MediciNova, Inc. announced the progression of MN-001 (tipelukast), a small molecule drug to treat idiopathic pulmonary fibrosis (IPF), into phase II clinical trials. This development follows the culmination of the agreement between MediciNova, Inc. and Penn State University with Principal Investigator Dr. Rebecca Bascom, and completion of an IRB (Institutional Review Board) review.
IPF is a type of interstitial lung disease that affects the tissue that supports the alveoli in the lung, characterized by the inflammation or accumulation of scar tissue and denominated fibrosis in the lung, leading to failure of proper lung activity. The term “idiopathic” relates to disease cases where the cause is unknown.
MN-001 (tipelukast) is a small molecule developed to treat fibrotic disorders such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). It has previously been shown to be safe and well tolerated. Tipelukast has exerted anti-inflammatory and anti-fibrotic activity in several preclinical animal models by inhibiting pathways involved in fibrosis and down-regulating genes involved in inflammation. The FDA has granted orphan drug designation to MN-001 for IPF treatment.
The recently FDA-approved Phase II trial will be placebo-controlled and include 15 randomly selected patients, orally administered randomly with MN-001 / placebo, twice a day for 26 weeks. The trial will be followed by an open-label extension period of 6 months to further evaluate safety, efficacy and tolerability. The main objectives of this trial are to determine the drug’s effect on forced vital capacity (FVC) and rate of disease decline. Safety, tolerability, quality of life and IPF disease progression are also important goals for this study.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented on the exciting news, stating: “We are very pleased to have completed the IRB review period and the agreement with Penn State and look forward to initiating patient enrollment this Fall.” Dr. Iwaki also highlighted the treatment’s potential “MN-001 development is addressing an unmet medical need in targeting the most severely afflicted IPF patients.”