Chordate Medical is a medical technology company that has developed Ozilia Migraine (formerly KOS), a neuromodulatory and drug-free treatment technique for chronic migraine and chronic rhinitis. The treatment is marketed in Finland, Germany, the UK, Italy, Israel and the Gulf region.
Ozilia has proven efficacy from a previous patient study (PM007), but the company continues to initiate studies to build on the clinical evidence for the treatment. The purpose of the company's clinical development program is twofold: to support the ongoing market introduction of Ozilia Migraine for chronic migraine in the EU while simultaneously laying the foundation for regulatory market approval in the US and other markets.
Initiates open pilot study
Now the company announces that the first patient has been included in PM009, an open-label pilot study targeting patients whose migraines do not respond to treatment with CGRP inhibitors and other traditional medications.
CGRP inhibitors are a relatively new class of drugs for the treatment of migraine. The treatments work by inhibiting CGRP (calcitonin gene-related peptide), a neurotransmitter that plays a central role in migraine.
Patient group in great need of treatment alternatives
The study is being conducted at King’s College in 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 hopes that the PM009 study will show that Ozilia has a preventive effect in patients who do not have many other 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 does not work either, there are not many other options available.
Clinical Research & Medical Director comments
BioStock contacted Dr. Jan Hermansson, Clinical Research & Medical Director, to learn more about the patient group in PM009 and the study design.
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 medications including CGRP inhibitors without sufficient effect, so they are severely disabled by their migraines, which they have at least 8 days per month. Ozilia can then be an alternative to medication, or taken as a complement 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 director, and Dr Jan Hoffmann works closely with him. The clinic is located in Denmark Hill in London and has a high patient flow. Dr Hoffmann has several PhD students assisting him in the study, which hopefully makes the inclusion of new patients in the study easier. The clinic has a lot of experience in clinical studies, so I have high hopes for quality and results.
What efficacy measures does the study have?
– The number of migraine and headache days is what is measured daily via 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 trends.
What is required for the study to be considered successful?
– Of course, we hope that many patients will experience a significant reduction in their migraine and headache days. Every patient who reports improvement will be considered a success because they have already shown that other options 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, being able to work and spend time with their family. The fact that our treatment is completely drug-free is appreciated by many patients, and there is already interest among patients with chronic migraine!