{"id":933661,"date":"2026-02-03T08:38:19","date_gmt":"2026-02-03T13:38:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/"},"modified":"2026-02-03T08:38:19","modified_gmt":"2026-02-03T13:38:19","slug":"polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/","title":{"rendered":"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch"},"content":{"rendered":"

\nOral presentation provides additional scientific rationale on Krabbe disease, one of four LSDs in the Phase 2 SOTERIA basket trial designed to evaluate the safety and clinical activity of lead drug candidate PLX-200
\n<\/h2>\n
\n

PARAMUS, NJ, Feb. 03, 2026 (GLOBE NEWSWIRE) — Polaryx Therapeutics (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (\u201cLSDs\u201d), announces it will be presenting a late-breaking abstract on new data for PLX-200, an investigational therapy for the treatment of Krabbe disease (globoid cell leukodystrophy) at the 22nd Annual WORLDSymposium\u2122<\/i>, held February 2-6, 2026 in San Diego, Calif. These data support the continued advancement on progressing the launch of the SOTERIA trial, a Phase 2, open-label, single arm trial intended to assess the safety, tolerability, and clinical activity of PLX-200, in CLN2, CLN3, Krabbe disease, and Sandhoff disease.<\/p>\n

\u201cThese data, which we were honored to learn was accepted as a late-breaking abstract the prestigious WORLDSymposium\u2122 <\/i>2026, form the foundation of our work on PLX-200 in Krabbe disease,\u201d<\/i> said Lisa Bollinger, M.D., Polaryx Therapeutics Chief Medical Officer. \u201cAs one of the four indications in our Phase 2 SOTERIA basket trial, we continue to reinforce our commitment to addressing significant unmet needs across lysosomal storage disorders and are excited about the ongoing preparations of SOTERIA.\u201d<\/p>\n

The SOTERIA trial represents a flexible and resource\u2011efficient opportunity to validate PLX\u2011200\u2019s preclinical science across multiple LSDs while gathering data important in planning PLX\u2011200\u2019s future development pathway. Polaryx received a safe to proceed letter in October 2025 from the FDA and is actively planning with its contract research organization (CRO) to initiate the trial in the first half of 2026.<\/p>\n

Shrijay Vijayan, Ph.D., MBA, Polaryx Therapeutics Chief Scientific and Business Development Officer, will present preclinical findings in an oral presentation on PLX-200 in a mouse model of Krabbe disease. The presentation details are as follows:<\/p>\n

\n Title<\/b>:\u00a0<\/b>Gemfibrozil attenuates disease progression in mouse model of Krabbe disease: Basis for the initiation of SOTERIA, a phase 2 clinical trial of PLX-200 (newly formulated gemfibrozil) in lysosomal disorders
Presentation Type<\/b>:\u00a0Oral
Presenter<\/b>:\u00a0<\/b>Shrijay Vijayan, Ph.D., MBA, Chief Scientific and Business Development Officer, Polaryx Therapeutics, Inc.
Date<\/b>:\u00a0 Friday, February 6, 2026
Time<\/b>: 9:00am PST<\/p>\n

\n About PLX-200<\/b>
\n
Polaryx\u2019s lead drug candidate, PLX-200, is an orally available compound comprised of gemfibrozil. Gemfibrozil is an FDA-approved lipid regulating agent in the fibrate family which has only been approved in a capsule form for adult patients with very high elevations of serum triglyceride levels to decrease serum triglycerides and very low-density lipoprotein cholesterol and increase high density lipoprotein cholesterol. The ability of gemfibrozil to cross the blood-brain barrier (\u201cBBB\u201d) has also been documented in third-party preclinical trials and safe use of gemfibrozil in adults has also been well-established over several decades of clinical investigation and commercial use, which we believe accelerates clinical development and reduces associated costs. Although pediatric patients have been treated with gemfibrozil through small-scale compassionate use programs across several pediatric indications, including CLN2, gemfibrozil has never been approved to treat any indications in pediatric patients. We believe the unique ability of PLX-200 to cross the BBB, along with its widely applicable mechanism of action, positions PLX-200 to potentially address the immense unmet need in multiple rare, catastrophic LSD indications.<\/p>\n

\n About the SOTERIA Trial
<\/b>SOTERIA is a Phase 2, open-label, single arm trial intended to assess the safety, tolerability, and clinical activity of Polaryx\u2019s lead drug candidate, PLX-200, in CLN2, CLN3, Krabbe disease, and Sandhoff disease, four different LSDs whose patient populations Polaryx believes represent approximately one quarter of the LSD population. SOTERIA is designed to be flexible, resource-efficient, and provide important data and information important to PLX-200\u2019s future clinical development.\u00a0 Polaryx received a safe to proceed letter in October 2025 from the FDA and plans to initiate SOTERIA in the first half of 2026 in trial sites in the United States as well as in Europe and Asia or other foreign jurisdictions. Designed with a high degree of flexibility, SOTERIA represents a resource-efficient opportunity to validate PLX-200\u2019s preclinical science across multiple LSDs while gathering data that will be invaluable in planning PLX-200\u2019s future development pathway, including the initiation of potentially pivotal trials. For the CLN2 and CLN3 cohorts, although the entire trial is open label, these cohorts will incorporate analyses comparing natural history data as a control arm to PLX-200\u2019s treated arm. A natural history study is a preplanned observational study intended to track the course of the disease. Should the data demonstrate compelling clinical activity, Polaryx may seek conditional marketing authorization.<\/p>\n

