Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe

News Update


Biopharma to Accelerate Trial Timeline with Amendment
News Update

Share on Stocktwits


The change relates to the onset of dosing for patients with different degrees of disease.

DURECT Corp. (DRRX:NASDAQ) announced in a news release it revised its ongoing Phase 2a dose escalation trial of DUR-928 for alcoholic hepatitis (AH), which encompasses two populations: patients with moderate disease (Part A) and patients with severe disease (Part B). The amendment allows DURECT to move up the start of dosing of patients with severe AH.

Now, Part B patients can be enrolled for the first, or lowest, dose (30 mg) at the same time enrollment continues for Part A patients to get the next highest dose (90 mg). (Part A patients, four of them, already received the 30 mg dose.) Three dose levels of DUR-928 (30, 90 and 150 mg), intravenously administered, are planned for testing in Part A patients, and each dose group will contain four to six patients.

"We expect [the parallel dosing] to accelerate the overall timeline for the trial," President/CEO James Brown said in the release. "Over the course of the trial, the clinical sites have encountered many severe AH patients who may have qualified for Part B but were deemed screen failures due to their model for end-stage liver disease scores being too high to participate in Part A."

The study aims to evaluate safety, pharmacokinetic and pharmacodynamic signals and the effect of DUR-928 on liver biochemistry and biomarkers, according to the company.


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.

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe