The race is on to get a commercial biotech treatment asset targeting Nonalcoholic steatohepatitis, or “NASH”.
NASH is sadly one of the fastest growing treatable major health problems on the planet right now, and analysts believe the resulting commercial opportunity could be as big as $20-35 billion annually by midway through this decade.
NASH is a form of nonalcoholic fatty liver disease that results in severe inflammation and organ damage to the liver. It can develop into cirrhosis in many cases. In those cases, without treatment, it can lead to liver failure, liver cancer, or death.
In other words, it’s a huge and rapidly growing market opportunity (with a CAGR possibly approaching 60% over the next 5 years, according to Allied Market Research forecasts) that is a clear need with currently no FDA approved highly effective commercial-stage solutions.
The winner in this race will be a huge story in the biotech space. But the competition is fierce. For investors, it could represent a major opportunity. With that in mind, we take a look at some of the most interesting names in this race and explore recent catalysts.
Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) engages on the development and commercialization of innovative therapeutic candidates for the treatment of cardiovascular, metabolic, and liver diseases.
The company’s lead product, MGL-3196, is used for the treatment of NASH and familial hypercholesterolemia.
Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) recently announced its support of the Fatty Liver Foundation, the leading patient advocacy organization focused on the diagnosis, treatment and support of Americans with non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH).
Paul Friedman, CEO of Madrigal said, “In recognition of Liver Awareness Month, we want to highlight the high unmet need of the millions of Americans who suffer from NAFLD and NASH. NASH is known as a ‘silent disease’ because many people don’t know they have it until it has progressed to a dangerous stage. By supporting FLF, our objective is to improve the medical and patient community’s understanding of the disease, better identify NAFLD/NASH patients, and communicate the growing body of clinical evidence demonstrating the utility of non-invasive tools and techniques to screen and diagnose patients.”
The stock has suffered a bit of late, with shares of MDGL taking a hit in recent action, down about -7% over the past week. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -9%.
Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($323.8M against $56.7M).
Adhera Therapeutics Inc (OTCMKTS:ATRX) is the newest entrant into this race, which makes the stock particularly interesting as shares of ATRX haven’t priced in any of this potential because the company just made its announcement about an asset targeting NASH treatment this week. And it’s even more interesting than that because it’s a licensed asset that has already shown promising potential for treating NASH, including having a clean bill of health on the safety side.
For a little background, the company is already making strides in both the Parkinson’s and Diabetes markets through its licensing of two promising compounds, MLR-1019 (armesocarb) and MLR-1023 (tolimidone), from Melior Pharmaceuticals for development, using its own expertise.
Adhera Therapeutics Inc (OTCMKTS:ATRX) further advanced that story this week with its announcement that it has extended its relationship with Melior through the addition of exclusive development rights for two more indications to the existing licensing agreement covering MLR-1023 (tolimidone), one of the world’s only potent and specific lyn kinase activators.
According to its release, Adhera has now been granted exclusive rights to advance development of MLR-1023 for NASH as well as pulmonary inflammation. The company noted that it intends to explore abbreviated clinical trial opportunities for these indications based upon completed clinical trials including more than 700 patients treated with MLR-1023 defining strong safety and tolerability profiles. That suggests it is already potentially further along in the NASH race than many competitors without the market having had any means to discount that progress through upside share repricing.
MLR-1023 has reportedly produced compelling data to date, including improvement in NAFLD (Non-alcoholic fatty liver disease) Activity Score, or NAS, decreased liver weight, reduction in steatosis, improved insulin sensitivity, anti-fibrotic activity, and reduction in adiposity. Other research on MLR-1023 by independent investigators has revealed modulation of lipid pathways to reduce fat accumulation in the liver and improved cell survival and hepatocellular regeneration, lending further evidence that clinical studies are warranted for the indication.
Adhera Therapeutics Inc (OTCMKTS:ATRX) CEO, Andrew Kucharchuk, stated in the release, “MLR-1023 is a remarkable compound that positions us to address some largely unattended, yet immense markets, including diabetes, NASH, and the swath of maladies where pulmonary edema is a problem, starting with infections with the potential to explore cardiovascular diseases in the future. We are thrilled to have a partner in Dr. Andrew Reaume and his team at the Melior family of companies and look forward to shepherding all their exciting work to the next stage of development.”
Metacrine Inc (NASDAQ:MTCR) is a clinical-stage biopharmaceutical company that engages in the discovery and development of therapies for patients with liver and gastrointestinal (GI) diseases, including NASH treatment solutions.
The company offers farnesoid X receptor (FXR), which is central to modulating liver and GI diseases and is now in trials for NASH.
Metacrine Inc (NASDAQ:MTCR) just yesterday reported interim results from a Phase 2a clinical trial evaluating the efficacy and safety of MET642, a farnesoid X receptor (FXR) agonist, in approximately 60 non-alcoholic steatohepatitis (NASH) patients after 16 weeks of treatment. According to the release, MET642 lowered liver fat content, with mean relative reductions of 26.9±27.8 percent in the 3 mg cohort and 9.3±55.8 percent in the 6 mg cohort, compared with 7.5±21.0 percent in the placebo arm.
“We are encouraged by the MET642 interim clinical trial results, as this product candidate demonstrated meaningful liver fat reduction at 3 mg and a potentially class-leading tolerability profile for the treatment of NASH at both 3 mg and 6 mg,” said Preston Klassen, M.D., MHS, CEO, Metacrine. “In this small interim analysis, the 6 mg cohort displayed a non-normal distribution in liver fat changes, as evidenced by differences between the mean and median results. Further clarification of the impact on liver fat at the 6 mg dose will require examination of the complete trial data set, which is anticipated in the first half of 2022. NASH is a complex and chronic disease that we believe will likely require combination regimes to most effectively treat patients. MET642 can potentially serve as an important part of these novel combination approaches.”
If you’re long this stock, then you’re liking how the stock has responded to the announcement. MTCR shares have been moving higher over the past week overall, pushing about 8% to the upside on above average trading volume. Shares of the stock have powered higher over the past month, rallying roughly 25% in that time on strong overall action.
Metacrine Inc (NASDAQ:MTCR) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($74.8M against $7.5M) providing a strong financial foundation for its pipeline development phase.
Other key players in the NASH space include Viking Therapeutics Inc (NASDAQ:VKTX), Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR), Galectin Therapeutics Inc. (NASDAQ:GALT), Intercept Pharmaceuticals Inc (NASDAQ:ICPT), and Gilead Sciences, Inc. (NASDAQ:GILD).
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