Conduit Pharmaceuticals Provides Research and Development Update on Progress for Pipeline Assets AZD1656, AZD5658, and AZD5904

Rhea-AI Summary

Conduit Pharmaceuticals (Nasdaq: CDT) has announced significant progress in its R&D pipeline development for three key assets: AZD1656, AZD5658, and AZD5904. The company has partnered with Charles River Laboratories for preclinical studies of glucokinase inhibitors in autoimmune diseases, focusing on lupus, with results expected in Q2 2025.

The company is designing a Phase II clinical trial for AZD1656, targeting systemic lupus erythematosus (SLE) with nephritis and ANCA-associated vasculitis (AAV). The trial will be single-center, double-blind, and placebo-controlled.

Notable developments include:

• Granted composition-of-matter patents for AZD1656 Cocrystals by Japan Patent Office and IP Australia
• Pending patent applications at USPTO and European Patent Office
• Partnership with Agility Life Sciences for developing novel solid oral-dosage forms
• Ongoing formulation optimization at Cambridge Science Park facility

Positive

• Expansion of patent protection with granted patents in Japan and Australia
• Strategic partnership with Charles River Laboratories for preclinical studies
• Development of new proprietary drug formulations through Agility Life Sciences collaboration
• Advancement of Phase II clinical trial design for multiple autoimmune indications

Negative

• Phase II trial still in design phase without confirmed start date
• Patent applications still pending in major markets (US and Europe)

Insights

Biotech Research Analyst

Conduit Pharmaceuticals has reported meaningful progress across multiple fronts for its AstraZeneca-licensed assets, demonstrating forward momentum in both preclinical and clinical development pathways.

The partnership with Charles River Laboratories to evaluate glucokinase inhibitors in lupus models represents a strategic expansion into the autoimmune space. Unlike traditional immunosuppressants, glucokinase inhibitors may offer a novel immunomodulatory approach through Treg regulation. With results expected in Q2 2025, this preclinical work establishes a critical foundation for subsequent clinical development while potentially de-risking future trials.

The advancement of AZD1656 toward a Phase II trial in systemic lupus erythematosus with nephritis and ANCA-associated vasculitis is particularly noteworthy. These indications represent areas of significant unmet need with historically challenging development pathways. The double-blind, placebo-controlled design should provide robust mechanistic validation, though the company will face the typical enrollment challenges associated with these relatively rare conditions.

From an intellectual property standpoint, the granted composition-of-matter patents for AZD1656 cocrystals in Japan and Australia, with pending applications in the US and Europe, significantly strengthen Conduit's commercial positioning. These IP developments align with the company's stated strategy of out-licensing and commercialization.

The formulation development work through Agility Life Sciences demonstrates a patient-centric approach to drug delivery, potentially creating additional barriers to future competition while improving therapeutic utility. Such differentiation will be important in the competitive autoimmune space.

While these developments signal positive momentum, investors should recognize that even the most advanced assets remain in early-stage development, requiring substantial investment before commercialization. The multiple anticipated milestones in 2025 represent potential value-creating catalysts that could position Conduit for partnership opportunities or increased valuation, assuming positive outcomes.

• Conduit Pharmaceuticals advances its pipeline with key progress in preclinical lupus studies for AZD5658, Phase IIa trial design for AZD1656, formulation optimization, and IP expansion, positioning the Company for near-term milestones and growth.

NAPLES, Fla. and CAMBRIDGE, United Kingdom, March 19, 2025 (GLOBE NEWSWIRE) -- Conduit Pharmaceuticals Inc. (Nasdaq: CDT) (“Conduit Pharmaceuticals” or “Conduit” or the “Company”) today provides an R&D update on the development progress of pipeline assets AZD1656, AZD5658, and AZD5904. The Company has made significant progress with respect to confirmatory pre-clinical studies, clinical trial planning, formulation development, and intellectual property (IP) expansion to position its pipeline for continued success. These exciting developments underscore Conduit’s momentum and near-term potential.

Conduit has partnered with Charles River Laboratories Inc. to conduct preclinical studies evaluating its glucokinase inhibitors towards applications in autoimmune diseases, with an initial focus on lupus. The study aims to assess the impact of drug on disease progression in a well-established lupus model, using standard disease progression readouts, while also evaluating its effect on inflammatory markers and pro-inflammatory cytokine levels, with a focus on Treg immunoregulation. This study is expected to generate critical data on the therapeutic potential, informing future clinical development plans with results anticipated in Q2 2025, with a view to potentially increasing the probability of subsequent clinical trial success.

