Chordate Medical has developed Kinetic Oscillation Stimulation (KOS), a neuromodulatory and drug-free treatment technology for chronic migraine and chronic nasal congestion (rhinitis). KOS is a medical device that is placed in the patient's nasal cavity, where it induces an autonomic response through vibrations.
Last year, Chordate Medical completed a study (PM007) in migraine patients that showed that KOS significantly reduces the number of monthly headache days (MHD) of moderate to severe intensity. In June, the results were presented at two congresses – American Headache Society Scientific Meeting and The German Migraine and Headache Society's congress.
Presentation at the American Headache Society Scientific Meeting
On June 17, Dr. presented Jan Hoffmann from King's College London at the annual scientific meeting of American Headache Society. This is the largest scientific conference in the United States for healthcare professionals and researchers specializing in headache disorders. This year's edition of the meeting was organized in Austin, Texas, and was attended primarily by specialists from the United States, but also international experts.
Dr. Hoffmann's lecture was attended by approximately 300 migraine specialists. CEO Anders Weilandt also attended the congress to meet with industry specialists and researchers. According to him, Dr. Hoffmann's presentation was received with great interest, judging by the subsequent questions from the audience.
Case report presented in Berlin
In addition, the study's co-authors Dr. Charly Gaul presented the study results at The German Migraine and Headache Society Congress in Berlin on June 30. Dr. Tim P. Jürgens also participated to present a case report written by Dr. Florian RimmeleThe case report describes one of the patients in the study, a 45-year-old woman who has suffered from chronic migraine with visual aura for a long time.
In her case, the most common preventive medication could not be used due to systemic mastocytosis and other medical conditions. KOS was found to be well tolerated and long-term prophylactic for the patient. Her number of days per month with migraines decreased significantly, from 18 to 8 days per month. The positive effect of KOS treatment lasted for four months without further treatment sessions. Read the case report here.
Study results in detail
The clinical study PM007 was conducted to evaluate the efficacy of intranasal KOS treatment for the preventive treatment of chronic migraine. 132 patients with chronic migraine received either intranasal KOS stimulation (85 Hz, 80 mbar) or sham stimulation (no vibration) once a week for 10 minutes per nostril for 6 weeks.
Patients receiving active KOS treatment experienced an average reduction of 3,5 migraine days/month. The number of headache days decreased by approximately the same number of days during the observation period, indicating a sustained treatment effect during the 4-week follow-up period. The active treatment group had significantly better results compared to the sham group in terms of both migraine and headache days. The study also showed that the treatment was well tolerated with no serious side effects, indicating a favorable side effect profile.
Interview with Dr. Hoffmann
BioStock contacted Dr. Hoffmann to learn more about the results from the PM007 study.
First of all, why do we need alternatives and complements to today's treatments for chronic migraine?
- Despite having a range of effective treatment options for chronic migraine there is still a significant unmet need for patients with migraine.
– The main reasons for this unmet need are the facts that all currently available preventives are only effective in a certain percentage of migraine patients, they frequently cause significant side effects that can have an important additional impact on the quality of life, and the problem that some of these medications are contraindicated in the presence of some of the most common comorbidities such as for example depression. In particular because of the potential side effects and negative past experience with systemic preventive treatments, patients with migraine are frequently interested in non-pharmacological treatment alternatives.
»Despite having a range of effective treatment options for chronic migraine there is still a significant unmet need for patients with migraine. […] Patients with migraine are frequently interested in non-pharmacological treatment alternatives.«
What were the most interesting findings in the PM007 clinical trial with KOS according to you?
– Aside from the clinical efficacy, in my opinion the two most interesting findings are the sustained treatment effect throughout the follow-up period and the favorable side effect profile.
Could you explain how KOS affects the autonomic nervous system and reduces the number of headache days?
- We do not yet understand in detail the exact mechanisms underlying the treatment effect of KOS in chronic migraine. However, as kinetic oscillation of the nasal cavity elicits trigeminal cranial autonomic symptoms such as lacrimation (tear-flow), given the preclinical and clinical evidence that modulation of the parasympathetic outflow which mediates these symptoms can be favorable in the context of migraine, and the anatomical proximity to the relevant structures such as the sphenopalatine ganglion, it seems likely that KOS may act by influencing the parasympathetic outflow thereby modulating the so-called trigemino-autonomic reflex which in turn could lead to the observed reduction in headache frequency.
What were the overall reactions and thoughts on KOS at the congress?
- In general, the audience was very interested in the findings which were reflected in the questions and discussions that followed the presentation. For the attendees, the findings were of great interest as KOS is based on an entirely new and non-pharmacological treatment concept. In addition, in contrast to some of the other available neuromodulation techniques, the efficacy of KOS was demonstrated by a sham-controlled trial and not just by an open-label study. In this context, considering the non-pharmacological nature of the treatment and the unmet need from a patients' perspective, KOS clearly raised a significant interest among attending clinicians.
»For the attendees, the findings were of great interest as KOS is based on an entirely new and non-pharmacological treatment concept. In addition, in contrast to some of the other available neuromodulation techniques, the efficacy of KOS was demonstrated by a sham-controlled trial and not just by an open-label study.«
In addition, a recently presented case study demonstrates the potential of KOS in patients who, for various reasons, cannot medicate with drugs typically prescribed for chronic migraines. Why is KOS a valuable treatment for this kind of patient?
– Because of its non-pharmacological mechanism and the resulting favorable side effect profile, KOS provides an alternative for patients for whom other treatments were ineffective or not tolerated as well as for patients who prefer a non-pharmacological treatment approach. The reported patient reflects this situation and highlights the importance of both the current unmet need and the positive impact KOS can have on a patient's quality of life.