As Cereno Scientific prepares to initiate its phase II trial with candidate CS1 in rare cardiovascular disease Pulmonary Arterial Hypertension, the company is taking the opportunity to participate in the CVCT Forum – an event that brings together Key Opinion Leaders within the field. BioStock reached out Cereno’s CMO Dr Björn Dahlöf as well as the forum’s chair and cofounder, Dr Faiez Zannad, to hear more about the overall importance of the Forum, how Cereno is contributing at the event, and what Cereno will gain from participating.
This year’s prestigious Global CardioVascular Clinical Trialists (CVCT) Forum is underway. The virtual event brings together global cardiovascular disease (CVD) experts, including scientists, major industry players, CROs, prestigious research institutions, regulatory agencies, patient representatives and many others, for four days of discussions about the latest within clinical trials in the CVD space.
Cereno Scientific working with CVD leaders
Swedish biotech Cereno Scientific who develops treatments for common and rare CVDs, is participating at the Forum with a presentation by Chief Medical Officer Björn Dahlöf during a session called “The Evolving Landscape Of Pulmonary Arterial Hypertension Phase 3 Trials Part 2- Redefining Clinically Meaningful Endpoints.” Dr Dahlöf will provide his input on this topic from an industry perspective alongside representatives from global life science players Merck and Abbott, with the latter being one of Cereno’s key collaborators. See the full CVCT programme here.
The company is working closely with some of the main Key Opinion Leaders (KOLs) involved in CVCT through its Scientific Advisory Board (SAB). This includes the Forum’s founders and co-chairs, Dr Faiez Zannad and Dr Bertram Pitt.
»I have been part of the CVCT community for several years in my capacity as Principal Investigator of major mortality and morbidity studies in cardiovascular disease prevention. Now, being CMO of Cereno Scientific brings another interesting dimension to cardiovascular trials and I also have the privilege to present our innovative phase II trial to the community. The gain [from the CVCT Forum] for me and the company will be the interaction and networking with leading thought leaders from all aspects of cardiovascular trials, gaining further knowledge and inspiration, and putting our phase II trial in context of the evolving field of PAH therapy and trials.« — Dr Björn Dahlöf, CMO at Cereno Scientific
Another KOL present at the Forum, and who is also member of Cereno’s SAB, is Dr Raymond Benza. Dr Benza is a global thought leader within Pulmonary Arterial Hypertension (PAH), which happens to be Cereno’s focus indication for lead candidate CS1. In fact, after receiving Investigational New Drug (IND) acceptance from the FDA, the company recently initiated a phase II clinical trial of CS1 in PAH.
The trial uses a novel treatment approach in PAH with epigenetic modulation through HDAC (Histone DeACetylase) inhibition, and Cereno has implemented a clinical trial design that includes a number of secondary exploratory objectives. Furthermore, through the aforementioned collaboration with Abbott, the CardioMEMS HF System, a pulmonary artery pressure monitoring device, will be used in the trial. The device has already been proven to significantly reduce heart failure hospital admissions, and the phase II study with CS1 will be the first time the device is used in a PAH clinical trial.
Dr Benza has been an instrumental advisor to Cereno when planning the clinical aspects of the phase II study and is the Principal Investigator for the trial. Read more about Cereno’s SAB including a profile of Dr Benza here.
KOLs help position Cereno in the industry
Having a close relationship with top KOLs such as Dr Zannad, Dr Pitt and Dr Benza gives Cereno Scientific credibility within the CVD field. This is a key value driver for the company, especially as it enters a new phase of clinical development with CS1, while also expanding its development programme with additional candidates with potential in other CVD indications. Read more here.
Learning more from the experts
BioStock wanted to learn more about the importance of attending the CVCT Forum for Cereno and having such a close partnership with leading CVD KOLs, especially considering the company’s continued growth, both within the team and within its clinical development programme. So, we reached out to the company’s CMO, Dr Björn Dahlöf, as well as the CVCT’s Chair and cofounder Dr Zannad.
