MediciNova, Inc., a biopharmaceutical company developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs, recently announced that the US Food and Drug Administration has granted its leading product candidate for idiopathic pulmonary fibrosis (IPF) a Fast Track Designation. This follows the agency’s October 2014 decision to grant the product Orphan Drug Designation for IPF.
MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). With the new designation, MN-001 will be eligible for more frequent meetings with the FDA, accelerated approval, priority review, and a rolling review of its New Drug Application. All of these advantages ultimately means MN-001 is on a more rapid path to marketing approval and being in the hands of IPF patients nationwide.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased that MN-001 has received Fast Track Designation for IPF and believe this validates its potential to address unmet medical needs in this life-threatening disease. We look forward to providing further updates as our development program progresses.”
MediciNova has also recently been in the news for making progress on developing MN-166, also called Ibudilast, as part of a study on the management of ALS. The company announced that they have enrolled the first participant in a new study that will include 80 participants, including advanced ALS patients, who will receive MN-166 along with an existing drug, riluzole. In response to their ALS study, Iwaki commented, “We are very pleased to have successfully completed the FDA review period, which allows us to enroll the first advanced ALS patient with NIV support. The safety and efficacy data from advanced ALS patients will be important for our development efforts in ALS and is complementary to the ongoing study that is enrolling ALS patients who are not using NIV.”
In other PF drug development news, a currently recruiting Phase 2 clinical trial from Sanofi, “Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR),” will be investigating how a novel antibody treatment may help patients with idiopathic pulmonary fibrosis (IPF). The novel therapeutic, SAR156597, will be tested against a placebo to determine if it is efficacious in improving lung function in patients with IPF.
An estimated 300 patients will enroll in the study, which began in May 2015. Sanofi estimates the trial will be completed in July of 2017, at which time they will conduct the final data collection for primary efficacy outcomes. Thereafter, data analysis will indicate if SAR156597 is a promising treatment for patients with IPF.