{"id":57070,"date":"2024-07-09T12:04:11","date_gmt":"2024-07-09T12:04:11","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/07\/09\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/"},"modified":"2024-07-09T12:04:11","modified_gmt":"2024-07-09T12:04:11","slug":"kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/","title":{"rendered":"Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sj\u00f6gren\u2019s Disease"},"content":{"rendered":"
\n

\u2013 Abiprubart Phase 2b clinical trial in Sj\u00f6gren\u2019s Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations\u00a0\u2013<\/em><\/p>\n

\u2013 Abiprubart clinical development in Sj\u00f6gren\u2019s Disease fully funded; company expects to remain cash flow positive on an annual basis\u00a0\u2013<\/em><\/p>\n

LONDON, July 09, 2024 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals International, plc<\/a> (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 Sj\u00f6gren\u2019s Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.<\/p>\n

\u201cSj\u00f6gren\u2019s Disease is a debilitating, chronic autoimmune disorder currently with no FDA-approved therapies. Commencing the next phase of development of abiprubart in Sj\u00f6gren\u2019s Disease is an important step forward for patients,\u201d said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. \u201cThis 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 Sj\u00f6gren\u2019s Disease, and the company expects to remain cash flow positive on an annual basis.\u201d<\/p>\n

Phase 2b Clinical Trial of Abiprubart in Sj\u00f6gren\u2019s Disease<\/u><\/strong>
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 Sj\u00f6gren\u2019s Disease.<\/p>\n

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\u00a0Sj\u00f6gren\u2019s\u00a0Syndrome 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.<\/p>\n

About Kiniksa<\/strong>
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\u2019s immune-modulating assets, ARCALYST\u00ae<\/sup>, 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\u00a0www.kiniksa.com<\/a>.<\/p>\n

About Abiprubart <\/strong>
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.<\/p>\n

Forward-Looking Statements<\/strong>
This press release contains forward-looking statements. In some cases, you can identify forward- looking statements by terms such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cplan,\u201d \u201canticipate,\u201d \u201ccould,\u201d \u201cintend,\u201d \u201ctarget,\u201d \u201cproject,\u201d \u201ccontemplate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cpredict,\u201d \u201cpotential\u201d or \u201ccontinue\u201d 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.<\/p>\n

These forward-looking statements are based on management\u2019s 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.<\/p>\n

These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption \u201cRisk Factors\u201d 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\u2019s 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.<\/p>\n

Every Second Counts!<\/em><\/strong> \u00ae<\/em><\/strong><\/sup><\/p>\n

Kiniksa Investor and Media Contact<\/strong>
Rachel Frank
(339) 970-9437
rfrank@kiniksa.com<\/a><\/p>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

\u2013 Abiprubart Phase 2b clinical trial in Sj\u00f6gren\u2019s Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations\u00a0\u2013 \u2013 Abiprubart clinical development in Sj\u00f6gren\u2019s Disease fully funded; company expects to remain cash flow positive on an annual basis\u00a0\u2013 LONDON, July 09, 2024 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage […]\n","protected":false},"author":1,"featured_media":57071,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-57070","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"\nKiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sj\u00f6gren\u2019s Disease - Biz and Live in Saigon<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sj\u00f6gren\u2019s Disease\" \/>\n<meta property=\"og:description\" content=\"\u2013 Abiprubart Phase 2b clinical trial in Sj\u00f6gren\u2019s Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations\" \/>\n<meta property=\"og:url\" content=\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Biz and Live in Saigon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SaigonbizGroup\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-09T12:04:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/english.saigonbiz.com\/vn\/wp-content\/uploads\/2024\/07\/Kiniksa-Pharmaceuticals-Ltd-.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1\" \/>\n\t<meta property=\"og:image:height\" content=\"1\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#\/schema\/person\/267b348e6cf32a66aab33637c2d399a6\"},\"headline\":\"Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sj\u00f6gren\u2019s Disease\",\"datePublished\":\"2024-07-09T12:04:11+00:00\",\"dateModified\":\"2024-07-09T12:04:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/\"},\"wordCount\":915,\"publisher\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#organization\"},\"articleSection\":[\"Pr Newswire\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/\",\"url\":\"https:\/\/english.saigonbiz.com\/vn\/kiniksa-pharmaceuticals-commences-enrollment-in-abiprubart-phase-2b-clinical-trial-in-sjogrens-disease\/\",\"name\":\"Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sj\u00f6gren\u2019s Disease - 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