Adial Pharmaceuticals Appoints David Rubenstein, M.D., Ph.D., as Chief Scientist to Advance its Colon-Targeted AhR Agonist, AT177, for Ulcerative Colitis

Planned preclinical studies will characterize AT177's mechanism and colon selectivity relative to other agents in development for ulcerative colitis.

Rhea-AI Summary

Adial Pharmaceuticals (Nasdaq: ADIL) appointed David Rubenstein, M.D., Ph.D., as Chief Scientist to lead its research and scientific strategy.

His responsibilities include advancing AT177, an oral, colon-targeted aryl hydrocarbon receptor (AhR) agonist being developed for ulcerative colitis. AhR is the biological receptor the drug targets. Adial expects first-in-human trials in 2027, following studies needed to support an application to begin human testing. Rubenstein will oversee discovery, translational and nonclinical research. As Dermavant's Chief Scientific Officer, he led the AhR agonist tapinarof through development, FDA approval and commercialization.

Positive

• Minor point. Forward-looking: it has not happened yet and may not happen.AT177 development plans include first-in-human trials expected in 2027, following studies supporting an application to begin human testing.

Negative

• None.

Key Figures

First-in-human trial timing: 2027

First-in-human trial timing

2027

Trials expected following IND-enabling studies

Historical Context

2 past events · Latest: Aug 17

2 events

1. Aug 17

   AT177 pipeline update

   24h Move

   +24.9%

   Reported AT177 in IND-enabling studies, with a first-in-human trial planned for 2027.

2. Jun 11

   Azora acquisition

   24h Move

   +38.0%

   Acquisition added AT177, the ulcerative-colitis candidate, to Adial's pipeline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

aryl hydrocarbon receptor, ind-enabling, first-in-human, ulcerative colitis

4 terms

aryl hydrocarbon receptor medical

"a proprietary, oral, colon-targeted aryl hydrocarbon receptor (AhR) agonist"

Aryl hydrocarbon receptor (AHR) is a protein inside cells that detects certain environmental chemicals and helps turn genes on or off in response, like a smoke alarm that triggers specific reactions. It matters to investors because AHR influences how the body handles toxins and can be a target or safety concern in drug development, environmental liability assessment, and biomarker-driven regulatory decisions that affect company value.

ind-enabling regulatory

"including the continued development of AT177"

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.

first-in-human technical

"toward first-in-human trials expected in 2027"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

ulcerative colitis medical

"being developed for the treatment of ulcerative colitis (UC)"

A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Former Dermavant Chief Scientific Officer led development of tapinarof, the first FDA-approved AhR agonist, from mechanistic understanding through approval and commercialization

Will lead AT177 through IND-enabling studies toward first-in-human trials expected in 2027

GLEN ALLEN, Va., Oct. 16, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (Nasdaq: ADIL) ("Adial" or the "Company"), which recently acquired Azora Therapeutics, today announced the appointment of David Rubenstein, M.D., Ph.D. as Chief Scientist. Dr. Rubenstein will lead the Company's research and scientific strategy, including the continued development of AT177, a proprietary, oral, colon-targeted aryl hydrocarbon receptor (AhR) agonist being developed for the treatment of ulcerative colitis (UC).

Dr. Rubenstein brings deep, directly relevant experience in AhR biology. As Chief Scientific Officer of Dermavant Sciences, he shepherded tapinarof (VTAMA^® cream 1%), the first and only AhR agonist approved by the U.S. Food and Drug Administration, through development, approval and commercialization, for plaque psoriasis and atopic dermatitis. His work established AhR agonism as a clinically validated and commercially proven mechanism in immune-mediated inflammatory disease.

"Dave is one of very few drug developers who has taken an AhR agonist all the way from the lab to patients, and that experience maps directly to what we are building with AT177," said Matt Davidson, Ph.D., Chief Development Officer and Director of Adial. "We believe that his understanding of AhR pharmacology, translational science and the regulatory path for a first-in-class mechanism will be invaluable as we complete IND-enabling work and prepare to enter the clinic next year."

Dr. Rubenstein added, "Tapinarof demonstrated what targeted AhR activation can do for patients with inflammatory disease. The goal now is to bring that biology to the colon while keeping systemic exposure low, which is exactly how AT177 is being designed. I'm excited to join Matt and the team at this stage and to help advance a new oral approach for people with ulcerative colitis who still lack durable treatment options."

As Chief Scientist, Dr. Rubenstein will oversee discovery, translational, and nonclinical research, including the IND-enabling program for AT177 and preclinical studies characterizing AT177's mechanism and colon selectivity relative to other agents in development for UC. Dr. Rubenstein is a physician-scientist and has previously held senior roles focused on preclinical development at Stiefel and GSK. Dr. Rubenstein received his M.D. and Ph.D. from Duke University.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a biopharmaceutical company focused on the development of treatments for serious inflammatory diseases. Following its June 2026 acquisition of Azora Therapeutics, Adial's lead program is AT177, a proprietary, oral, colon-targeted AhR agonist being designed to enable localized activation with limited systemic exposure, in development for the treatment of ulcerative colitis. AT177 is in IND-enabling studies, with clinical trials planned for 2027. Additional information is available at www.Adial.com.

About AT177

AT177 is a fully synthetic, patented, oral AhR agonist being designed to restore mucosal immune homeostasis at the site of disease with minimal systemic exposure. Its active ingredient is a prodrug of indirubin, believed to be one of the most potent AhR agonists in indigo naturalis, a non-FDA-approved botanical extract that has exhibited strong clinical activity and remission rates in ulcerative colitis. In preclinical studies, AT177 demonstrated robust local colonic AhR activation with limited systemic exposure.

Cautionary Note Regarding Forward-Looking Statements

This communication contains "forward-looking statements" within the meaning of the U.S. federal securities laws, including statements regarding the expected contributions of Dr. Rubenstein; the development, design and potential benefits of AT177; the opportunity to bring targeted AhR activation biology to the colon while keeping systemic exposure low; the timing of IND-enabling studies, the planned IND and a Phase 1a clinical trial planned for 2027; and words such as "believes," "expects," "anticipates," "intends," "plans," "will," "may" and similar expressions identify forward-looking statements. These statements involve risks and uncertainties, including the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company's ability to obtain the capital necessary to fund its research and development; the Company’s ability to complete preclinical and clinical studies on time and with desired results; the FDA allowing the Company's planned IND to proceed; acceptance of the Company’s product candidates in the marketplace and the successful development, marketing or sale of its products; the Company’s ability to obtain stockholder approval of the conversion of its Series A preferred stock, without which it could be required to make significant cash payments to holders of that stock; Nasdaq’s approval of the Company’s initial listing application; the continued maintenance and growth of the Company’s patent estate and its ability to retain its key employees or maintain the Company’s Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the cautionary statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Media Contact:

Ashley Biladeau
Inizio Evoke Comms
Ashley.Biladeau@inizioevoke.com

Investor Contact:

Mike Moyer, Managing Director, LifeSci Advisors, LLC
Phone: (617) 308-4306
Email: mmoyer@lifesciadvisors.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Adial expect AT177 to enter human trials?

Adial expects first-in-human trials in 2027. Rubenstein will lead AT177 through the studies needed to support an application to begin human testing.