»The key purpose of the Global CVCT Forum is to bring together expert stakeholders from various backgrounds to discuss key recent and future clinical trials within cardiovascular, cardiorenal and cardiometabolic diseases in depth, both individually and in context. CVCT is the only global meeting that brings together the most authoritative stakeholders to discuss clinical trials in detail and I am very much looking forward to this year’s edition. You can almost say that the CVCT Forum a gathering of “Who is Who” within cardiovascular diseases.« — Dr Faiez Zannad, member of Cereno Scientific’s SAB and co-chair of the CVCT Forum
Dr Dahlöf, Cereno is once again attending the CVCT Forum where CVD clinical trials come front and centre. What will the company gain the most from attending this year?
– I have been part of the CVCT community for several years in my capacity as Principal Investigator of major mortality and morbidity studies in cardiovascular disease prevention. Now, being CMO of Cereno Scientific brings another interesting dimension to cardiovascular trials and I also have the privilege to present our innovative phase II trial to the community. The gain for me and the company will be the interaction and networking with leading thought leaders from all aspects of cardiovascular trials, gaining further knowledge and inspiration, and putting our phase II trial in context of the evolving field of PAH therapy and trials.
You will be contributing at CVCT with a presentation alongside representatives from Merck and Abbott. What will this presentation focus on?
– My presentation will focus on the innovative and cost-effective design of our phase II trial in PAH, which is of utmost importance for future development of CS1 with Cereno being a small biotech company. Firstly, I will introduce the key features of the CS1 PAH program with a focus on the potential of epigenetic modulation in PAH, the smart formulation of CS1 and the unique combination of CS1’s four efficacy pillars which are anti-proliferation/anti-fibrosis, anti-inflammation, pulmonary pressure reduction and anti-thrombosis. Secondly, I will highlight other key elements of the trial including remote monitoring of pulmonary pressure by the CardioMEMS technique in collaboration with Abbott and the long list of secondary exploratory objectives. In combination, we hope to have all we need for the next clinical trial, including safety and tolerability which is the primary objective of the phase II trial, the right dose(s), exploratory efficacy, and pharmacokinetics.
The company is currently searching for a Head of Clinical Development and a Head of Research and Preclinical Development. What are the overall implications of these additions?
– Yes, we have recently experienced rapid growth with an expanded pipeline and the initiation of our first phase II program. To support this, as well as the future growth of the company, we are continuously assessing the need to build out our organization. We have already strengthened our team with key roles within clinical trial execution and are currently looking for additional experts to lead our clinical research as well as preclinical development work. The new additions will enable us to successfully deliver on the ongoing development programs as they continue to progress, together with our collaboration partners.
Dr Zannad, as chair of CVCT, what is the main goal of the Forum?
– The key purpose of the Global CVCT Forum is to bring together expert stakeholders from various backgrounds to discuss key recent and future clinical trials within cardiovascular, cardiorenal and cardiometabolic diseases in depth, both individually and in context. CVCT is the only global meeting that brings together the most authoritative stakeholders to discuss clinical trials in detail and I am very much looking forward to this year’s edition. You can almost say that the CVCT Forum a gathering of “Who is Who” within CV.
And as a member of Cereno’s SAB, how do you hope this year’s Forum will contribute to the company’s clinical development?
– I hope that Cereno will be able to both connect with, and take inspiration from, all the other stakeholders present at the CVCT and gain an expanded view on the different elements of clinical development. I am also looking forward to Cereno’s contributions to the sessions focused on the evolving landscape of PAH trials. I think it will be interesting for the community to learn more about the innovative elements of their phase II trial.
Finally, what are your expectations for Cereno’s phase II trial within PAH?
– It has been a pleasure to follow Cereno’s journey so far, and I am impressed with the progress made by the team up to this point. CS1 is showing promising characteristics that fit very well with the pathogenesis of PAH, so I am excited to see the clinical evidence as it unfolds.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.