Just two weeks ago, announced Cereno Scientific to FDA approved the company's so-called Investigational New Drug (IND) application to initiate a phase II study in pulmonary arterial hypertension (PAH).
This was an important milestone for the company as it meant that it could begin the final preparations for initiating patient recruitment.
BioStock has previously published a panel discussion with the company's CEO Stone R Sorensen, CMO Dr. Bjorn Dahlof, and the principal investigator for the study, Dr. Raymond Benza, regarding the IND approval. Read more detailed information about the upcoming Phase II study and its significance here.
The search for better treatments for cardiovascular diseases
The IND news is of great importance to the company in its efforts to develop better treatments for a broad spectrum of cardiovascular diseases. The disease group includes the rare cardiovascular disease PAH where Cereno is developing its lead candidate CS1Here Cereno can benefit from the Orphan Drug Designation (ODD) that the FDA granted in March 2020.
While CS1 has the potential to be clinically validated in PAH, Cereno Scientific has also laid the foundation to expand the pipeline by diversifying its candidate portfolio. In collaboration with University of Michigan in Ann Arbor, USA, the company is evaluating the potential of two new preclinical programs: CS585 and CS014.
CS585 is a stable, selective and potent IP (prostacyclin) receptor agonist that has shown potential to significantly improve mechanisms relevant to selected cardiovascular diseases through initial animal models in vivo. Meanwhile, the preclinical program for CS014, like CS1, is based on HDAC-inhibitory epigenetic mechanisms and is also being evaluated for the treatment of cardiovascular diseases. The goal of both preclinical programs is to reach clinical phase I in 2023.
Read more about CS585 here and about CS104 here.
High utilization rate of warrants
Cereno now has – thanks to the company's TO1 series warrant being exercised at 96,9 percent – financial resources to continue to drive not only the Phase II study with CS1, but also the two preclinical programs, and thus reach upcoming milestones within each program.
Through the exercise of the warrants, Cereno will receive approximately SEK 95,3 million before issue costs.
Cereno Scientific CEO Sten R Sörensen expressed his joy in a press release:
»It is very pleasing to see the high utilization rate achieved. The successful issue demonstrates the confidence in Cereno from shareholders, which is probably due to a combination of our success in achieving several important milestones over the past twelve months and the great potential that can be realized in the company's continued development as we move our promising programs forward. We are currently working hard to implement our Phase II clinical study with CS1 in pulmonary arterial hypertension and there is also high activity in the two preclinical programs being conducted in collaboration with the University of Michigan. The capital that we are now providing allows us to drive these development programs forward with full force and to continue to develop Cereno's technology platform, which has the potential to offer better and safer treatments for common and rare cardiovascular diseases where there is a high medical need.«
On solid ground for the future
The outcome of the warrant program is a clear sign that shareholders strongly believe in the company and its vision. Cereno can now proceed with its Phase II clinical study with CS1 and its preclinical programs with confidence.
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