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Biopharma Expects Data Readouts in Psoriasis, NASH in H2/19
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Two recently launched clinical trials, and related conference calls, were reviewed in an H.C. Wainwright & Co. report.

In an April 1 research note, analyst Ed Arce reported that DURECT Corp. (DRRX:NASDAQ) just hosted a conference call and webcast featuring a key opinion leader on psoriasis and has a similar call scheduled for nonalcoholic steatohepatitis (NASH), both in connection with clinical programs for its lead product candidate, DUR-928.

In the webcast held on March 29, Dr. Howard Maibach described the challenges clinicians face when it comes to treating plaque psoriasis and noted that due to a lack of effective remedies, the condition remains largely under-addressed, Arce related. Dr. Maibach, a professor at the University of California, San Francisco's Department of Dermatology and founder of its Psoriasis Clinic, said more than 50% of psoriasis patients are unhappy with their current treatments, primarily topical steroids, which are not curative.

Also during the call, company representatives discussed DURECT's development plan for DUR-928 in plaque psoriasis, Arce indicated. Earlier in March, in three U.S. clinical sites, dosing began in a randomized, double-blind, Phase 2a proof-of-concept trial evaluating topical DUR-928 in 20 patients with mild to moderate plaque psoriasis. For 28 days, patients will treat the plaque on one arm with DUR-928, and comparable plaque on the other arm with a vehicle agent.

Topline results are due in H2/19. "We believe positive data in this study could lead to a collaboration deal with a larger partner leveraged to the dermatology space," wrote Arce.

The analyst noted that on March 27, DURECT initiated a second DUR-928 study, this one in patients with NASH. It is an open-label, 28-day, Phase 1b trial with 20 participants enrolled in three dose groups, low, middle and high.

Results from the NASH study also are expected in H2/19. "If this trial is successful, DURECT could proceed to an early Phase 2 imaging-based NASH study," Arce commented. "If so, we believe NASH could quickly become the key value driver for DRRX shares."

DURECT will host a key opinion leader conference call and webcast about NASH, Arce relayed. It is scheduled to immediately follow the annual EASL meeting, at 11 a.m. EST on Wednesday, April 17. During the event, Dr. Brent Tetri, professor of Internal Medicine at Saint Louis University, will discuss NASH, and DURECT will summarize its DUR-928 development program for the indication.

H.C. Wainwright has a Buy rating and a $3 per share target price on DURECT, whose stock is currently trading at around $0.63 per share.


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.
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Disclosures from H.C. Wainwright & Co., DURECT Corporation, First Take, April 1, 2019

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce and Thomas Yip, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of DURECT Corporation (including, without limitation, any option, right, warrant, future, long or short position).

As of February 28, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DURECT Corporation.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm does not make a market in DURECT Corporation as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

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