DURECT Corp. (DRRX:NASDAQ) announced in a news release positive data from its completed Phase 2a clinical trial of DUR-928 in patients with alcoholic hepatitis (AH).
"We are excited that the first trial of DUR-928 in AH patients demonstrated superior outcomes compared to historical control data," DURECT President and CEO James E. Brown said in the release.
The results show that all 19 patients treated with DUR-928 had "statistically significantly greater reductions from baseline in bilirubin (days 7 and 28) and model for end stage liver disease (MELD) (day 28), as well as statistically significantly lower Lille scores, compared with a historical control group (n=15) from a University of Louisville AH study," the release noted. Of the 19 total enrollees, 12 had severe AH and the remaining 7 had moderate AH.
The lower a patient's Lille score is, the better their prognosis. Generally, a Lille score below 0.45 represents an 85% six-month survival rate. A Lille score above 0.45 tends to be associated with a 25% six-month survival rate.
In DURECT's study, the median Lille score for the 18 AH patients treated with DUR-928 who returned for their Day 7 visit was 0.10; 89%, or 16 out or 18, had a Lille score under 0.45. In comparison, 53%, or 8 out of 15, patients in the University of Louisville study had a Lille score below 0.45. Those patients were treated with either supportive care or supportive care plus corticosteroids, and their median Lille score was 0.41.
As for safety in DURECT's study, all patient tolerated DUR-928, and none reported any associated adverse events at all dose levels tested.
Going forward, DURECT will continue its analysis of the clinical data and report on it at the upcoming annual meeting of the American Association for the Study of Liver Diseases later this year, in November. The biopharma also intends to meet with the U.S. Food and Drug Administration to discuss the design of its next DUR-928 AH clinical trial and the regulatory path to approval.
Read what other experts are saying about:
Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: DURECT Corp. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
