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Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sjögren’s Disease

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Kiniksa Pharmaceuticals has begun enrolling patients in a Phase 2b clinical trial for abiprubart, a humanized anti-CD40 monoclonal antibody, aimed at treating Sjögren’s Disease, a debilitating autoimmune disorder. The trial will assess the efficacy of abiprubart administered biweekly and monthly via subcutaneous injections over a 24-week period, involving around 201 participants. The primary measure of success is the change in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) compared to a placebo. The study will also include a long-term extension phase where all participants receive active treatment. Importantly, Kiniksa expects to remain cash flow positive during this development.

Positive
  • Commenced enrollment for Phase 2b trial of abiprubart in Sjögren’s Disease.
  • Trial aims to assess biweekly and monthly subcutaneous administration efficacy.
  • Approximately 201 patients will be randomized in a 1:1:1 ratio for the 24-week trial.
  • Expected cash flow positive status throughout the clinical development phase.
Negative
  • No FDA-approved therapies currently exist for Sjögren’s Disease, indicating high unmet need and potential risk if the trial is unsuccessful.

The initiation of a Phase 2b clinical trial for abiprubart in treating Sjögren’s Disease is a significant milestone for Kiniksa Pharmaceuticals. Sjögren’s Disease is a chronic autoimmune disorder that impacts moisture-producing glands, leading to symptoms including dry eyes and mouth, fatigue and joint pain. With no current FDA-approved treatments, there's a substantial unmet need, making this trial important for both patients and the company.

Abiprubart, designed to inhibit the CD40-CD154 interaction, targets a pathway integral to immune system modulation. The success of this trial not only has the potential to address this unmet need but also to validate the mechanism of action for other autoimmune diseases. The use of subcutaneous administration offers a practical and patient-friendly approach, enhancing adherence and potentially improving outcomes.

The trial's design, with a placebo-controlled, double-blind format, helps ensure robust data integrity and reliability. Monitoring the change from baseline in ESSDAI, a standardized measure of disease activity, provides a clear metric for evaluating efficacy. Given the chronic nature of Sjögren’s, the 24-week primary endpoint followed by a long-term extension will offer valuable insights into both short-term efficacy and long-term safety.

Kiniksa’s announcement that the clinical development of abiprubart is fully funded and that the company expects to remain cash flow positive annually is noteworthy. Maintaining a positive cash flow while funding clinical trials is often challenging for biopharmaceutical companies. This not only suggests strong financial health but also proper resource management.

Investors should consider the potential market size for a successful Sjögren’s Disease treatment. With no approved therapies, Kiniksa could capture significant market share if abiprubart proves effective. However, clinical trials are inherently risky and success is not guaranteed.

From a financial perspective, the company’s ability to sustain operations without additional external funding reduces dilution risk for current shareholders. Additionally, the potential differentiation of abiprubart through convenient subcutaneous administration could offer a competitive edge in patient preference, possibly translating to higher market penetration and revenue once approved.

– Abiprubart Phase 2b clinical trial in Sjögren’s Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations –

– Abiprubart clinical development in Sjögren’s Disease fully funded; company expects to remain cash flow positive on an annual basis –

LONDON, July 09, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced that it has commenced enrollment of the Phase 2b clinical trial of abiprubart in Sjögren’s Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.

“Sjögren’s Disease is a debilitating, chronic autoimmune disorder currently with no FDA-approved therapies. Commencing the next phase of development of abiprubart in Sjögren’s Disease is an important step forward for patients,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “This Phase 2b clinical trial builds on external mechanistic proof-of-concept as well as learnings from our own prior clinical data. Additionally, we believe abiprubart has the potential for differentiation in addressing unmet need through convenient subcutaneous administration. Importantly, our current operating plan includes clinical development of abiprubart in Sjögren’s Disease, and the company expects to remain cash flow positive on an annual basis.”

Phase 2b Clinical Trial of Abiprubart in Sjögren’s Disease
The randomized, double-blind, placebo-controlled Phase 2b clinical trial is designed to evaluate the treatment response of chronic subcutaneous (SC) administration of abiprubart in patients with Sjögren’s Disease.

The placebo-controlled portion of the trial will randomize approximately 201 patients in a 1:1:1 ratio to receive abiprubart 400 mg SC biweekly, 400 mg SC monthly, or placebo over a period of 24 weeks. The primary endpoint is change from baseline in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) versus placebo at Week 24. Subsequently, patients will enter a long-term extension in which active treatment will be given in all study arms for an additional 24 weeks.

About Kiniksa
Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST®, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information, please visit www.kiniksa.com.

About Abiprubart
Abiprubart is an investigational humanized monoclonal antibody that binds to CD40 and is designed to inhibit the CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 co-stimulatory interaction is an attractive approach to addressing multiple autoimmune disease pathologies.

Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify forward- looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding our belief that abiprubart has the potential for differentiation in addressing unmet need through convenient subcutaneous administration; our expectation to remain cash flow positive on an annual basis; and our belief that all of our other product candidates offer the potential for differentiation.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; and changes in our operating plan, business development strategy or funding requirements.

These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Every Second Counts! ®

Kiniksa Investor and Media Contact
Rachel Frank
(339) 970-9437
rfrank@kiniksa.com


FAQ

What is the purpose of Kiniksa Pharmaceuticals' Phase 2b clinical trial for abiprubart?

The Phase 2b clinical trial aims to evaluate the treatment response of abiprubart in patients with Sjögren’s Disease through biweekly and monthly subcutaneous administrations.

When did Kiniksa Pharmaceuticals commence enrollment for the abiprubart trial?

Kiniksa Pharmaceuticals announced the commencement of enrollment for the abiprubart Phase 2b clinical trial on July 09, 2024.

What is the primary endpoint of the abiprubart Phase 2b trial in Sjögren’s Disease?

The primary endpoint is the change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) versus placebo at Week 24.

How many patients will be enrolled in the abiprubart Phase 2b clinical trial?

Approximately 201 patients will be enrolled and randomized in a 1:1:1 ratio to receive biweekly, monthly subcutaneous doses of abiprubart, or a placebo.

What is the anticipated financial impact on Kiniksa Pharmaceuticals during the abiprubart clinical development?

Kiniksa Pharmaceuticals expects to remain cash flow positive on an annual basis during the clinical development of abiprubart for Sjögren’s Disease.

Kiniksa Pharmaceuticals, Ltd.

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