The first patient has now been enrolled in Chordate Medical’s open pilot study PM009, which aims to evaluate the effect of the company’s migraine treatment Ozilia on patients who do not respond to treatment with CGRP inhibitors and other treatment options. BioStock reached out to the company’s Clinical Research & Medical Director, Jan Hermansson, to find out more about the study.
Chordate Medical is a medtech company that has developed Ozilia Migraine (formerly K.O.S), a neuromodulation and drug-free treatment technology for chronic migraine and chronic rhinitis. The treatment is marketed in Finland, Germany, the UK, Italy, Israel and the Gulf region.
Ozilia has been proven efficacious in a previous patient study (PM007), but the company continues to initiate studies to build on the clinical evidence around the treatment. The purpose of the company’s clinical development program is twofold: to support the ongoing market introduction of Ozilia for chronic migraine in the EU and at the same time lay the foundation for regulatory market approval in the US and other markets.
Initiates open pilot study
The company is now announcing that the first patient has been enrolled in PM009, an open pilot study aimed at patients whose migraines do not respond to treatment with CGRP inhibitors and other traditional drugs.
CGRP inhibitors are a relatively new group of drugs for the treatment of migraine. The treatments work by inhibiting CGRP (calcitonin gene-related peptide), which is a neurotransmitter that plays a central role in migraines.
Patient group in great need of treatment options
The study is being conducted at King’s College London with 3 – 4 referring clinics and the goal is to include 25 – 30 patients. The study is led by Dr. Jan Hoffmann, who was also responsible for the company’s previous study PM007.
The company’s hope is that the PM009 study will show that Ozilia provides a preventive effect on patients who do not have many more treatment options left to try. The patients participating in the study have already tried at least three preventive drugs before being treated with CGRP inhibitors. When that also fails, there are not many other options available.
Comments from Clinical Research & Medical Director
BioStock reached out to Dr Jan Hermansson, Clinical Research & Medical Director, to find out more about the PM009 patient group and the design of the study.
Could you first tell us about the patient group in the PM009 study and their need for new treatment options?
– These patients have already tried several different drugs including CGRP inhibitors without sufficient effect, i.e. they are severely disabled by their migraines, that they have at least 8 days per month. Ozilia can then be an alternative to medication, or be taken as a supplement to reduce the number of migraine days.
As the person responsible for the study at Chordate, you are very involved in the study. How would you describe the collaboration with King’s College?
– King’s is a leading clinic where one of the world’s most renowned migraine researchers, Prof Peter Goadsby, is the clinical director, and Dr. Jan Hoffmann works closely with him. The clinic is located in Denmark Hill in London and has a high patient throughput. Dr. Hoffmann has several PhD students assisting him in the study, which hopefully will facilitate the inclusion of new patients in the study. The clinic has a lot of experience in clinical studies, so I have high hopes with regards to quality and results.
What are the endpoints of the study?
– The number of migraine and headache days is measured daily via an electronic diary. Even a reduction of 2 – 3 migraine days per month is considered a significant improvement for the patient. Since the study is open, we can continuously follow the patients and see the trends.
What is required for the study to be considered successful?
– Of course, we hope that many patients will have a significant reduction in their migraine and days with headache. Every patient who reports improvement will be considered a success, especially since other alternatives have not had the desired effect.
Finally, what would it mean for patients if the study shows that Ozilia has a positive effect?
– That they can have more days per month with significantly improved quality of life, to be able to work and spend time with their family. The fact that our treatment is completely free of drugs is appreciated by many patients, and there is an interest already now among patients with chronic migraine!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.