Update on Phase IV Study: 40 of 50 Patients Recruited
AcuCort's Phase IV study ZEQ001 for Zeqmelit® is ongoing. 40 patients have been assigned the oral film for use when needed for acute allergic reactions.
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 collect scientific data on patient usage of Zeqmelit®. The results will be published in scientific journals to enhance the product's marketing. The recruitment of patients for the study meets AcuCort's high expectations, with 40 patients, out of 50 in total, currently enrolled.
"It's always a challenge to recruit patients for drug studies. It's gratifying that our study has already recruited 40 patients in a short time, demonstrating the high interest in the product among allergy patients," says Jonas Jönmark, CEO of AcuCort.
The study is running concurrently with the product's market launch in the Nordic region, where allergy patients are provided Zeqmelit® for use when needed for acute allergic reactions. The purpose of the study, an open-label non-randomized low-intervention trial, is to gather valuable scientific data on Zeqmelit® usage from patients previously prescribed corticosteroids in tablet form for self-treatment of acute allergic reactions. The study's results are expected by the end of 2024.
"The study aims to show how real patients experience using Zeqmelit®. We believe the scientific findings will be a crucial part of the marketing and upcoming market launches," says Jonas Jönmark, CEO of AcuCort.
Dr. Bahram Javizian, the principal investigator of the study and allergist, elaborates on the study's purpose:
"We want to understand patients' experiences with this biofilm, such as feeling safe with it, their experience using it, and importantly, whether 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.