Regulatory approval and up-listing for Cyxone
Activity is high in Cyxone. The biotechnology company recently received approval to start a phase II study in Poland with Rabeximod in patients suffering from moderate Covid-19. They have also announced the intention to apply for listing of their share on Nasdaq Stockholm’s main list. BioStock reached out to CEO Tara Heitner, who shares her thoughts on the timing of the up-listing and how Rabeximod can open up for the treatment of respiratory diseases, beyond Covid-19, caused by viral infections.
Cyxone arguably reached one of its most important milestones of the year last week with the approval from the Regulatory Authority and the Ethics Committee of Poland to launch the planned phase II study with Rabeximod in patients suffering from moderate Covid-19.
The goal is to prevent moderate symptoms from progressing to severe
The main cause of more serious complications of Covid-19, caused by the coronavirus SARS-CoV-2, is an overreaction by the immune system which causes a hyperinflammatory condition called a cytokine storm, which in turn could lead to a severely impaired lung function similar to ARDS (Acute Respiratory Disease Syndrome). Therefore, being able to prevent the moderate symptoms from progressing to this potentially fatal condition, became one of Cyxone’s focus areas earlier this year.
In mid-September, the company announced that it intended to initiate a clinical phase II study with the treatment of the drug candidate Rabeximod in Covid-19 patients. The goal is to reduce the risk of the serious respiratory problems caused by virus-related overactivity of the immune system.
Interim data are expected during Q3 2021
Sites for the clinical trial in Poland have been contracted, while an application has been submitted to the regulatory authority in Slovakia and applications are being prepared in additional countries. Simultaneously preparations are currently underway to recruit 300 patients for the study with moderate Covid-19 who are in need of oxygen therapy but not respiratory therapy.
Cyxone expects preliminary results from the fully funded clinical study during the third quarter of 2021.
The CEO comments
BioStock reached out to Cyxone’s CEO Tara Heitner to find out more about the study, the possibilities of expanding the company’s pipeline towards additional respiratory diseases, and the plans for a list change.
Tara Heitner, what is your view on the chances of success in the phase II study, based on what is known about Rabeximod’s mechanism of action?
– Based on what we know about Rabeximod’s mode of action there is a very strong chance that our drug candidate will protect moderately affected patients from progressing to a severe or acute disease. In some patients the infiltrating macrophage in the lung can become hyperactivated leading to a cytokine storm which if untreated can cause events that lead to death. The in vitro, in vivo and human data we have so far generated support that Rabeximod will be able to suppress the cytokine storm. We also have evidence that Rabeximod does distribute to the lung so all this together is what supports a role for Rabexmod in saving the lives of Covid-19 infected patients.
You have plans to enter into a partnership with a global pharmaceutical company in the area of respiratory diseases caused by viral infections. Can you tell us more about these plans?
– We have reached out to potential partners to discuss their interest in collaborating on future development and commercialization of Rabeximod in Covid-19 and other respiratory viral infections. It is still early days, but of course there is indeed a lot of interest from the market. This is an area with huge long term market potential.
What is the medical need to counteract the development from a moderate to a serious illness in patients developing Covid-19?
– Hospitalized Covid-19 patients are putting a large burden on our health care systems causing a domino effect on other patients due to lack of resources and hospital beds. It is imperative to shorten or avoid hospital stays and this is where Rabeximod could be of very high value. Once patients are on a respirator it may already be too late for intervention with Rabeximod and other drugs.
– I quote the recent article entitled “Therapy for Early COVID-19 A Critical Need” by Peter S Kim MD- “Given the duration and severity of the COVID-19 pandemic, investments into targeted de novo drug design approaches for early treatment are also warranted.” “While the current pipeline of treatments provides hope that effective, early–COVID-19 therapeutic may soon be available, much work remains to be done. Continued research is needed to refine current treatment candidates and develop new drugs that can be dosed without requiring intravenous infusions or other complex maneuvers.”
– This very timely article which came out one month ago in Journal of the American Medical Association thus underscores the need for vaccines, anti-virals and anti-inflammatory agents such as Rabeximod in the arsenal of drugs against Covid-19 if we are to be successful in fighting this pandemic and pandemics yet to come.
There are currently a couple of vaccines that most likely will be on the market within short. Why is it still relevant to conduct this Phase 2 study in Covid-19 patients?
– This is actually a question that we get asked a lot. It is important to understand that Rabeximod is being developed as a treatment not just for Covid-19 but for almost any viral induced airway infection which could progress to overreaction of the immune system and a cytokine storm. Thousands die every year from influenza and pneumonia for example. If efficacy is shown, Rabeximod would be relevant for SARS, Covid-19, the flu and potential future pandemics caused by other viruses.
– The fast development of Covid-19 vaccines has been remarkable, and I am very impressed with what our industry has been able to accomplish in such a short time due to cooperating and collaboration. However, a vaccine is not the endpoint. Vaccinations needs to cover about 70% of the population to elicit a protective effect. This will require robust manufacturing and distribution plans, culturally sensitive communication strategies, a population that will take the vaccine and funding to execute. In some areas, the infection rate may already be too high for the vaccine to make a difference. Treatments will always be needed even when vaccines are available as we don’t yet know how a patient’s age will affect response to treatment, how long the protection will last for, and if the virus will mutate.
– Furthermore, both vaccines and therapies are needed to end the pandemic. Peter S Kim also writes ”Outpatient treatments for COVID-19, coupled with an effective vaccine, would have significant implications for the ability to end this pandemic.” And “Preventing hospitalizations and the chronic sequelae of COVID-19 will not only save lives, but also will help restore medical systems and other institutions that are overburdened by the effects of the pandemic. Effective, early treatments will also mitigate gaps left by previous and current prevention strategies and curtail forward transmission”.
Finally, you plan to apply for a list change to Nasdaq Stockholm’s main list at the beginning of 2022. What is the main purpose and why in 2022?
– Cyxone is growing and we would like to increase our profile both on the national and international level. A listing on Nasdaq Stockholm Main Market would provide a quality mark on the company and would improve our opportunities in building an even wider and stronger shareholder base.
– As for the timing, we are building a company with a strong development project portfolio and organisation to match. The listing process including the fulfilment of the listing criteria will take both time and effort. We have decided that the spring 2022 timing is optimal for Cyxone to be able to both properly fulfil the listing requirements and realize the full potential of the company at the same time.
Watch Tara Heitner’s presentation at BioStock Life Science Summit 2020 below.
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.