Patient enrollment of Phase III of clinical trials for Ascelia’s drug candidate Orviglance has been completed. At the time of writing, the efficacy and safety results are all that remain for Orviglance before a submission can be sent to the US Food and Drug Administration (FDA) for approval and subsequently launched, the greatest milestone for the entire project is within reach.
“We are of course very excited to bring our novel first-in-class drug to the patients in need. With Orviglance we have the potential to change the lives of people who have medical needs not addressed today, and based on the results of our eight previous studies, we are optimistic. Our next step will then be to build a focused team in the US, where we have identified a very attractive commercial opportunity”, says Magnus Corfitzen, CEO of Ascelia Pharma.
Ascelia already has a legal entity in place in the US. The global team with development, regulatory, commercial strategy and operations is located in Malmö, where the possibility of attracting the best talents from both sides of the Oresund strait is great. Magnus Corfitzen has commuted from Copenhagen to Malmö over the past nine years and describes the journey as easy to make thanks to the excellent infrastructure in the region.
Orviglance to be the standard of care
Orviglance has been developed to help patients who are not recommended to have the MRI contrast agents that are available today. These agents contain gadolinium, which could cause the serious and potentially fatal condition Nephrogenic Systemic Fibrosis, NSF, in patients with severely impaired kidney function.
Today, the standard management of patients with severely impaired kidney function is liver MRI without a contrast agent; also called an unenhanced MRI. However, this reduces the ability to detect and visualize cancer in the liver, and therefore to treat optimally. An unenhanced MRI consequently risks reducing a patient’s chances of survival.
There is, therefore, a need for a safer liver contrast agent for patients with severely impaired kidney function. Orviglance aims to fill this role and be the standard of care for these patients and has been granted Orphan Drug Designation by the FDA.
No other developer in the world has come as far as Ascelia when it comes to addressing this unmet need. With Orviglance, Ascelia sets a high standard with a first-in-class product targeting an addressable market opportunity of $800 million.
First in class once again
“We are unique in the sense that we focus entirely on unmet medical needs with both of our drug candidates”, says Magnus Corfitzen.
With the second drug candidate, Oncoral, Ascelia is focusing on patients with gastric cancer, the third most frequent cause of cancer mortality.
There are several chemotherapeutic drugs on the market, and one well-established and effective molecule is irinotecan. It has a proven anti-tumor effect and is approved for combination use in several solid cancer indications. The biggest challenge is that irinotecan is only available as a high-dose intravenous infusion, causing harsh side effects as a result.
Ascelia’s suggested solution is Oncoral, a daily irinotecan tablet with the potential to offer better patient outcomes with improved efficacy and safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital every three weeks. Following successful Phase I results, Oncoral is now ready for Phase II clinical development. Just like Orviglance, Oncoral will be a first-in-class product, if all goes according to plan with the upcoming trials.