In parallel, Conduit continues to optimize the protocol for the design of its Phase II clinical trial for AZD1656. The trial will focus on two multisystem autoimmune diseases: systemic lupus erythematosus (SLE) with nephritis and ANCA-associated vasculitis (AAV). The current design is a single-center, double-blind, placebo-controlled study, designed to provide robust data on the safety, tolerability, and mechanistic effects of AZD1656. The Company will provide further updates on the finalization of the trial design and contracting for the study.

At its research and development facility at Cambridge Science Park, Conduit is enhancing its IP portfolio and optimize the formulation of its pipeline assets. In the laboratory, the Company is evaluating the assets licensed through the AstraZeneca partnership and other assets of critical interest. Significant progress has also been made in securing intellectual property (IP) protection for Conduit’s lead asset, AZD1656. Recent milestones include the grant of a composition-of-matter patent for the AZD1656 Cocrystals by the Japan Patent Office (JPO) and IP Australia, with pending applications at the USPTO and European Patent Office, and other global patent offices, expected to be approved early in the second quarter. In addition, Conduit is actively working to develop new solid forms of its key assets, including AZD1656, AZD5904 and AZD5658. These approvals and ongoing efforts are expected to strengthen Conduit’s IP portfolio and support its strategy of out-licensing and commercialization.

Through a strategic services agreement with Agility Life Sciences (“Agility”), a formulation development CDMO, Conduit is developing novel solid oral-dosage forms for its pipeline assets. Key activities include the development of proprietary solid forms for all autoimmune pipeline assets, protected by composition-of-matter IP, and collaboration with Agility to design enhanced oral dosage forms tailored to patient preferences and disease-specific needs. The development of proprietary forms of AZD1656, specifically tailored to unmet patient needs, are showing positive progress.

These efforts underscore Conduit’s commitment to advancing its pipeline and delivering innovative treatments for autoimmune disorders. The Company expects key results and critical milestones to be reached in the near term, positioning Conduit for exciting growth and development.

About Conduit Pharmaceuticals

Conduit is a multi-asset clinical stage, life science company delivering an efficient model for compound development. Conduit both acquires and funds the development of Phase 2-ready assets, building an integrated and advanced platform-driven approach powered by artificial intelligence (AI) and cybernetics, and seeking an exit through third-party license deals following successful clinical trials. Led by a highly experienced team of pharmaceutical executives including Dr. David Tapolczay and Dr. Freda Lewis-Hall, this novel approach is a departure from the traditional pharma/biotech business model of taking assets through regulatory approval.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical facts contained in this press release, including statements regarding Conduit's future results of operations and financial position, Conduit's business strategy, prospective product candidates, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, future results of current and anticipated studies and business endeavors with third parties, and future results of current and anticipated product candidates, are forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to; the inability to maintain the listing of Conduit's securities on Nasdaq; the ability to recognize the anticipated benefits of the business combination completed in September 2023, which may be affected by, among other things, competition; the ability of the combined company to grow and manage growth economically and hire and retain key employees; the risks that Conduit's product candidates in development fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable authorities on a timely basis or at all; changes in applicable laws or regulations; the possibility that Conduit may be adversely affected by other economic, business, and/or competitive factors; and other risks and uncertainties to be identified in the proxy statement/prospectus (as amended and supplemented) relating to the business combination completed in September 2023, including those under "Risk Factors" therein, and in other filings made by Conduit with the U.S. Securities and Exchange Commission. Moreover, Conduit operates in a very competitive and rapidly changing environment. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Conduit's control, you should not rely on these forward-looking statements as predictions of future events. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Conduit assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Conduit gives no assurance that it will achieve its expectations.

Investors & Media:
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FAQ

What are the key autoimmune diseases targeted by Conduit Pharmaceuticals (CDT) in their Phase II trial?

The Phase II trial targets systemic lupus erythematosus (SLE) with nephritis and ANCA-associated vasculitis (AAV).

When are the preclinical lupus study results expected for CDT's glucokinase inhibitors?

Results from the preclinical lupus studies are anticipated in Q2 2025.

Which patents has CDT recently secured for AZD1656 Cocrystals?

Composition-of-matter patents have been granted by the Japan Patent Office and IP Australia.

What is the partnership between Conduit Pharmaceuticals (CDT) and Charles River Laboratories focused on?

The partnership focuses on conducting preclinical studies evaluating glucokinase inhibitors for autoimmune diseases, particularly lupus.

How is CDT developing new formulations for its pipeline assets?

CDT is working with Agility Life Sciences to develop novel solid oral-dosage forms and proprietary solid forms for all autoimmune pipeline assets.