Chordate Medical has two active studies, and another two that are in the planning stage. The purpose of the company's clinical development program is to support the ongoing market introduction of the K.O.S technology for chronic migraine in the EU and lay the foundation for regulatory market access in other markets such as the USA.
"Our clinical development strategy is aimed to conduct studies of specific nature and shorter duration ourselves, and to encourage and facilitate other independent external investigator-initiated studies once such opportunities arise", says Anders Weilandt, CEO Chordate.
The randomized controlled patient study PM007, that is being carried out at 9 clinics in Germany and Finland, will see the last subject leaving the study at the end of July 2022. A manuscript for a scientific article will be submitted for publication at the end of October 2022, at the earliest. This study will have recruited approximately 132 subjects with chronic migraine and the primary endpoint is the reduction of headache days.
The study on chronic rhinitis, PR008, will complete the clean data file June 2022, whereafter analysis and publication work will follow.
The planned study PM009 is an open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation (K.O.S) in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway. The study's aim is to include 25-30 subjects to investigate the reduction of headache days using the K.O.S technology. Blood samples will be evaluated for relevant biomarkers. The study is conducted at King's College in London with three to four referring clinics assisting with the recruitment of suitable subjects for the study. The objective with this investigation is to detect a potential positive effect. Any level of positive result will likely mean a great opportunity for our company as this challenged patient group has very few options left.
PM010 is another planned study, which is an open post-marketing clinical follow-up investigation to follow long-term performance and safety of intranasal kinetic oscillation in subjects with chronic migraine during regular clinical treatment. The study will recruit 200 subjects and will be conducted at approximately 15 clinics in three to four European countries, the follow-up is 12 months. Data from this open study will be reported in intervals and used to fine-tune recommendations for the clinical regime.
For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Cell: +46 733-874277
The following documents can be retrieved from beQuoted
Chordate-Medical-pipeline.png
Chordate-Medical-updates-on-ongoing-and-planned-clinical-stu.pdf
About Chordate
Chordate Medical Holding AB (publ) is a medical technology company that for over ten years has developed, patented and CE-marked a new neuromodulation treatment technology for chronic nasal congestion (rhinitis) and chronic migraine. The company offers its product via distributors to clinics and hospitals in selected European markets, Israel, and Saudi Arabia. Chordate Medicals share is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com
Chordate's Certified Adviser on Nasdaq First North Growth Market Stockholm is Västra Hamnen Corporate Finance AB, +46 40 200 250, ca@vhcorp.se.
N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail.
