TICKERS: DRRX

Trial Results Set Up DURECT Corp. for 'Exciting Year'

Source:

Positive results in a Phase 1b trial of DURECT Corp.'s candidate for the treatment of nonalcoholic steatohepatitis (NASH), which were presented at the 2017 International Liver Congress, prompted comments from a pair of analysts.

Source: WikiCommons

In an April 23 conference update, analyst David Sherman of LifeSci Capital commented on the results of DURECT Corp.'s (DRRX:NASDAQ) Phase 1b study of DUR-928, noting the compound "was well tolerated overall," that the data support ongoing evaluation of the therapy, and that "investigators speculated on the plausibility of a therapeutic effect due to biomarker reductions at approximately 12 hours following dosing."

In an April 25 Laidlaw & Company research report, analyst Francois Brisebois observed that at its lowest dose, DUR-928 "showed reduction in liver function and injury biomarkers after only 12 hours. Additionally, inflammation markers and mediators such as high sensitivity C-reactive protein (hsCRP) and IL-18, as well as CK18 (cell death biomarker), were reduced in NASH (especially in cirrhotics). The full data set confirmed these findings with a single dose, which is a real positive in our opinion."

The Laidlaw analyst also noted that with the Phase 3 PERSIST trial "of Posimir for post-operative pain expected to read-out by year end-2017, IND [investigational new drug] filings in both liver and kidney programs around mid-2017 and initiation of a Phase 2 trial for DUR-928 in mid-2017 for primary sclerosing cholangitis (PSC), 2017 should be an exciting year for DRRX."

According to a report by Reuters, the market for NASH, also known as nonalcoholic fatty liver disease, "is forecast to be $20 billion to $35 billion as populations with fatty diets increasingly fall victim to a condition with no approved treatments."

Large pharmas including Pfizer Inc. (PFE:NYSE) and Bristol-Myers Squibb Co. (BMY:NYSE) are looking for candidates for development and marketing, according to the Reuters article, which quotes Morris Birnbaum, chief scientific officer for internal medicine for Pfizer, as saying the company is "actively looking on the outside for opportunities . . .to complement our internal program."

The Reuters article also quoted Len Yaffe of StockDoc Partners, who noted the DURECT drug "looks incredibly promising as it relates to inflammation and fibrosis." Yaffe told the news agency that "investors with tolerance for risk could do well to buy shares in several small-cap and micro-cap companies with promising NASH drugs in early development . . .the payoff could be considerable."

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