Brisbane-based drug development company Invion (ASX:IVX) has announced completion of enrolment in its phase II clinical trial of INV102 (nadolol) in patients with mild asthma (NIMA).
The NIMA trial, which has been funded by the US National Institutes of Health (NIH), has 66 subjects randomised in accordance with the expanded target population for the study.
The last dose will be administered by the end of April 2016, followed by reporting of safety and efficacy, which will be assessed by impact on non-specific airway hyper-responsiveness (NSAHR) after six months’ therapy.
NIMA is a randomised double-blind placebo-controlled clinical trial designed to confirm improvements in NSAHR previously reported by Nicola Hanania, MD of Baylor College of Medicine, in two open-label trials of INV102 (nadolol).
In this current phase II trial, biomarker and bronchoscopy samples will also be analysed and reported. NIMA is being conducted at three academic centres: Baylor College of Medicine; Duke University; and, Washington University, St Louis.
Invion has responsibility for management of drug supply, management and compliance with the IND, and regulatory communications.
Executive Vice President R&D and Chief Medical Officer, Dr Mitchell Glass, said: “Completion of randomisation is a critical step in planning for study completion, statistical analysis and reporting. “NIMA has already provided important results concerning the safety of Invion’s proprietary titration scheme and of six months of nadolol treatment even in mild asthma patients with baseline NSAHR who are not on inhaled corticosteroids (ICS).
“While mild asthma is not ultimately a commercial target in Invion’s development plan, the demonstration of safety in these vulnerable patients strongly supports our goal of reversing the contraindication of nadolol - and thereby the introduction of nadolol to treat a wide range of airway diseases.
“We have already initiated dialogue with the NIH to follow NIMA with a study in moderate to severe asthma patients, utilising our inhaled formulation,” added Dr Glass.