AcuCort’s Phase IV study ZEQ001 for Zeqmelit® is progressing as expected. The tenth patient has been allocated the oral film for use when needed for the treatment of acute allergic reactions.
As previously communicated, the Phase IV study ZEQ001 regarding the oral film Zeqmelit® commenced at the end of January. The purpose of the study is to collect scientific data related to the launch in the Nordic region from practical experience of patients. The recruitment of patients for the study meets AcuCort's high expectations. Already after one week, ten allergy patients are included in the study, which is planned to encompass a total of 50 patients.
"It can be challenging to recruit patients for studies in pharmaceutical development. It is gratifying that our study has already recruited ten patients. It is positive that there is such great interest in our medicinal product among physicians and patients, indicating a significant need for a simple and effective treatment," says Jonas Jönmark, CEO of AcuCort.
The study is ongoing concurrently with the market launch and involves allergy patients being allocated Zeqmelit® for use when needed for the treatment of acute allergic reactions. The aim of the study, which is an open-label non-randomized low-intervention study, is to gather valuable data on the use of Zeqmelit® from patients who have previously been prescribed corticosteroids in tablet form for self-treatment of acute allergic reactions.
"So, it is not a study necessary for the launch since all clinical studies and approvals required are already in place, but a study showing how real patients experience Zeqmelit®," says Jonas Jönmark, CEO of AcuCort. "The initiation of the study supports the ongoing commercialization efforts and the upcoming market launch in the Nordic region," adds Jonas Jönmark.
Dr. Bahram Javizian, the physician and allergist who is the principal investigator for the study, elaborates on the purpose of the study:
"We want to gather patients' experiences of having this oral film, do they feel confident with it? How do they perceive using it? Perhaps the most important thing we are investigating is: Do patients carry the medication with them?" says Bahram Javizian.
The study's results are expected to be available by the end of 2024.
For further information:
Jonas Jönmark, CEO AcuCort AB
Tel: +46 70 3655400
Email: jonas.jonmark@acucort.se
About AcuCort AB (publ)
AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film placed on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly administration form primarily for the treatment of severe and acute allergic reactions, croup in children, nausea and vomiting during chemotherapy, and for the treatment of patients with COVID-19 requiring supplemental oxygen therapy. Zeqmelit® is approved in Sweden, Denmark, Norway, and Finland. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market. Visit www.acucort.se for more information.