New preclinical data demonstrate dose dependent positive impact on reversal of pulmonary vascular remodeling by Cereno Scientific’s novel HDACi CS014

Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech developing innovative treatments for rare and common cardiovascular disease, today announced new preclinical data that demonstrates dose dependent reversal of pulmonary vascular remodeling by Cereno’s HDAC inhibitor CS014.

CS014, having recently entered a Phase I trial in healthy volunteers in June 2024, is a novel histone deacetylase (HDAC) inhibitor being developed by Cereno. CS014 is, together with lead compound CS1 part of Cereno’s HDACi program which capitalizes on the principle of epigenetic modulation. 

Studies of CS014 were conducted in a well-established preclinical model of Pulmonary Arterial Hypertension (PAH). This model exhibits many features in common with the clinical disease, including pulmonary vascular remodeling and fibrosis. Importantly, the model also exhibits so called “plexiform lesions”, a pathophysiological hallmark feature of PAH.

The study demonstrated that CS014 induced a robust, dose dependent reversal of the pulmonary vascular remodeling in this preclinical PAH model. This included statistically significant reductions in small artery vessel occlusion, plexiform lesions and small vessel related fibrosis.

Overall, these preclinical data provide the most compelling evidence to date that CS014 offers a disease modifying approach to PAH and related pulmonary vascular diseases by robustly reversing pulmonary pathological vascular remodeling and fibrosis.

Further study details and results will be shared in a future scientific publication.

 

“The CS014 effects in the preclinical model are impressive and give us a very good basis to target diseases of vascular remodeling and fibrosis in future clinical trials”, said Nicholas Oakes, Head of Preclinical Development, Cereno Scientific.

 

“I am happy to share progress in our HDAC inhibitor program, adding to the plethora of evidence supporting the concept of HDAC inhibition and epigenetic modulation as relevant approaches for disease modifying therapies in cardiovascular diseases“ , said Sten. R. Sörensen, CEO, Cereno Scientific.

 

About Cereno’s HDAC Inhibitor Program

HDACs (histone deacetylase) are a class of enzymes that are one of the most common epigenetic modulators. Cereno Scientific is one of the first to develop HDAC inhibition for cardiovascular disease (CVD) through the application of epigenetic modulation; which can be described as changing gene expression without changing the genetic code. This provides the opportunity to develop safer and more effective treatments for CVD’s with a completely new mode of action.

 

Cereno’s HDAC inhibitor program, capitalizing on the principle of epigenetic modulation, comprises Cereno’s lead drug candidate CS1 and the investigational drug candidate CS014.

 

About the novel HDACi CS014

CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator – regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. HDAC inhibition as a therapy to avoid thrombosis could fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. The drug candidate has also demonstrated a favorable profile in preclinical models of other cardiovascular diseases, such as PAH, with reverse remodeling of pulmonary arterial vessels and effects on vascular fibrosis. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular remodeling and elevated blood pressure.

 

For further information, please contact:

Henrik Westdahl, Director IR & Communications

Email: [email protected]

Phone: +46 70-817 59 96

 

Sten R. Sörensen, CEO

Email: [email protected]

Phone: +46 73-374 03 74

 

About Cereno Scientific AB

Cereno Scientific develops innovative treatments for rare and common 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 trial is ongoing (patient recruitment closed on July 1st, 2024) to evaluate CS1’s safety, tolerability, and exploratory efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). The study will also provide insights for planning the subsequent trial of CS1 in PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the trial. Two initiatives performed during the Phase II trial 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 trial 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’s pipeline comprises two additional programs in development through research collaborations with the University of Michigan. Investigational drug CS014 is an HDAC inhibitor in Phase I development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment. 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 an increased risk of bleeding as documented in preclinical trials. The drug candidate has also demonstrated a favorable profile in preclinical models of other cardiovascular diseases, such as PAH, with reverse remodeling of pulmonary arterial vessels and effects on vascular fibrosis. On 28th of June, 2024, Cereno initiated a first-in-human Phase I trial of CS014. Preclinical candidate CS585 is an oral, highly potent and selective IP receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. 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. CS585 was in-licensed from the University of Michigan in 2023. 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 is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, [email protected]. More information is on www.cerenoscientific.com.