Chordate presents conclusions from the second data monitoring of the ongoing open-label long-term study on chronic migraine: PM010


27 juni, 08:30

Since this Post Market Surveillance study is open (uncontrolled), it is possible – as well as the sponsor's responsibility – to actively monitor study data during the ongoing study. It is regulatory and scientifically permissible to summarize both efficacy and safety data.

As approximately fifty percent of the maximum patient population was recruited to the study, it was decided to carry out a follow-up of the data collected so far.

The purpose of the monitoring was a partial summary of the data – with a focus on some of the efficacy data – that were registered in the study from the start of inclusion until 26 May 2025. The study is still ongoing for the patients who are in the study, the recruitment of new patients has been discontinued because data compilation shows such satisfactory results that additional data cannot significantly improve the outcome.

The conclusion reported by the study's statisticians from the monitoring was as follows:

  • Results for the primary endpoint/endpoint: "the reduction in moderate or severe headache days during the last four weeks of the six-week initial treatment period" statistically demonstrate a clinically relevant reduction in the number of headache days compared to baseline (four-week baseline measurement period). This confirms the overall results published for the PM007 study: https://www.neurology.org/doi/10.1212/WNL.0000000000210220.
  • Regarding the main secondary endpoint: "Change from baseline in proportion of migraine days over 12 months from first treatment" also shows with statistical certainty a clinically relevant reduction in the number of days with migraine compared to baseline, over a reassuring period – where the study has so far collected a sufficient amount of data. The same applies to the reduction of headache days, but where the period of significant reduction is even longer.

“It is very gratifying that PM010 now with statistical significance further confirms the results from the PM007 study. This is of great importance in the work with the exit process," says Anders Weilandt, CEO of Chordate, and continues:

“This is a long study with twelve months of follow-up, and data is still being collected. An in-depth analysis is now underway to determine whether it is likely that such good results can be improved from a statistical perspective, or whether the data we have is sufficient to present a final picture of results.”

For more information, please contact:
Anders Weilandt, CEO
anders.weilandt@chordate.com
Cell: +46 733-874277

About Chordate
Chordate Medical Holding AB (publ) is a medical technology company that has developed, patented and CE-marked Ozilia® Migraine, a neuromodulation and drug-free treatment technology for chronic migraine and chronic rhinitis. The treatment has clinically proven efficacy according to a recent study, and is marketed in selected markets in the EU and the Middle East. Chordate Medical is listed on Nasdaq First North Growth Market Stockholm (ticker: CMH). Read more at www.chordate.com

The company's Certified Adviser on Nasdaq First North Growth Market Stockholm is Bergs Securities AB.

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.

Attachments
Chordate presents conclusions from the second data monitoring of the ongoing open-label long-term study on chronic migraine: PM010

Läs mer på MFN



Marknadsöversikt

1 DAG %

Senast

1 mån
Senaste aktieanalyserna på Placera
Kollage Analys Ny
Privatekonomi med Placeras expert
Karolina Placera

Karolina Palutko Macéus skriver om allt som har med privatekonomi att göra och hur du kan få mer pengar i plånboken.

Affärsvärlden
AFV

Är du kund hos Avanza? Just nu kan du få en unik rabatt på Affärsvärlden. Afv har 28 år i rad utsetts till Sveriges bästa affärsmagasin i en undersökning med börs-VD:ar, finanschefer, IR-chefer och aktieproffs.

Annons
Introduce

för börsens små- och medelstora företag.

Annons
Investtech

Här hittar du våra artiklar om teknisk analys i samarbete med Investtech.