MediciNova has concluded patient enrolment in its Phase 2 clinical trial (MN-221-CL-007) evaluating the safety and efficacy of MN-221, used for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD).
MN-221 is a highly selective beta(2)-adrenergic receptor agonist designed to treat acute exacerbations via intravenous infusion, bypassing constricted airways to deliver the drug directly to the lungs.
MN-221-CL-007 is a randomised double-blind placebo-controlled Phase 2 clinical trial that enrolled a total of 176 patients at around 20 sites in the US.
In the study, the primary efficacy endpoint is improvement in forced expiratory volume in one second (FEV1), while secondary endpoints include reduction in hospital admissions and changes in various clinical significances.
MN-221’s improved delivery to the lungs and its cardiac safety profile may help patients with asthma or COPD exacerbations, allowing them to breathe easier and avoid hospital stays.
Previous preclinical studies demonstrated that MN-221 showed high affinity for the beta(2)-adrenergic receptor, found primarily in the lungs, and a much lower affinity for the beta(1)-adrenergic receptor found primarily in cardiac tissue.
Currently, MediciNova is in the process of auditing the data and preparing to lock the database for a complete analysis, and anticipates releasing preliminary results in the second quarter of this year.
The company’s pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumour cancers, generalised anxiety disorder, preterm labour and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders.
MediciNova has acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical.