Potential IPF Oral Therapy, MN-001, Awarded Patent in China

MN-001, a potential treatment for idiopathic pulmonary fibrosis (IPF), will soon have patent protections in China.

MediciNova, the company developing MN-001 (tipelukast), received a Notice of Allowance from the Chinese Patent Office, which means that the company’s application fulfills all necessary requirements. Once issued, the patent is expected to run at least up to May 2035.

MN-001 is a small molecule thought to work via a number of different biological pathways, and to have anti-fibrotic and anti-inflammatory activity. In preclinical models, MN-001 reduced protein production from genes that promote fibrosis (scarring), such as LOXL2 and TIMP-1, as well as from genes that drive inflammation, including CCR2.

Besides as an IPF treatment, the patent will also cover the use of MN-001 to suppress scarring in the lungs, and to reduce or inhibit abnormally high levels of hydroxyproline — a major component of the collagen protein, which is overproduced in fibrotic tissue.

Other indications covered by the MN-001 patent are the potential therapy’s use to decrease elevated lung density, and to reduce the number of cells in bronchoalveolar lavage fluid within the lungs. (High numbers of detectable cells within this fluid indicate inflammation and related damage/scarring.)

The patent will broadly cover oral administration of MN-001, including tablet, capsule, and liquid forms of the investigative medication.

“We are very pleased to receive notice that this new patent will be granted as we believe it could substantially increase the potential value of MN-001,” Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said in a press release.

An ongoing Phase 2 clinical trial (NCT02503657), being funded by MediciNova, is evaluating MN-001’s safety and efficacy in up to 15 adults with moderate to severe IPF at a single site in Pennsylvania.

The study, expected to fully conclude in December 2020, includes a six-month double-blind period followed by a six-month open-label extension. Participants will receive either MN-001 (750 mg) or a placebo twice per day in the double-blind part, and all will be treated in the extension.

Its primary outcome measure is change in forced vital capacity, an assessment of lung function, at 26 weeks (six months). Other efficacy measures include testing the decline in disease activity, and differences in the 6-minute walk test (a test of exercise capacity).

The U.S. Food and Drug Administration granted both orphan drug and fast-track designation to MN-001 for the treatment of IPF.