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NASH Space in Focus as Galmed (GLMD) Posts Positive Data

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The NASH or the non-alcoholic steatohepatitis space is back in focus as Israel-based Galmed Pharmaceuticals (GLMD - Free Report) reported positive data on its candidate, Aramchol. The candidate demonstrated statistically significant reduction in liver fat at 52 weeks. A larger number of patients treated with Aramchol 600mg showed NASH resolution without worsening of fibrosis in the 52-week biopsy.  This encouraging data boosted investor sentiment, leading to the stock’s significant surge.

Of late, the NASH space has been under the spotlight given its market potential.  The market for NASH is poised to witness rapid growth unlike other lucrative yet saturated markets like cancer.

What is NASH?

A chronic liver disease, NASH is caused by excessive fat accumulation in the liver, known as steatosis. Per records, it has affected up to 15 million people in the United Stated and could cause inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. The ailment is anticipated to be the leading reason behind liver transplantation by 2020. Currently, NASH induces the biggest basis for liver transplants in people under 50 in the United States. Such patients also suffer obesity and type II diabetes.

With no treatments currently approved to address this disease, the market opportunity is substantially huge and many companies are investing a major chunk of their R&D spend in the same.

Let us consider the companies with potential candidates presently being evaluated for the treatment of NASH.

5 Stocks With Promising NASH Candidates in Their Pipeline

Madrigal Pharmaceuticals (MDGL - Free Report) : Shares of Madrigal Pharmaceuticals soared last month after the company reported positive top-line, 36-week results from a phase II trial on patients with biopsy-proven NASH. The program evaluated the lead pipeline candidate, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) β-selective agonist. Data from the study showed that MGL-3196 achieved higher reduction in NAFLD activity score (NAS) and greater NASH resolution in patients with 30% or more liver fat reduction achievement at week 12. The candidate had met the primary endpoint of 30% or more reduction in liver fat at week 12 last December. The company will advance the candidate to a phase III study following a regulatory agreement on its design.

Madrigal’s stock has skyrocketed 303.3% in the last six months, outperforming the industry’s rise of 9.2%. The company currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

 

Gilead Sciences Inc. ((GILD - Free Report) ): Biotech bigwig Gilead is also foraying into the emerging NASH domain with its late stage candidate, selonsertib, to combat the persistent decline in its one-time lucrative HCV business. In April 2018, the company announced encouraging data from a proof-of-concept study of experimental combination therapies for patients with advanced fibrosis due to NASH. Apoptosis signal-regulating kinase 1 (ASK1) inhibitor, selonsertib, was combined with either the Acetyl-CoA carboxylase (ACC) inhibitor, GS-0976, or the selective, non-steroidal Farnesoid X receptor (FXR) agonist, GS-9674, as therapies. Gilead’s NASH pipeline includes selonsertib, GS-9674 and GS-0976, alone and in combination with one other. Favorable results suggest that the combination therapy with selonsertib and either GS-0976 or GS-9674 can be evaluated further in patients with NASH and F3 and F4 fibrosis. 

Gilead’s stock has lost 3.5% in the last six months compared with the industry's decline of 6.2%.

 

Intercept Pharmaceuticals, Inc. (ICPT - Free Report) : Intercept is another company, pumping its resources into the NASH space. The company is evaluating its lead candidate, obeticholic acid (OCA), for treating NASH. OCA achieved the primary endpoint in a phase IIb trial (FLINT). Currently, a phase III study, REGENERATE, among non-cirrhotic NASH patients with liver fibrosis is ongoing. Top-line results from its interim analysis are expected in the first half of 2019. Intercept also initiated a phase III trial, REVERSE, on OCA.  The randomized phase III study will examine the efficacy and safety of OCA on subjects with compensated cirrhosis due to NASH in approximately 540 patients with a biopsy-confirmed diagnosis of cirrhosis. Intercept expects to submit marketing authorization for OCA as a treatment option for NASH patients with compensated cirrhosis in the United States and international markets on the basis of the positive results from the study. A subsequent outcome trial is also in the cards to confirm the clinical benefit on a post-marketing basis across a broader population of NASH patients with cirrhosis. OCA is already approved as Ocaliva in combination with ursodeoxycholic (UDCA) for the therapy of primary biliary cholangitis (PBC) in adults with an inadequate response to UDCA or as a monotherapy in adults unable to recuperate with UDCA.

Intercept’s stock has surged 32.6% over a year versus the industry's decline of 6.2%.

 

Conatus Pharmaceuticals Inc. (CNAT - Free Report) : Conatus also has a promising NASH candidate in its pipeline. The company is developing emricasan, a first-in-class, orally active pan-caspase protease inhibitor, for the treatment of patients with chronic liver disease. Conatus currently has three ongoing studies, namely ENCORE-PH, ENCORE-NF and ENCORE-LF, evaluating emricasan for NASH patients. The company has a collaboration agreement with Swiss major Novartis for the global development and commercialization of products containing emricasan either as a single active ingredient or in combination with other Novartis compounds for liver cirrhosis or liver fibrosis. Although emricasan failed in a phase IIB study — POLT-HCV-SVR — when it did not achieve the primary endpoint in patients with fibrosis or cirrhosis undergoing liver transplant, investors will still keenly follow data from multiple NASH studies.  Data from the ongoing trials are likely to be received by this year-end and 2019. A positive outcome will surely boost growth prospects for the company.

The company currently carries a Zacks Rank #3 (Hold). Conatus’ stock has rallied 25.7% in the last six months, outperforming the 11.3% increase recorded by the industry.

 

Galectin Therapeutics Inc. (GALT - Free Report) is another company with a late stage NASH candidate, GR-MD-02. The candidate is a carbohydrate-based drug inhibiting the galectin-3 protein, directly involved in multiple inflammatory, fibrotic and malignant diseases. The lead development program is in NASH with cirrhosis, the most advanced form of NASH related fibrosis. In May, the company announced that it will initiate a phase III trial with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained from a meeting with the FDA.  The target population of the trial comprises patients with NASH cirrhosis without esophageal varices.

Galectin currently carries a Zacks Rank #3 (Hold). Its stock has gained by a staggering 227.2% in the last six months, outperforming the industry’s growth of 9.4%.

 

Bottom Line

Riding high on the vast market potential, other big multiple pharma and biotech companies too produce pipeline candidates for the treatment of NASH. Hence, we expect a lot of activity in this specific space going forward. A potential approval of any drug for NASH will attract more players.

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