FDA grants fast track designation to MN-001 for IPF

The FDA granted fast track designation to tipelukast for the treatment of patients with idiopathic pulmonary fibrosis, according to a press release from the drug’s manufacturer.

The FDA grants fast track designation to agents that demonstrate the potential to fill an unmet medical need related to the treatment of serious or life-threatening diseases or conditions.

Tipelukast (MN-001, MediciNova) — a novel, oral small-molecule compound — demonstrated anti-inflammatory and anti-fibrotic activity in preclinical models through leukotriene receptor antagonism, as well as inhibition of phosphodiesterases and 5-lipoxygenase.

The 5-lipoxygenase/leukotriene pathway is believed to be a pathogenic factor in development of fibrosis, so the inhibitory effects demonstrated by tipelukast may be a novel treatment approach, according to the press release.

Tipelukast has demonstrated potential to downregulate expression of several genes that promote fibrosis — including TIMP-1, LOXL2 and Collagen Type 1 — as well as downregulate expression of the CCR2 and MCP-1 genes, which promote inflammation.

The agent also has demonstrated the ability to reduce fibrosis in animal models, according to the press release.

“We are very pleased that MN-001 has received fast track designation for idiopathic pulmonary fibrosis and believe this validates its potential to address unmet medical needs in this life-threatening disease,” Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said in the press release. “We look forward to providing further updates as our development program progresses.”

MediciNova previously evaluated tipelukast in individuals with asthma, and the company reported positive phase 2 results.

More than 600 individuals have been treated with the agent, and it is considered well tolerated, company officials said.