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Promising results in Chordate’s follow-up study

Chordate

Promising results in Chordate’s follow-up study

6 September, 2024

Chordate Medical has conducted an initial data analysis in the long-term study PM010 with its migraine treatment Ozilia. According to the company, the results are promising, both in terms of the primary and secondary endpoints. The company’s CEO, Anders Weilandt, shares more about the results in an interview with BioStock.

Chordate Medical’s product Ozilia is a medical device treatment method for chronic migraine that has been CE marked since 2021. The drug-free treatment has a preventive effect and is currently marketed in selected markets within the EU and the Middle East.

Post Market Surveillance study PM010

In the fall of 2023, Chordate Medical initiated a long-term follow-up study, PM010, to monitor the long-term performance and safety of Ozilia in patients with chronic migraine. The study is a so-called Post-Market Surveillance study, which is part of the regulatory requirement for CE marking. Additionally, the study will assist doctors in fine-tuning the treatment recommendations for Ozilia.

The PM010 study is being conducted at clinics in four European countries and aims to recruit a total of approximately 200 patients. The study is open, meaning it is possible to monitor and report data continuously.

An initial data reading

When about 25 percent of the patient population was recruited, it was decided to perform a monitoring of the data collected so far. The data monitoring focuses on efficacy data collected in the study from the start until August 23. The conclusions from the statistical data analysis suggest promising results regarding the primary endpoint – the reduction of days with moderate or severe headaches. The main secondary endpoint, change from baseline in proportion of migraine days, also shows promising results.

– I am very satisfied that PM010 thus far confirms the results from the pivotal randomized controlled trial PM007. The results are surprisingly clear, already at this early stage, says CEO Anders Weilandt in a press release.

Anders Weilandt
Anders Weilandt, CEO of Chordate Medical

CEO comments

The study is still ongoing with a total follow-up period of 12 months, meaning more data will be collected. In addition, the company has another ongoing study, PM009, which evaluates the effect of Ozilia as a preventive treatment for patients with chronic migraine who do not respond to CGRP inhibitors and other migraine medications.

BioStock reached out to CEO Anders Weilandt to learn more about the initial data reading and how it confirms that the study is progressing in the right direction.

First and foremost, how important are the initial results from the study for your ongoing market activities?

– It is absolutely crucial to get a checkpoint that shows the study is on the right track, so we do not allocate resources to the wrong things. In an open study, you can do this at appropriate times, compared to a normal clinical study where interim analyses only can be done if specified in the study design. The indication we have now received is obviously an advantage in our marketing – even though we are not sharing many specific details.

In a press release, you mention that the sensitivity analysis supports both the primary and secondary efficacy measures. What does this mean, and how does it affect your interpretation of the results?

– All patients in the study keep an electronic diary throughout the entire study. Naturally, some days are missed. The study protocol anticipates this, which is why in the analysis, mathematical methods are used to fill in the gaps. There is already a large amount of data points in the material. Sensitivity analysis is done by comparing statistical results from the dataset with filled gaps to those without them. In this case, the outcomes were very similar, which suggests the analysis model is stable.

Can you tell us more about the efficacy objectives used in the study and why these were chosen?

– They are mainly the same efficacy measures and assessment criteria used in PM007 to allow for comparisons between the studies.

Have you seen any differences in the results compared to your previous study, PM007?

– At this stage, I can only say that the data monitoring of PM010 confirms the results from PM007.

You have previously mentioned that the study is being conducted at specialist clinics with a high patient flow and a focus on regular clinical practice. Can you tell us more about the clinics?

– The clinics participating in PM010 primarily focus on treating patients rather than academic research. However, there are some exceptions where both aspects are equally emphasized. What matters most is that these clinics handle a high volume of patients.

Finally, when do you expect to have a complete follow-up of all data from the study?

– There is not enough data yet to make any predictions. Some clinics started late, and some are only beginning now. We will revisit this once the study is progressing at a more regular level. Recruiting, and especially recruiting the right participants in clinical studies, is always a challenge.

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.

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