LA JOLLA, CA, USA I August 5, 2014 I MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a second preclinical study that examined the potential clinical efficacy of MN-001 for the treatment of advanced NASH (nonalcoholic steatohepatitis with fibrosis).
This study used mice in more advanced stages of NASH as compared to the first study of MN-001 in a NASH mouse model. MN-001 administered orally once daily (10, 30, and 100 mg/kg) for 4 weeks, was evaluated in the STAM(TM) (NASH-HCC) mouse model of advanced NASH, as measured by histopathology, NAFLD activity score (NAS) and percent of fibrosis.
MN-001 showed anti-NASH and anti-fibrotic effects in the advanced NASH mouse model. NAFLD activity score was significantly reduced in the MN-001 treated group compared to the non-treated group (p<0.001). The reduction was observed consistently in all NAS components including hepatocyte ballooning score (p<0.001), lobular inflammation score (p<0.01), and steatosis score (p<0.05). Percent fibrosis area was also reduced in the MN-001 treated group (p<0.01). In addition, alpha-SMA-positive staining area was significantly reduced in the MN-001 treated group (p<0.001).
Based on these results in addition to the results of the first NASH mouse model study reported on January 14, 2014, MediciNova requested a meeting with FDA to finalize the trial design for a clinical study of MN-001 in NASH patients.
About NASH (nonalcoholic steatohepatitis)
Nonalcoholic steatohepatitis (NASH) is a condition in which there is fat in the liver along with inflammation and damage to liver cells. NASH is a common liver disease that resembles alcoholic liver disease but occurs in people who drink little or no alcohol. According to the U.S. National Digestive Diseases Information Clearinghouse (NDDIC), NASH prevalence in the U.S. is 2-5%, and an additional 10-20% of Americans have “fatty liver.” The underlying cause of NASH is unclear, but it most often occurs in persons who are middle-aged and overweight or obese. Many patients with NASH have elevated serum lipids, diabetes or pre-diabetes. Progression of NASH can lead to liver cirrhosis. Liver transplantation is the only treatment for advanced cirrhosis with liver failure. At this time, there is no treatment for NASH.
About MN-001
MN-001 is a novel, orally bioavailable small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) 3 and 4, and inhibition of 5-lipoxygenase (5-LO). It is postulated that inhibition of the 5-LO pathway exerts anti-inflammatory actions, which has implications in various inflammatory diseases such as arthritis, osteoarthritis, and allergy. Recently, 5-LO has been postulated as a pathogenic factor in fibrotic changes. MN-001’s inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis.
Previously, MediciNova evaluated MN-001 for its potential clinical efficacy in asthma and had positive Phase 2 results. MN-001 has been exposed to more than 600 subjects and is considered generally safe and well-tolerated.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders, MN-221 for the treatment of acute exacerbations of asthma, and MN-001 for NASH and IPF. MN-166 is being developed in multiple indications, largely through investigator-sponsored trials and outside funding. MediciNova is engaged in strategic partnering discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.
SOURCE: MediciNova
Post Views: 75
LA JOLLA, CA, USA I August 5, 2014 I MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a second preclinical study that examined the potential clinical efficacy of MN-001 for the treatment of advanced NASH (nonalcoholic steatohepatitis with fibrosis).
This study used mice in more advanced stages of NASH as compared to the first study of MN-001 in a NASH mouse model. MN-001 administered orally once daily (10, 30, and 100 mg/kg) for 4 weeks, was evaluated in the STAM(TM) (NASH-HCC) mouse model of advanced NASH, as measured by histopathology, NAFLD activity score (NAS) and percent of fibrosis.
MN-001 showed anti-NASH and anti-fibrotic effects in the advanced NASH mouse model. NAFLD activity score was significantly reduced in the MN-001 treated group compared to the non-treated group (p<0.001). The reduction was observed consistently in all NAS components including hepatocyte ballooning score (p<0.001), lobular inflammation score (p<0.01), and steatosis score (p<0.05). Percent fibrosis area was also reduced in the MN-001 treated group (p<0.01). In addition, alpha-SMA-positive staining area was significantly reduced in the MN-001 treated group (p<0.001).
Based on these results in addition to the results of the first NASH mouse model study reported on January 14, 2014, MediciNova requested a meeting with FDA to finalize the trial design for a clinical study of MN-001 in NASH patients.
About NASH (nonalcoholic steatohepatitis)
Nonalcoholic steatohepatitis (NASH) is a condition in which there is fat in the liver along with inflammation and damage to liver cells. NASH is a common liver disease that resembles alcoholic liver disease but occurs in people who drink little or no alcohol. According to the U.S. National Digestive Diseases Information Clearinghouse (NDDIC), NASH prevalence in the U.S. is 2-5%, and an additional 10-20% of Americans have “fatty liver.” The underlying cause of NASH is unclear, but it most often occurs in persons who are middle-aged and overweight or obese. Many patients with NASH have elevated serum lipids, diabetes or pre-diabetes. Progression of NASH can lead to liver cirrhosis. Liver transplantation is the only treatment for advanced cirrhosis with liver failure. At this time, there is no treatment for NASH.
About MN-001
MN-001 is a novel, orally bioavailable small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) 3 and 4, and inhibition of 5-lipoxygenase (5-LO). It is postulated that inhibition of the 5-LO pathway exerts anti-inflammatory actions, which has implications in various inflammatory diseases such as arthritis, osteoarthritis, and allergy. Recently, 5-LO has been postulated as a pathogenic factor in fibrotic changes. MN-001’s inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis.
Previously, MediciNova evaluated MN-001 for its potential clinical efficacy in asthma and had positive Phase 2 results. MN-001 has been exposed to more than 600 subjects and is considered generally safe and well-tolerated.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders, MN-221 for the treatment of acute exacerbations of asthma, and MN-001 for NASH and IPF. MN-166 is being developed in multiple indications, largely through investigator-sponsored trials and outside funding. MediciNova is engaged in strategic partnering discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.
SOURCE: MediciNova
Post Views: 75
