This Biotech Has the Upper Hand Over Allergan and Gilead in the Heated Nash Battle

September 23, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Allergan 's recent acquisitions of the Bay Area’s Tobira and San Diego-based Akarna Therapeutics has turned the spotlight on non-alcoholic steatohepatitis (NASH) and other liver diseases.

For some time, Gilead Sciences was the leader in the liver-disease market, largely based on its dominance with hepatitis C (HCV). Now it appears that Gilead is taking second fiddle to Intercept Pharmaceuticals , while Allergan is positioning itself as a major player.

NASH is sometimes called the “silent” liver disease. It resembles alcoholic liver disease, but appears in people who drink little or no alcohol. However, it can be severe and lead to cirrhosis. According to the National Institute of Diabetes and Digestive and Kidney Diseases, NASH affects 2 to 5 percent of people in the U.S. There are currently no specific treatments aside from weight loss, increased physical activity, and avoiding alcohol and unnecessary medications.

Alethia Young, an analyst with Credit Suisse, in a recent note for clients, pointed out that Intercept and others are focused on targeting farnesoid X receptors (FXR), proteins found in the liver and intestines. They can be manipulated to regulate carbohydrate and lipid metabolism, bile-acid homeostasis and fibrosis, which are all linked to NASH.

A few other companies are focused on using non-bile FXRs. But, Young wrote, Intercept’s Phase II FLINT trial is the “most mature data set in the space to show significance on both fibrosis and liver histology based on pre-specified parameters.”

Since there are no current treatments and the U.S. market is probably 6 to 15 million people, there is probably room for more than one company or product, but Young notes that Intercept’s drug seems to have a 75 percent success rate compared to Gilead’s 50 percent success rate in early trials. But other players in the market include Novartis . Enanta, and thanks to two acquisitions in one day, Allergan .

Several of the companies involved are evaluating their drugs in combination treatments. Allison Gatlin, writing for Investor’s Business Daily, said, “Tobira’s CVC successfully reduced fibrosis without worsening NASH in 20 percent of patients vs. 10 percent treated with a placebo. Intercept’s Phase II trial for OCAs (obeticholic acid) improved fibrosis in 35 percent of patients versus 19 percent who received the placebo.”

But Allergan apparently plans to combine Tobira’s CVC with Akarna’s non-bile acid FXR. “We think a combination of regimens will be an important part of the treatment paradigm and we think Intercept is positioned well here long term,” Young wrote.

Akarna’s lead product is AKN-083, a non-bile acid FXR agonist.

Gilead acquired Nimbus Apollos earlier this year for its Acetyl-CoA Carboxylase (ACC) inhibitor program, which grew its NASH program. Gilead is also investigating its simtuzumab for NASH.

Seeking Alpha wrote, “In shelling out $50 million for Akarna Allergan looks to have sent another, albeit early, signal that the likes of Intercept, Gilead and Novartis have to contend with a bigger competitor. To underline the point, Allergan’s chief executive, Brent Saunders, said in a call today that his company was ‘putting down a big marker in NASH.’”