{"id":1013972,"date":"2026-10-27T08:34:33","date_gmt":"2026-10-27T12:34:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/camp4-therapeutics-receives-clinical-trial-application-approval-for-phase-1-2-clinical-trial-of-cmp-002-in-patients-with-syngap1-related-disorder-in-the-european-union\/"},"modified":"2026-10-27T08:34:33","modified_gmt":"2026-10-27T12:34:33","slug":"camp4-therapeutics-receives-clinical-trial-application-approval-for-phase-1-2-clinical-trial-of-cmp-002-in-patients-with-syngap1-related-disorder-in-the-european-union","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/camp4-therapeutics-receives-clinical-trial-application-approval-for-phase-1-2-clinical-trial-of-cmp-002-in-patients-with-syngap1-related-disorder-in-the-european-union\/","title":{"rendered":"CAMP4 Therapeutics Receives Clinical Trial Application Approval for Phase 1\/2 Clinical Trial of CMP-002 in Patients with SYNGAP1-Related Disorder in the European Union"},"content":{"rendered":"
\n

\n Approval under the EU Clinical Trials Regulation builds on CAMP4\u2019s recent clearances in the United Kingdom, Australia, and Argentina to initiate the Company\u2019s global Phase 1\/2 trial of CMP-002<\/em>\n <\/p>\n

\n Company on track to initiate ASCEND clinical trial in 4Q 2026 <\/em>\n <\/p>\n

WATERTOWN, Mass., Oct. 27, 2026 (GLOBE NEWSWIRE) — CAMP4 Therapeutics Corporation<\/a> (\u201cCAMP4\u201d or \u201cthe Company\u201d) (Nasdaq: CAMP), a clinical-stage biopharmaceutical company developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels to treat a broad range of genetic diseases, today announced that it has received Clinical Trial Application (CTA) approval from the regulatory authorities and ethics committees of multiple EU countries to initiate the Company\u2019s global Phase 1\/2 ASCEND clinical trial of CMP-002, a potential first-in-class, disease-modifying therapeutic candidate for patients with SYNGAP1-related disorder, at trial sites in the European Union.<\/p>\n

\u201cCTA approval in the European Union, following our clearances in the United Kingdom, Australia, and Argentina, expands the planned global footprint of ASCEND, our first-in-human trial of CMP-002 for SYNGAP1-related disorder, and gives more families the opportunity to participate closer to home,\u201d said Josh Mandel-Brehm, President and Chief Executive Officer of CAMP4. \u201cWe remain focused in the near term on enrolling the ASCEND trial to advance CMP-002 for patients who currently have no approved disease-modifying treatment options.\u201d<\/p>\n

This CTA approval follows CAMP4\u2019s July 2026 clearances to initiate the Phase 1\/2 clinical trial from Australia\u2019s Therapeutic Goods Administration (TGA) and local Human Research Ethics Committee (HREC), Argentina\u2019s Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT), and the Company\u2019s September 2026 authorization from the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency (MHRA). The Company anticipates dosing the first patient in 4Q 2026.<\/p>\n

\n About SYNGAP1-Related Disorder<\/strong>\n <\/p>\n

SYNGAP1-related disorder (also referred to as SYNGAP1) is a rare, haploinsufficient CNS disorder caused by mutations in the SYNGAP1<\/em> gene, resulting in approximately 50% of normal SYNGAP protein levels. The condition affects over 10,000 individuals in the United States and is characterized by intellectual disability in 100% of patients, epilepsy in approximately 85%, severe behavioral problems in approximately 70%, sleep problems in approximately 60%, and limited communication, with approximately 30% of patients being non-verbal. There are currently no approved disease-modifying therapies for patients living with SYNGAP1.<\/p>\n

\n About CMP-002<\/strong>\n <\/p>\n

CMP-002 is CAMP4\u2019s lead investigational antisense oligonucleotide (ASO) therapeutic candidate designed to bind to a SYNGAP1-specific regRNA to increase SYNGAP1 gene expression and restore SYNGAP protein toward near wild-type levels. Administered intrathecally, CMP-002 has demonstrated dose-dependent increases in SYNGAP protein expression in patient-derived neurons, reversal of disease-relevant behavioral phenotypes in a humanized haploinsufficient mouse model, statistically significant improvement of seizure phenotypes and parameters in a chemically induced seizure mouse model, and broad brain distribution with significant SYNGAP protein upregulation in non-human primates.<\/p>\n

