In 2021, focused Cereno Scientifics activities to pave the way for the start of a Phase II clinical study with the company's lead candidate CS1CS1 is a novel formulation of a histone deacetylase inhibitor (HDACi) called valproic acid (VPA), which has shown potential to treat a broad spectrum of cardiovascular diseases (CVD) due to its anti-thrombotic, anti-inflammatory, anti-fibrotic and pressure-reducing properties. This treatment strategy, based on epigenetic modulation, represents a novel approach in CVD therapy.
Initiates Phase II with CS1
In March 2020, the FDA Orphan Drug Designation (ODD) for CS1 as a treatment for the rare CVD disease pulmonary arterial hypertension (PAH). In early 2021, a collaboration with the global contract research organization (CRO) was initiated. Worldwide Clinical Trials to plan and conduct the phase II study
In August, Cereno began a collaboration with the global healthcare company Abbott to use their pulmonary artery pressure monitoring system CardioMEMS HF System in the study. In collaboration with Abbott and Worldwide Clinical Trials, a Investigational New Drug (IND) to the FDA, who approved the application in september.
Dr Raymond Benza, highly regarded within PAH and part of Cereno's Scientific Advisory Board (SAB), has taken on the role of principal investigator in the phase II study.
»I have been looking forward to new clinical trials in PAH ever since I started working with Cereno and CS1 in the spring of 2020. With this drug's unique mechanism of action, I believe CS1 has the potential to change the game for treating PAH patients.« — Dr. Raymond Benza
Strengthened preclinical pipeline
In 2021, Cereno took several steps to further strengthen its development portfolio in common and rare CVD. In collaboration with University of Michigan under the leadership of Dr. Michael Holinstat, Cereno is now conducting two preclinical development programs; CS585 and CS014.
CS014 was originally acquired from Emeriti Bio 2019 and subsequently further developed in a collaboration between the two companies. It is an HDACi and is Cereno's second epigenetic modulation program contributing to the ongoing development of CS1. The CS585 program consists of small molecule analogs of the endogenous metabolite 12-HETrE. The program consists of selective, potent and long-acting IP (prostacyclin) receptor agonists and has shown potential to improve mechanisms relevant to selected CVDs.
The goal for both programs is to move to clinical Phase I after a 24-month preclinical evaluation period that began in the second quarter of 2021.
Strong IP portfolio and financial position
In 2021, Cereno also took important steps to expand its patent portfolio to optimize the commercial position of each program. This is particularly true for CS1, which has been granted patent protection in most major global markets, including the US, Japan, Canada, Australia, Russia and Europe. In September, the CS585 program received a first patent covering the strategic US market.
Regarding the company's financial situation, Cereno's TO1 series warrants were subscribed to 96,9 percent, which signals a high level of trust and commitment from shareholders. In October, Cereno thus received SEK 95,3 million before issue costs, which ensures the planned development of the company's clinical as well as preclinical programs.
Comments from the CEO
As we turn the page to 2022, Cereno is well positioned to continue its ambition to develop innovative treatments for CVD patients. In addition to a robust drug development pipeline, the company has been able to attract key competencies and build a solid organization in scientific research, intellectual property, drug development and commercialization.
A dedicated board and a SAB consisting of high-profile and internationally recognized CVD experts (read more here) constitutes a good foundation for continued development. Cereno also has a very experienced group management team, led by CEO Sten R. Sörensen, which below tells you about the company's most important milestones in 2021 and what you can look forward to in 2022.
»Looking ahead a year, I hope that we have been able to communicate positive results from our Phase II study with CS1 in PAH, for which we expect to have topline data by the end of 2022, and that preparations for the next study in this program are well underway.« — Sten R. Sörensen, CEO Cereno Scientific
Sten, how would you like to summarize Cereno's progress in 2021?
– We have achieved many important key milestones in both our clinical and preclinical programs and have taken important steps towards delivering in line with our strategy, creating value for both CVD patients and our shareholders. I am very proud of the commitment and rewarding results that the entire team has delivered during the year, in collaboration with our strong network of partners.
How far do you estimate that the proceeds from the TO1 warrant will last?
– The SEK 95 million raised through the exercised TO1 warrants allows us to continue at full speed with our three development programs. With the activities currently planned for these programs, we should be fully funded until the TO2 warrants are due for redemption in September 2022. If fully exercised, TO2 will generate up to SEK 115 million before expenses at the maximum subscription price.
Do you expect the pandemic to affect the progress of the Phase II study?
– Since the beginning of the pandemic, we have seen its impact on many other clinical programs, mainly in terms of projected timelines. There is a risk of a negative impact on our Phase II study as well. However, as this is a limited study, involving only 30 patients and relatively few clinical centers in the US, I am hopeful that we will be able to effectively address all pandemic-related challenges.
– As a preventive risk-mitigation measure, we have increased the number of trial centers from six, up to a maximum of nine. This way, we will be able to better respond to potential challenges related to the pandemic.
Finally, what do you imagine will be the most talked about thing about Cereno in a year?
– Looking ahead a year, I hope that we have been able to communicate positive results from our Phase II study with CS1 in PAH, for which we expect to have topline data by the end of 2022, and that preparations for the next study in this program are well underway.
– I also expect that our two preclinical programs have made significant progress and are approaching IND submission and initiation of Phase I studies. Our plan is to share more information about these two promising programs in 2022.
– In conclusion, I am very excited about what 2022 has in store for our journey, the ultimate goal of which is to offer better treatments to patients with both common and rare cardiovascular diseases.