MN-001, Potential Oral IPF Treatment, Likely to Claim Patent in Europe

The European Patent Office (EPO) has issued a “notice of intent” to grant a patent to MN-001 (tipelukast), MediciNova’s investigational oral therapy for idiopathic pulmonary fibrosis (IPF).

Once issued, the patent will cover the use of MN-001 in treating IPF, as well as in inhibiting lung scarring (fibrosis).

Other protected indications are to include the use of MN-001 for reducing hydroxyproline levels in the lungs (a marker of collagen deposition, associated with fibrosis), a lesser elevated lung density (detectable by abnormal opacity in chest X-rays), and reduced total cell counts in bronchoalveolar lavage fluid (high numbers of cells within this fluid are indicative of active inflammation and related damage or scarring).

Protection covers both MN-001 oral formulations, including tablets and capsules, as well as liquid forms.

Once granted, this potential therapy will stay under patent protection in Europe at least through May 2035.

“Previously, we were granted patents covering IPF in Japan and China, and now we are very pleased to receive notice that this new patent will be granted in Europe,” Yuichi Iwaki, MD, PhD, MediciNova’s president and CEO, said in a press release.

MN-001 (tipelukast) is a small molecule that has shown anti-inflammatory and anti-fibrotic activity in preclinical models. The molecule exerts such effects via different mechanisms, including the inhibition of the leukotriene (LT) receptor and 5-lipoxygenase (5-LO), as well as by blocking phosphodiesterases (PDE), all factors believed to underlie the development of fibrosis.

Because of MN-001’s inhibitory effect on 5-LO and LT, it is considered to be a new approach to treating fibrotic diseases.

Early evidence also suggests that MN-001 can lower the activation of genes that promote fibrosis and inflammation.

A Phase 2 clinical trial (NCT02503657) is ongoing to evaluate the safety and efficacy of MN-001 in adults with moderate to severe IPF. Those enrolled will be given MN-001 (750 mg dose) or a matching placebo twice daily for 26 weeks. The study plans to recruit up to 15 adult patients, and is expected to conclude in December 2020.

Recruitment is ongoing at a single site,  Penn State University College of Medicine. More information on eligibility criteria can be found here.

MediciNova previously evaluated MN-001 as a treatment for asthma, with positive Phase 2 results.

The U.S. Food and Drug Administration granted both orphan drug and fast-track designations to MN-001 as a potential IPF treatment. Orphan drug status offers MediciNova seven years of marketing exclusivity should the treatment be approved in the U.S.

The company reports on its website that this potential treatment has now been given to more than 600 people, and data indicate that it is generally safe and well-tolerated.