A Japanese agency has cleared MediciNova’s request for a patent covering the use of its orally available candidates MN-001 (tipelukast) and MN-002 — a major metabolite of MN-001 — in treating idiopathic pulmonary fibrosis (IPF).
The company announced it has received a Notice of Allowance from the Japan Patent Office, meaning that its application fulfills all necessary requirements. Once issued, the patent is expected to run at least until May 2035.
This new patent mirrors protections recently given MN-001 as IPF therapy through a patent approval in China.
These patents not only cover the use of MN-001 for the treatment of IPF, but also as a therapy to prevent tissue scarring (fibrosis) in the lungs, and to reduce or inhibit abnormally high levels of hydroxyproline — a major component of the collagen protein that is excessively produced and accumulates in fibrotic tissue.
Other indications covered by the patents are the potential use of MN-001 or MN-002 to both lower high lung density (detectable by abnormal opacity in chest X-rays) and total cell counts in bronchoalveolar lavage fluid (high numbers of cells within this fluid are indicative of active inflammation and related damage or scarring).
The patents will broadly cover oral administration of these therapies, if approved for use, in different formulations, including as tablets, capsules, and liquids.
“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 the press release.
MN-001 is a small molecule believed to act on several different biological pathways, having anti-fibrotic and anti-inflammatory activity. In animal models of IPF, this investigational therapy has shown to effectively reduce the production of proteins known to be involved in fibrosis, as well as to prevent the activity of genes that can drive inflammation.
The U.S. Food and Drug Administration granted both orphan drug and fast-track designation to MN-001 as a potential Idiopathic Pulmonary Fibrosis (IPF) treatment.
The safety and efficacy of MN-001 is being evaluated in an ongoing Phase 2 clinical trial (NCT02503657), conducted at a single site in Pennsylvania, in 15 adults with moderate to severe IPF. The study is expected to conclude in December 2020.
Researchers are evaluating the treatment’s impact on patient’s respiratory function, as determined by changes in forced vital capacity. They will also assess other effectiveness measures, such as changes in disease activity and exercise capacity