{"id":766573,"date":"2023-06-28T07:14:55","date_gmt":"2023-06-28T11:14:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/synlogic-announces-international-nonproprietary-name-selection-for-synb1934\/"},"modified":"2023-06-28T07:14:55","modified_gmt":"2023-06-28T11:14:55","slug":"synlogic-announces-international-nonproprietary-name-selection-for-synb1934","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/synlogic-announces-international-nonproprietary-name-selection-for-synb1934\/","title":{"rendered":"Synlogic Announces International Nonproprietary Name Selection\u00a0for SYNB1934"},"content":{"rendered":"
\n

\n The World Health Organization has approved \u201clabafenogene marselecobac\u201d<\/em>
\n \n <\/p>\n

\n Name attributes recognize Synlogic\u2019s proprietary technology\u00a0<\/em>
\n and commitment to phenylketonuria community<\/em>\n <\/p>\n

CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) — Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that the International Nonproprietary Names (INN) Expert Committee of the\u00a0World Health Organization (WHO-INN)<\/a>\u00a0has selected “labafenogene marselecobac<\/em>” for the nonproprietary name of the company\u2019s investigational drug for phenylketonuria (PKU), previously known as SYNB1934. Naming attributes recognize Synlogic\u2019s proprietary technology and the company\u2019s deep appreciation for, and commitment to, the PKU community.<\/p>\n

Labafenogene marselecobac is currently being evaluated in Synpheny-3, a global pivotal clinical trial designed to evaluate the efficacy and safety of the investigational drug as a treatment for PKU. For more information about the Synpheny-3 clinical trial, visit www.pkuresearchstudy.com<\/a>.<\/p>\n

\u201cOn the heels of initiating Synpheny-3, our pivotal study for people living with PKU, receiving this INN marks another milestone as we advance this potentially transformational therapeutic to the many patients living with PKU who remain in need of a new medical treatment,\u201d said\u00a0Aoife Brennan, M.B. Ch.B.,\u00a0Synlogic President and Chief Executive Officer. \u201cWith this name, we recognize PKU heroes: Mary and Sheila Jones, whose experience demonstrated the life-changing effect of Phe control in PKU. Mary and Sheila are honored in the prefix of this INN, \u2018marsel<\/em>ecobac,\u2019 and it is fitting that we announce this tribute on June 28: International PKU Awareness Day. It is our privilege to share and celebrate this milestone with those living with PKU around the world.\u201d<\/p>\n

\n About labafenogene marselecobac (SYNB1934)<\/strong>\n <\/p>\n

Labafenogene marselecobac (SYNB1934) is an orally administered, non-systemically absorbed, potential treatment for phenylketonuria (PKU), a rare metabolic disease caused by inherited mutations that impair the breakdown of phenylalanine (Phe), an amino acid found in all protein-containing foods. The goal of PKU management is to reduce plasma Phe below neurotoxic levels, reducing risk of neurocognitive complications. Current treatment options for PKU are limited due to safety and efficacy, leaving the majority of people living with PKU without medical management and with uncontrolled Phe. Synlogic\u00a0designed labafenogene marselecobac to target and consume Phe in the GI tract, by applying precision genetic engineering to a well-characterized probiotic. Results to date indicate the potential for labafenogene marselecobac as the first therapeutic for PKU approved as both a monotherapy and adjunctive medical treatment, and following successful Phase 2 results, it has advanced to Synpheny-3, a global, pivotal Phase 3 study.\u00a0Labafenogene marselecobac has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the\u00a0FDA in addition to orphan designation from the\u00a0European Medicines Agency\u00a0(EMA).<\/p>\n

