MediciNova, Inc., a publicly-traded biopharmaceutical company working on developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs, recently announced that it is in late-stage discussions with researchers at Penn State University (lead researcher Dr. Rebecca Bascom) to begin a Phase 2 clinical trial of MN-001 (tipelukast) for the treatment of moderate to severe idiopathic pulmonary fibrosis (IPF).
The trial is a double blind, placebo controlled, randomized, 6-month Phase 2 clinical study followed by an open-label extension period that will assess the safety, tolerability and efficacy of MN-001 in patients with a diagnosis of moderate to severe IPF. 15 patients will be randomized to receive MN-001 (750 mg) or a matching placebo given orally twice per day for a period of 26 weeks (double-blind phase).
Following this, IPF patients will take part in the open-label extension (OLE) study period for more 6 months. Patients who were in the study’s placebo arm will be given MN-001 (750 mg) twice per day for the rest of the OLE study period. Patients who were in MN-001 study arm will continue to receive treatment with MN-001 for more 6 months. After the last dose, patients will be followed-up within 4 weeks.
The study’s primary efficacy outcomes involve the analysis of the effect of MN-001 on the semiannual rate of decline of disease activity assessed with the forced vital capacity (FVC), the baseline change of forced vital capacity (FVC) and the FVC% predicted for a period of up to 26 weeks.
The study’s secondary outcomes involve the tolerability and safety of the drug, worsening of IPF frequency, baseline change on disease activity assessed with the Modified Medical Research Council Dyspnea Score (MMRC), baseline change on quality of life (QOL) assessed by A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF), the semiannual decline rate on disease activity measured with the 6-minute walk test (6MWT), and time to first worsening of IPF.
MN-001 has already been granted with FDA orphan-drug designation for IPF. This gives MediciNova a period of seven years for exclusive marketing if MN-001 is approved for the treatment of patients with IPF.
Tipelukast (MN-001) is an oral macromolecular formulation developed originally by Kyorin Pharmaceuticals, now being tested for clinical trials in the United States by MediciNova after acquiring licensing rights back in 2002. MediciNova was recently granted an official license to commercially manufacture and sell the drug worldwide except in Japan, China, Taiwan and South Korea. The drug has also received patent protection until 2023.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented in a recent press release, “We are very pleased that discussions are moving forward as planned with our potential study investigators. The study design for this trial includes severe IPF patients, which we believe have never been included in any other IPF clinical studies.”