pulmonary arterial hypertension, is part of Cereno’s efforts to develop new and better treatments for patients suffering from common and rare cardiovascular disease. To continue pursuing this vision, the company is raising capital through a rights issue of approximately 110 million SEK.  

This material has been prepared for marketing purposes and is not and should not be considered a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and more information about the company have been presented in the EU Growth Prospectus published at cerenoscientific.com on 5 May 2023.

Cardiovascular disease is the number one cause of death globally, killing nearly twice as many people as cancer. The term includes all diseases that involve the heart and/or the blood vessels. A majority of the complications associated with cardiovascular disease are caused by blood clots. These blockages in the blood vessels can lead to heart attacks, secondary heart failure, cardiac arrhythmias, stroke, among other severe complications.

Cereno Scientific’s goal is to develop innovative treatments to prolong life and improve quality of life for people with common and rare cardiovascular disease. The company’s lead drug candidate CS1 caught the eyes of the FDA in 2020 when it was granted Orphan Drug Designation for the treatment of the rare cardiovascular disease pulmonary arterial hypertension (PAH).

In preclinical PAH models, CS1 showed multi-fold efficacy, including pulmonary pressure reducing, “reverse-remodeling”, anti-fibrotic, anti-inflammatory, and anti-thrombotic properties. The decision from FDA was a sign that the American regulators strongly believe that the drug candidate has the potential to provide significant benefit to PAH patients.

Dr Raymond Benza, a global PAH key opinion leader and Principal Investigator for the phase II study is also confident in CS1’s potential:

“CS1 has to definitely be tested in PAH – it could be game-changing for patients.”

Phase II study with CS1

Since the FDA’s decision, CS1 has reached phase II in the clinic. The study is being run in collaboration with the global healthcare company Abbott, who is providing its CardioMEMS HF System technology for daily pulmonary pressure measurements during the study period.

Despite an initial delay in patient recruitment caused by the pandemic, the phase II study is progressing steadily. In February, Cereno reported that all nine of the selected clinical study sites in the US had been activated. Since then, the pre-screening process has started in all centres, thus identifying several eligible patients for the study.

Recently, Cereno announced that 16 patients have been enrolled, with nine having received implantation with Abbot’s CardioMEMS HF System. Five patients have been randomized and are in active treatment, while two patients have completed the study.

According to Cereno’s CEO Sten R Sörensen in a recent interview with BioStock, recruitment of the 30 PAH patients to be included in the study is on track. Furthermore, the phase II study’s top-line results are expected at the end of the year, bringing Cereno closer to potentially being able to offer PAH patients a new disease-modifying treatment.

Cereno’s CMO Björn Dahlöf was delighted about the active recruitment process:

“I am pleased that we are seeing continuous progress in the Phase II study with CS1 in PAH. I look forward to following the progress with more and more patients completing each of the different steps towards the completion of the study and analysis of the study results.”

Raising capital for project advancements

The recent milestones reached with CS1 are a mark of significant progress for Cereno as it advances its ambition to develop new and better treatments in cardiovascular disease.

To continue a timely pace of development with CS1 and reach new important milestones, the company has set out to secure additional capital. Through a preferential rights, the company will raise approximately 110 million SEK before transaction costs.

Watch Sten R. Sörensen, CEO, and Björn Dahlöf, CMO, in an interview on the rights issue here.

Tune in to see Sten R. Sörensen presenting the company here.

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