Document Detail


MN 001: KCA 757, KCA-757, MN-001.
MedLine Citation:
PMID:  17963431     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
-
Publication Detail:
Type:  Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Drugs in R&D     Volume:  8     ISSN:  1174-5886     ISO Abbreviation:  Drugs R D     Publication Date:  2007  
Date Detail:
Created Date:  2007-10-29     Completed Date:  2008-02-11     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  100883647     Medline TA:  Drugs R D     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  400-2     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Airway Obstruction / drug therapy
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Asthma / drug therapy
Butyric Acids / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Drugs, Investigational / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Female Urogenital Diseases / drug therapy
Humans
Respiratory Function Tests
Sulfides / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Chemical
Reg. No./Substance:
0/4-(6-acetyl-3-(3-(4-acetyl-3-hydroxy-2-propylphenylthio)propoxy)-2-propylphenoxy)butyric acid; 0/Anti-Inflammatory Agents, Non-Steroidal; 0/Butyric Acids; 0/Drugs, Investigational; 0/Sulfides

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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