Apeiron Biologics is preparing to study an inhaled formulation of its ACE2 receptor decoy APN01. The clinical trial will test whether switching from intravenous to inhaled delivery can expand the patient population for the COVID-19 candidate.
Vienna-based Apeiron began studying APN01 in COVID-19 in the belief the soluble form of ACE2 may stop the coronavirus from entering human cells. The idea is that the molecule could serve as a decoy receptor, reducing ACE2-mediated entry into cells, while also acting on a peptide system involved in blood pressure, inflammation and the prevention of organ damage.
A phase 2 clinical trial of APN01 in hospitalized COVID-19 patients missed its primary endpoint earlier this year, but Apeiron has continued to forge ahead, securing a spot on the National Institutes of Health-backed ACTIV-4d trial and hatching plans to run its own study of an inhaled formulation.
“Delivery of our drug candidate directly to the respiratory tract could block viral entry into the lung cells and control inflammation. Importantly, APN01 may also be suitable against infections with variants of SARS-CoV-2 as already preclinically shown,” Romana Gugenberger, Apeiron’s head of R&D, said in a statement.
Apeiron plans to start the inhalation study in the third quarter. The change of delivery routes reflects a belief that inhalation could enable Aperion “to target all infected or at-risk patients earlier in the course of the disease.” Apeiron said ACE2-based therapeutics have shown “high efficacy” in animal models. The company is planning a financing round to fund development.
Work on the intravenous formulation of APN01 is continuing with external support. The Vanderbilt Institute for Clinical and Translational Research has included the drug in ACTIV-4d, a 1,600-subject study that is assessing multiple therapies that may restore the renin angiotensin aldosterone system in COVID-19 patients.