MSDC_0602



NAME OF DRUG : MSDC_0602

ALSO KNOWN AS : MSDC_0602

LABORATORY : CIRIUS_THERAPEUTICS

STATUS AND ADVANCEMENT

Type of drug : mTOT modulating insulin sensitizer

Clinical trials advancement : Ongoing Phase 2b

Estimated time to market : 98 months.

LABORATORY ABSTRACT ON THE DRUG

MSDC-0602, have been shown to effectively lower glucose without the same degree of unwanted and often unacceptable side effects experienced with current insulin sensitizers, including fluid retention, weight gain, heart failure, edema, and bone loss. In addition, these investigational new drugs have been shown in clinical and preclinical studies to have the potential to treat polycystic kidney disease and neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.

HISTORY AND ANALYSIS

Metabolic Solution is the initial promoter of MSDC-0602, they created OCTETA to develop the NASH / NAFLD segment.

The NASH treatment strategy proposed by OCTETA with their MSDC-0602 is interesting and could be very effective if it confirms its potential.

The molecules studied historically as the most effective against NASH are thiazolidinediones, particularly pioglitazone, a PPAR gamma agonist that has demonstrated in clinical studies amazing results in  a 30mg/d doses.

Unfortunately, at this level of dosage, side effects of pioglitazone are numerous: Weight gain, edema, bone fractures and increased risk of bladder cancer.

For this reason the PPAR gamma agonists have no good reputation and are no longer present in the race against NASH and used only at moderate dose in the treatment of diabetes (except sarotiglizar who is a combined light PPAR gamma agonist with a PPAR alpha agonist and is tested in a clinical studies in NASH, in India only).

Initially , METABOLIC SOLUTIONS studied a molecular  variation of the pioglitazone, the MSCD-0160 ( see the study results here) as mTOT insulin sensitizer.

 

To target NASH, METABOLIC SOLUTIONS develloped strategy is another kind of mTOT which would have less impact on the activation of PPAR gamma by modulating the TOT (mitochondrial target of thiazolidinediones) and would thus have the same effect on the regulation of  insulin sensitivity without side effects of already studied PPAR gamma agonists. Regulate NASH via insulin sensitizer is a promising pathway.  

A clinical Phase 2a was conducted for 28 days weeks comparing the effect of the MSDC-602 to the pioglitazone in a dose of 45 mg which is the highest dose permitted in treatment of diabetes.

The study included 127 patients ( 117 in results) with T2D and was divided in 4 arms :

  • Placebo
  • MSDC-0602 100 mg
  • MSDC-0602 250 mg
  • Pioglitazone

 

This study was not designed to evaluate any histological improvements on NASH but was targeting mainly the evolution of Fasting Plasma Glucose.

As secondary outcome mesures, the study mesured :

  • Change From Baseline in HbA1c 
  • Change From Baseline in Body Weight 
  • Change From Baseline in Hematocrit 
  • Change in Fasting Plasma Insulin 
  • Change From Baseline in High Molecular Weight Adiponectin

 

The full results of the study are not availables online yet but some results were presented by METABOLIC SOLUTIONS.

METSOLhttp://www.nashbiotechs.com/_Media/image-14.tiff

 

From that results, showing an impact of MSCD-0602 equivalent of pioglitazone on HBA1c and HMW Adipotectin levels, and regarding the positives results on NASH obtained by pioglitazone in a recent 18 months clinical study , METABOLIC SOLUTION extrapolate a potential positive effect of MSCD-0602 on NASH.

Undubitablelly  the MSCD-0602 TOT modulation could be a potential interesting strategy of treatment for NASH, but those esperances should be confirmed in a NASH dedicated clinical trial including histological enpoints.

The next step is a Phase 2b study on NASH started  in 2016 and curiously, behaving as primary endpoint the primary endpoint of the FLINT study of Intercept, ie a decrease of two points minimum score of NAFLD progression-free fibrosis. This is surprising because this criterion was criticized because of its poor correlation with NASH reversion. Their secondary enpoint is the one used by GENFIT for its Phase 3, the reversion of the NASH according to its new definition.

Investors should keep an eye on this Biotech, because if it passes the clinical studies and reach the market (not before 2025), the potential for its drug should make it an important player in the treatment of NASH.

 

RECENT NEWS ON MSDC_0602

SOME PUBLICATIONS RELATED WITH MSDC_0602

SOME NASHBIOTECHS POINTS OF VIEW RELATED WITH MSDC_0602

October 2016 : NASH COMBOs ARE THE WAY


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