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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1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own shares of the following companies mentioned in this article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from LifeSci Capital, EASL 2017 Conference Update, April 23, 2017
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This research contains the views, opinions and recommendations of LifeSci Capital, LLC (“LSC”) research analysts.
LSC expects to receive or intends to seek compensation for investment banking services from one or more companies that are the subject of this report in the next three months. Additionally, an affiliate of LSC has received compensation from CymaBay, Durect, and Galmed for providing non-investment banking securities-related services, non-securities services, and other products or services other than investment banking services within the past twelve months. LSC does not make a market in the securities of any of the companies that are the subject of this report.
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Disclosures from Laidlaw & Company, Durect Corporation, Equity Research Company Report, April 25, 2017
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