\n About Synlogic <\/strong>\n <\/p>\n

Synlogic is a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases in need of new treatment options. The Company\u2019s late-stage pipeline is focused on rare metabolic diseases, led by labafenogene marselecobac (SYNB1934), currently being studied as a potential treatment for phenylketonuria (PKU) in Synpheny-3, a global, pivotal Phase 3 study. Additional product candidates address diseases including homocystinuria (HCU), enteric hyperoxaluria, gout, and cystinuria. This pipeline is fueled by the Synthetic Biotic platform, which applies precision genetic engineering to well-characterized probiotics. This enables Synlogic to create GI-restricted, oral medicines designed to consume or modify disease-specific metabolites \u2013 an approach well suited for PKU and HCU, both inborn errors of metabolism, as well as other disorders in which the disease\u2013specific metabolites transit through the GI tract, providing validated targets for these Synthetic Biotics. Research activities include a partnership with Roche focused on inflammatory bowel disease (IBD), and a collaboration with Ginkgo Bioworks in synthetic biology, which has contributed to two pipeline programs to date. For more information, please visit www.synlogictx.com<\/a> or follow us on Twitter<\/a> or LinkedIn<\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>\u00a0<\/p>\n

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” \u201clook forward,\u201d “estimate,” “expect,” “intend,” \u201con track,\u201d “plan,” “predict,” \u201cprepare\u201d and similar expressions and their variants, as they relate to\u00a0Synlogic, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements regarding the potential of\u00a0Synlogic’s\u00a0approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach\u00a0Synlogic\u00a0is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of\u00a0Synlogic’s\u00a0clinical trials of labafenogene marselecobac (SYNB1934), SYNB1353, SYNB8802 and SYNB2081 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statements as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability of\u00a0Synlogic\u00a0to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading “Risk Factors” in\u00a0Synlogic’s\u00a0filings with the\u00a0U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect\u00a0Synlogic’s\u00a0current views with respect to future events.\u00a0Synlogic\u00a0anticipates that subsequent events and developments will cause its views to change. However, while\u00a0Synlogic\u00a0may elect to update these forward-looking statements in the future,\u00a0Synlogic\u00a0specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing\u00a0Synlogic’s\u00a0view as of any date subsequent to the date hereof.\u00a0<\/p>\n

\n Media Contact: <\/strong>
\n media@synlogictx.com<\/a>\n <\/p>\n

\n Investor Relations:<\/strong>
\n investor@synlogictx.com<\/a>\n <\/p>\n

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

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

The World Health Organization has approved \u201clabafenogene marselecobac\u201d Name attributes recognize Synlogic\u2019s proprietary technology\u00a0 and commitment to phenylketonuria community CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) — Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that the International Nonproprietary Names (INN) Expert Committee of the\u00a0World Health Organization (WHO-INN)\u00a0has selected “labafenogene marselecobac” for the nonproprietary name of the company\u2019s investigational drug for phenylketonuria (PKU), previously known as SYNB1934. Naming attributes recognize Synlogic\u2019s proprietary technology and the company\u2019s deep appreciation for, and commitment to, the PKU community. Labafenogene marselecobac is currently being evaluated in Synpheny-3, a global pivotal clinical trial designed to evaluate the efficacy and safety … <\/p>\n

Continue reading “Synlogic Announces International Nonproprietary Name Selection\u00a0for SYNB1934”<\/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-766573","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nSynlogic Announces International Nonproprietary Name Selection\u00a0for SYNB1934 - 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\/synlogic-announces-international-nonproprietary-name-selection-for-synb1934\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Synlogic Announces International Nonproprietary Name Selection\u00a0for SYNB1934 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The World Health Organization has approved \u201clabafenogene marselecobac\u201d Name attributes recognize Synlogic\u2019s proprietary technology\u00a0 and commitment to phenylketonuria community CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) — Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that the International Nonproprietary Names (INN) Expert Committee of the\u00a0World Health Organization (WHO-INN)\u00a0has selected “labafenogene marselecobac” for the nonproprietary name of the company\u2019s investigational drug for phenylketonuria (PKU), previously known as SYNB1934. Naming attributes recognize Synlogic\u2019s proprietary technology and the company\u2019s deep appreciation for, and commitment to, the PKU community. 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