MN 001: KCA 757, KCA-757, MN-001

MN 001 is an orally bioavailable anti-inflammatory agent, originated by Kyorin Pharmaceutical, which is being developed in clinical trials by the US company MediciNova for the treatment of interstitial cystitis and asthma. Kyorin is developing the drug as KCA 757 for these indications. The actions of the drug are described by MediciNova as consisting of eosinophil migration inhibition, leukotriene antagonism, and phosphodiesterase IV inhibition. Other mechanisms described for MN 001 include the inhibition of phosphodiesterases III, 5-lipoxy-genase, phospholipase C as well as thromboxane A2. Development of an immediate-release formulation of MN 001 has been discontinued. An extended-release formulation remains in development. MediciNova is looking for partnering/outlicensing opportunities for MN 001 in North America and Europe. MediciNova licensed MN 001 from Kyorin Pharmaceutical in March 2002, and now holds exclusive worldwide rights, excluding Japan, China, Taiwan and South Korea, to develop and commercialise the drug. The phase III clinical programme of immediate-release MN 001 was initiated by Medicinova in the US in November 2006. In the first phase III trial, 705 patients with mild to moderate asthma were to be randomised to receive MN 001 (750 mg twice daily, 500 mg three times daily) or placebo for 12 weeks. The change from baseline in mean forced expiratory volume in 1 second (FEV(1)) will be the primary endpoint. The primary endpoint was met in a phase II study of MN 001 in patients with mild to moderate asthma. The trial evaluated the efficacy of three different doses of MN 001 for the treatment of asthma. Results have been reported. MediciNova has received Notices of Allowance from the US Patent and Trademark Office for three patent applications covering certain compositions, uses and manufacturing processes associated with MN 001. MN 001 has received patent protection through at least 2023.