Iconovo's partner Amneal has taken the next important step in the clinical development of ICOres® budesonide/formoterol
Iconovo AB (publ), a leader in the development of inhalable drugs based on proprietary inhalers and dry powder formulations, today announces that the company's development partner Amneal Pharmaceuticals has completed a clinical pharmacokinetic pilot study comparing ICOres® budesonide/formoterol and Symbicort® Turbuhaler®. The results from the study indicate that ICOres® budesonide/formoterol will meet the criteria for demonstrating bioequivalence in an appropriately designed and powered study. The study represents an important step ahead of the initiation of a registration study of the product and Iconovo will proceed according to plan.
In this exploratory pharmacokinetic study, comparing two ICOres® budesonide/formoterol product variations with the reference product, Symbicort® Turbuhaler®, the comparative bioavailability of all three products was shown to be very similar. Given this successful outcome, ICOres® budesonide/formoterol is expected to meet the strict criteria for demonstrating bioequivalence in an appropriately designed and powered study.
The study was conducted in 24 healthy individuals with a single-dose crossover design. In order to more effectively identify which formulation composition is needed to achieve bioequivalence in a registration study, two arms with different compositions were investigated. The different compositions in the ICOres® inhaler were compared with those of a control arm with Symbicort® Turbuhaler®.
"We are pleased that our partner, the publicly listed U.S. pharmaceutical company Amneal Pharmaceutials, has taken this important step forward in the clinical development of ICOres® budesonide/formoterol. The results from this study have provided the final piece of the puzzle to move forward with a pivotal study according to plan," says Iconovo's CEO, Johan Wäborg.
ICOres® budesonide/formoterol is based on Iconovo's innovative proprietary dry powder inhaler. It is being developed by Amneal Pharmaceuticals as a generic version of Symbicort® Turbuhaler®, a well-established treatment for asthma and COPD. Symbicort® had sales of USD 2.4 billion in 2023 of which 60-70% is derived from the Turbuhaler inhaler. Amneal has in-licensed the global rights to ICOres® budesonide/formoterol, while Iconovo intends to market the product in the Nordic region. Iconovo's royalty on Amneal's sales of ICOres® budesonide/formoterol amounts to between 5 and 10 percent.
The clinical development of ICOres® budesonide/formoterol encompasses a number of pilot pharmacokinetic studies that are performed sequentially to optimize the product for a final registration study, a pivotal pharmacokinetic study, with the potential to demonstrate its equivalence to Symbicort® Turbuhaler®. When positive results have been achieved from such a pivotal pharmacokinetic study, the product can enter the regulatory approval process.