Update on Phase 4 Study: 25 Patients Recruited
AcuCort's Phase IV study ZEQ001 for Zeqmelit® is ongoing. 25 patients have been assigned the oral film for use when treatment for acute allergic reactions is needed.
As previously communicated, the Phase IV study ZEQ001 concerning the oral film Zeqmelit® commenced at the end of January. The purpose of the study is to gather scientific data on patient usage of Zeqmelit®. The results will be published in scientific journals and enhance the product's marketing. The recruitment of patients for the study meets AcuCort's high expectations. Already, approximately 1.5 months in, 25 allergy patients are enrolled in the study, which is intended to include a total of 50 patients.
"It's always a challenge to recruit patients for drug studies. It's gratifying that our study has recruited 25 patients in a short time, demonstrating the high interest in the product among allergy patients," says Jonas Jönmark, CEO of AcuCort.
The study is being conducted concurrently with the product launch in the Nordic region and entails allergy patients being assigned Zeqmelit® for use when needed for the treatment of acute allergic reactions. The purpose of the study, which is an open-label non-randomized low-intervention study, is to gather valuable scientific data on the usage of Zeqmelit® from patients who have previously been prescribed corticosteroids in tablet form for self-treatment of acute allergic reactions. The study's results are expected to be available by the end of 2024.
"The study will demonstrate how real patients perceive the use of Zeqmelit®. We believe that the scientific results will be an important part of the marketing and upcoming product launches," says Jonas Jönmark, CEO of AcuCort.
Dr. Bahram Javizian, the physician and allergist who is the principal investigator for the study, elaborates on the study's purpose:
"We want to gather patients' experiences of having this biofilm, for example: do they feel confident with it? How do they perceive using it? Perhaps the most crucial aspect we're investigating is: Do patients carry the medication with them?" says Bahram Javizian.
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.