\n About Polaryx Therapeutics\u00a0
<\/b>Polaryx Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing patient-friendly small molecule and gene therapy treatments for rare orphan lysosomal storage disorders (LSDs). Founded in 2014, Polaryx seeks to deliver safe, effective, and patient-friendly treatments that address the underlying pathophysiology of these catastrophic diseases and their significant unmet need. Our approach integrates small molecule therapies, including a combination therapy, and a gene therapy, positioning us to potentially address both the genetic and downstream pathological features of LSDs. Our small molecule drug candidates share similar modes of action that have been demonstrated to address lysosomal dysfunction, neuroinflammation, and neuronal loss in our validated animal models that closely mimic human clinical phenotypes. Our most advanced product candidate, PLX-200, targets several LSDs and we intend to launch SOTERIA, a Phase 2 basket trial, to evaluate PLX-200\u2019s safety and efficacy. For more information, please visit www.polaryx.com<\/a>.<\/p>\n

\n Forward-Looking Statements
<\/b>Certain statements in this press release may constitute \u201cforward-looking statements\u201d within the meaning of the federal securities laws, including, but not limited to, statements regarding: Polaryx\u2019s clinical development plans for PLX-200, including the timing for initiation of the SOTERIA trial. Words such as \u201cmay,\u201d \u201cmight,\u201d \u201cwill,\u201d \u201cobjective,\u201d \u201cintend,\u201d \u201cshould,\u201d \u201ccould,\u201d \u201ccan,\u201d \u201cwould,\u201d \u201cexpect,\u201d \u201cbelieve,\u201d \u201cdesign,\u201d \u201cestimate,\u201d \u201cpredict,\u201d \u201cpotential,\u201d \u201cdevelop,\u201d \u201cplan\u201d or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Polaryx believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Polaryx\u2019s filings with the U.S. Securities and Exchange Commission (the SEC), many of which are beyond the company\u2019s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Polaryx\u2019s clinical trials; expectations regarding the timing, completion and outcome of Polaryx\u2019s clinical trials; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Polaryx\u2019s Registration Statement on Form S-1, as amended, filed with the SEC on January 27, 2026 and subsequent disclosure documents Polaryx may file with the SEC. Polaryx claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Polaryx expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.<\/p>\n

\n Media Contact:<\/b>
\n
Jules Abraham
Managing Director, Communications
CORE IR
(212) 655-0924
Julesa@coreir.com<\/a><\/p>\n

\n Investor Contacts:<\/b>
\n
CORE IR
(212) 655-0924
investor@polaryx.com<\/a>\u00a0<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

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

Oral presentation provides additional scientific rationale on Krabbe disease, one of four LSDs in the Phase 2 SOTERIA basket trial designed to evaluate the safety and clinical activity of lead drug candidate PLX-200 PARAMUS, NJ, Feb. 03, 2026 (GLOBE NEWSWIRE) — Polaryx Therapeutics (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (\u201cLSDs\u201d), announces it will be presenting a late-breaking abstract on new data for PLX-200, an investigational therapy for the treatment of Krabbe disease (globoid cell leukodystrophy) at the 22nd Annual WORLDSymposium\u2122, held February 2-6, 2026 in San Diego, Calif. These data support the continued advancement on progressing the launch of the SOTERIA trial, a Phase 2, open-label, single arm trial intended … <\/p>\n

Continue reading “Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-933661","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nPolaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Oral presentation provides additional scientific rationale on Krabbe disease, one of four LSDs in the Phase 2 SOTERIA basket trial designed to evaluate the safety and clinical activity of lead drug candidate PLX-200 PARAMUS, NJ, Feb. 03, 2026 (GLOBE NEWSWIRE) — Polaryx Therapeutics (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (\u201cLSDs\u201d), announces it will be presenting a late-breaking abstract on new data for PLX-200, an investigational therapy for the treatment of Krabbe disease (globoid cell leukodystrophy) at the 22nd Annual WORLDSymposium\u2122, held February 2-6, 2026 in San Diego, Calif. These data support the continued advancement on progressing the launch of the SOTERIA trial, a Phase 2, open-label, single arm trial intended … Continue reading "Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-03T13:38:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY0NzU3NyM3NDA1ODE0IzUwMDE1Njg1Mg==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch\",\"datePublished\":\"2026-02-03T13:38:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\\\/\"},\"wordCount\":1235,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTY0NzU3NyM3NDA1ODE0IzUwMDE1Njg1Mg==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\\\/\",\"name\":\"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch - 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These data support the continued advancement on progressing the launch of the SOTERIA trial, a Phase 2, open-label, single arm trial intended … Continue reading \"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/","og_site_name":"Market Newsdesk","article_published_time":"2026-02-03T13:38:19+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY0NzU3NyM3NDA1ODE0IzUwMDE1Njg1Mg==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch","datePublished":"2026-02-03T13:38:19+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/"},"wordCount":1235,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY0NzU3NyM3NDA1ODE0IzUwMDE1Njg1Mg==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/polaryx-to-present-late-breaker-data-related-to-soteria-at-the-22nd-annual-worldsymposium-as-company-prepares-for-soteria-trial-launch\/","name":"Polaryx to Present Late-Breaker Data Related to SOTERIA at the 22nd Annual WORLDSymposium\u2122 as Company Prepares for SOTERIA Trial Launch - 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