MediciNova will initiate a Phase 2 clinical trial of MN-001 (tipelukast) to treat moderate to severe idiopathic pulmonary fibrosis (IPF).
What is IPF?
IPF is a disease in which tissue deep in your lungs becomes thick and stiff, or scarred over time causing an irreversible loss of the tissue's ability to transport oxygen.
“It essentially turns balloons into lead bricks,” said Imre Noth MD, director of the interstitial lung disease program at University of Chicago Medicine. “Eventually the lungs fail. It’s a systemic disease that starts from the outside of the lung.”
The disease effects 47 per 100,000 patients. Patients can be diagnosed with a modern CT scan.
“The CT scan shows what is called ‘honeycombing’,” said Noth. “That’s where the scar is pulled apart and creates small holes.”
According to Noth, a phase 2 trial is a big deal for IPF. Previous treatments up to a year ago only included a lung transplant.
“That only helps about 5% of those that actually got it because there is only so many transplants to go around. Then you trade one problem for another. The survival for transplant is only about 50% over 5 years so that has its own set of problems,” said Noth.
The Phase 2 trial is a double blind 6-month study followed by an open-label extension phase to evaluate the efficacy, safety and tolerability of MN-001 of patients with moderate to severe IPF.
Approximately fifteen qualifying patients will be randomly assigned in a 2:1 ratio to MN-001 750 mg or matching placebo orally administered twice a day for 26 weeks.
After completion of the double-blind treatment phase, patients will participate in the open-label extension (OLE) phase for an additional 6 months. Patients who were in the placebo group will be administered MN-001 750 mg twice a day for remainder of the OLE Phase.
Patients randomized to the MN-001 group will continue on MN-001 for additional 6 months. A follow-up visit will occur within 4 weeks after last dose.
The primary efficacy endpoints of the study are to evaluate the effect of MN-001 on 1) change from baseline of forced vital capacity (FVC) and FVC percent predicted up to 26 weeks, and 2) the semiannual rate of decline of disease activity based on forced vital capacity (FVC).
Secondary endpoints include safety and tolerability, semiannual rate of decline on disease activity based on the 6-minute walk test (6MWT), change from baseline on disease activity based on Modified Medical Research Council Dyspnea Score (MMRC), change from baseline on quality of life (QOL) measured by A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF), frequency of worsening IPF and time to first worsening of IPF.
Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said in a press release, “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 further commented “MN-001 development is addressing an unmet medical need in targeting the most severely afflicted IPF patients.”
MediciNova to Initiate Clinical Trial of MN-001 (tipelukast) in IPF [news release]. La Jolla, CA: MediciNova, Inc.: October 9, 2015. http://globenewswire.com/news-release/2015/10/09/774889/0/en/MediciNova-to-Initiate-Clinical-Trial-of-MN-001-tipelukast-in-IPF.html