“It is highly gratifying that all key efficacy endpoints defined in the study design have been met with statistical significance, and that the long-term follow-up confirms the preventive effect of the Ozilia treatment. This means we will close the study in August,” says Anders Weilandt, CEO of Chordate.

“Although additional data and further analyses will be performed ahead of a forthcoming full publication, this selection of results provides a clear indication of reduced medication intake and annual need for Ozilia treatment as long-term effects. The overall outcome strongly reinforces our ongoing efforts to sell the company.”

As approximately half of the study population had been recruited, a statistical monitoring analysis was conducted on the data collected. The purpose of this monitoring was to assess whether the data – focusing on a selection of efficacy outcomes recorded from the start of patient inclusion until May 26, 2025 – would be sufficient to meet the study objectives.
Parts of the preliminary analysis, as reported by the study statistician and pending full analysis and publication of all data, are summarized below:

• Primary endpoint results for all participants:
  “Change from baseline (i.e. 4-week screening period) in the proportion of days with moderate-to-severe headache compared with the 4-week period starting the day after the third treatment” showed an average reduction of more than 4 headache days, with high statistical significance.

• Secondary endpoint results (selected) for all participants:
  a) “Change from baseline in the proportion of migraine days (regardless of intensity)” showed an average reduction of more than 4 migraine days, with statistical significance.
  b) “Proportion of participants with a ≥30% and ≥50% reduction in moderate-to-severe headache days” showed 29% achieving ≥30% reduction and 14% achieving ≥50% reduction.

• Secondary endpoint results (selected) from long-term follow-up (estimated over 365 days) for all participants:
  c) “Change (from baseline to 28-day periods after Visit 3) in the proportion and number of days with moderate-to-severe headache and/or migraine” showed a statistically significant reduction in the proportion of headache days compared with baseline, calculated across the entire one-year period as well as in each half-year period.
  d) “Change from baseline in the proportion of migraine days compared with periods after Visit 3” showed a statistically significant reduction up to approximately 200 days, after which the number of reporting participants became too small for analysis.
  e) Subgroup analysis of participants reporting >2 days’ reduction in headache days chosed to receive approximately 5.6 treatments per year.
  f) “Change from baseline in the proportion of days with medication use compared with periods after Visit 3” showed a reduction in the number of days with medication over the one-year period, with a statistically significant reduction between approximately Day 60 and Day 200, after which the number of reporting participants became too small for analysis.

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.”

“We already have a distributor in Saudi Arabia, but we see a need to increase focus and expertise in the neurology field. Narro Medical fits well into that strategy and is currently in the final stages of the qualification process. This includes demonstrating effective sales activities in the field, taking over the work with prospective customers we have previously engaged, and placing qualifying orders for demo equipment and stock – something they have successfully accomplished so far,” says Anders Weilandt, CEO of Chordate Medical.

Ozilia is currently offered as a rhinitis treatment at nine clinics in Jeddah and Riyadh. In September 2024, Chordate received its first order for Ozilia migraine treatment in Saudi Arabia, and shortly thereafter, the Saudi Food and Drug Authority (SFDA) approved the company’s application for market authorization for the migraine indication.