\n About CAMP4 Therapeutics<\/strong>\n <\/p>\n

CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4\u2019s proprietary RAP Platform\u00ae<\/sup> enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. For more information, visit camp4tx.com<\/a>.\u00a0\u00a0\u00a0<\/p>\n

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

This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are 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 words. Forward-looking statements include, but are not limited to, statements concerning the initiation of the Phase 1\/2 ASCEND clinical trial of CMP-002; the potential of the Company\u2019s platform technology; the Company\u2019s strategy, goals, business plans and focus; the therapeutic potential of the Company\u2019s product candidates; the Company\u2019s plans for its early discovery pipeline, including its SHANK3 program, and the Company\u2019s cash runway guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company\u2019s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company\u2019s limited operating history, incurrence of substantial losses since the Company\u2019s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company\u2019s need for substantial additional financing to achieve the Company\u2019s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company\u2019s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company\u2019s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company\u2019s ability to realize the benefits of the Company\u2019s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company\u2019s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company\u2019s dependence on the services of the Company\u2019s senior management and other clinical and scientific personnel, and the Company\u2019s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company\u2019s ability to grow the Company\u2019s organization, and manage the Company\u2019s growth and expansion of the Company\u2019s operations; risks related to the manufacturing of the Company\u2019s product candidates, which is complex, and the risk that the Company\u2019s third-party manufacturers may encounter difficulties in production; the Company\u2019s ability to obtain and maintain sufficient intellectual property protection for the Company\u2019s product candidates or any future product candidates the Company may develop; the Company\u2019s reliance on third parties to conduct the Company\u2019s preclinical studies and clinical trials; the Company\u2019s compliance with the Company\u2019s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company\u2019s product candidates; risks related to the operations of the Company\u2019s suppliers; and other risks and uncertainties described in the section \u201cRisk Factors\u201d in the Company\u2019s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as other information the Company files with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. 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 the Company\u2019s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.<\/p>\n

\n Contacts<\/strong>\n <\/p>\n

\n Investor Relations:<\/strong>
\n
Sara Michelmore
Milestone Advisors
sara@milestone-advisorsllc.com<\/p>\n

\n Media:<\/strong>
\n
Sofia Bermudez
LifeSci Communications
sbermudez@lifescicomms.com<\/p>\n

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

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

Approval under the EU Clinical Trials Regulation builds on CAMP4\u2019s recent clearances in the United Kingdom, Australia, and Argentina to initiate the Company\u2019s global Phase 1\/2 trial of CMP-002 Company on track to initiate ASCEND clinical trial in 4Q 2026 WATERTOWN, Mass., Oct. 27, 2026 (GLOBE NEWSWIRE) — CAMP4 Therapeutics Corporation (\u201cCAMP4\u201d or \u201cthe Company\u201d) (Nasdaq: CAMP), a clinical-stage biopharmaceutical company developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels to treat a broad range of genetic diseases, today announced that it has received Clinical Trial Application (CTA) approval from the regulatory authorities and ethics committees of multiple EU countries to initiate the Company\u2019s global Phase 1\/2 ASCEND clinical … <\/p>\n

Continue reading “CAMP4 Therapeutics Receives Clinical Trial Application Approval for Phase 1\/2 Clinical Trial of CMP-002 in Patients with SYNGAP1-Related Disorder in the European Union”<\/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-1013972","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCAMP4 Therapeutics Receives Clinical Trial Application Approval for Phase 1\/2 Clinical Trial of CMP-002 in Patients with SYNGAP1-Related Disorder in the European Union - 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\/camp4-therapeutics-receives-clinical-trial-application-approval-for-phase-1-2-clinical-trial-of-cmp-002-in-patients-with-syngap1-related-disorder-in-the-european-union\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CAMP4 Therapeutics Receives Clinical Trial Application Approval for Phase 1\/2 Clinical Trial of CMP-002 in Patients with SYNGAP1-Related Disorder in the European Union - 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