DUR-928 for psoriasis enters phase 2a proof-of-concept trial

[Fred]

Another new treatment for psoriasis is in the pipeline.

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DURECT Corporation today announced it has commenced patient dosing in a Phase 2a proof-of-concept trial with topical DUR-928 in patients with mild to moderate plaque psoriasis.  DUR-928, the lead investigational product in the Company's Epigenetic Regulator Program, is an endogenous, first-in-class small molecule, which may have broad applicability in chronic hepatic diseases such as nonalcoholic steatohepatitis (NASH), acute organ injuries such as alcoholic hepatitis (AH) and acute kidney injury (AKI), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.

"As topical agents continue to be the mainstay of treatment for patients suffering from mild to moderate plaque psoriasis, especially localized plaque psoriasis, it is important to investigate a topical agent with a novel mechanism of action," stated Dr. Howard Maibach, Professor of Dermatology at the University of California San Francisco.  "Should the results be positive, DUR-928 should be studied in additional inflammatory skin diseases."

"Commencing patient dosing in this proof-of-concept psoriasis trial is an important milestone in line with our focus for DUR-928 in 2019, which is to produce data with the potential to create significant commercial and partnering value," said James E. Brown, President and CEO of DURECT.

In this Phase 2a, randomized, double-blind, vehicle-controlled proof-of-concept clinical trial, DUR-928 will be applied topically once-daily for four weeks in patients with mild to moderate plaque psoriasis. The trial is being conducted at multiple clinical sites in the U.S.  Twenty patients are planned to be enrolled to obtain approximately 15 evaluable patients. Patients will serve as their own controls, applying DUR-928 to the plaque on one arm and the vehicle to a similar plaque on the other arm. After the treatment period, patients will be followed for an additional four weeks. The primary efficacy endpoint will be change in local psoriasis scores from baseline in the DUR-928-treated plaques compared to that in the vehicle-treated plaques. We expect to announce top line data from this study in the second half of 2019.

DURECT previously conducted an exploratory Phase 1b trial in psoriasis patients (9 evaluable patients) in Australia.  The trial was randomized, double-blinded, placebo and self-controlled, using a micro-plaque assay with intralesional injections of DUR-928.  The results were encouraging and warranted advancing into the current proof-of-concept trial with topically applied DUR-928.

Source: durect.com

[Bill]

Thank you Fred. Early days but it looks interesting. I like the idea of its potential for both topical and systemic use.

Cheers

[guttums]

I see it is a topical formula like a patch applied for 2 hrs. They say it reduced IL-17 a biomarker for plaque psoriasis. It also protect the hepatocellular damage. Hope it is safe enough so that other strong meds can be avoided. Has any one so far has any experience with this drug?

[Caroline]

I see it is a topical formula like a patch applied for 2 hrs. They say it reduced IL-17 a biomarker for plaque psoriasis. It also protect the hepatocellular damage. Hope it is safe enough so that other strong meds can be avoided. Has any one so far has any experience with this drug?

No experience yet, but a remark. IL-17 is mainly a bio marker for Psoriatic Arthritis. It is certainly true that reducing it can have a positive effect on Psoriasis. The results of cosentyx show that several people gain with the blocking of IL-17.

Welcome to psoriasisclub by the way..

Caroline

[guttums]

But the biological agents has many side effects including systemic. This one looks like a big winner if it really works . Because, a) it avoids steroid exposure.
b). It has NO side effects. c) It is good for plaque psoriasis which is not very generalised. I hope someone who tried the DUR 928 has something to say.