Olatec Therapeutics Presented Preclinical Evidence of Disease-Modifying Activity with Dapansutrile in its Parkinson’s Studies

January 20, 2026 – Olatec Therapeutics, Inc. (“Olatec”), a clinical stage biotechnology company leading the development of specific NLRP3 inhibitors, presented preclinical data at The Michael J. Fox Foundation (MJFF) Parkinson's Disease Research Exchange forum. The studies were supported by funding from MJFF for Parkinson’s Research and conducted by Dr. Nadia Stefanova of the Medical University of Innsbruck. The results presented by Dr. Stefanova demonstrated that chronic oral treatment with dapansutrile, produces broad, durable, and clinically relevant disease-modifying effects in two translational mouse models of Parkinson’s disease (PD). Dr. Stefanova’s preclinical studies showed dapansutrile, which was orally administered for six months at a well-tolerated human-equivalent dose: Inhibited neuroinflammation (microglial and astroglial activation) Prevented or significantly improved motor deficits Protected dopaminergic neurons in the substantia nigra and striatum Reduced α-synuclein pathology and intracellular accumulation Reversed pathogenic microglial gene-expression signatures, normalizing ~75% of upregulated genes (including Lrrk2) and counteracting the disease-associated microglial phenotype identified by human single-cell RNA sequencing Lowered plasma neurofilament light (NfL) and IL-18, biomarkers that correlated strongly with motor improvement ​These effects were observed and target engagement confirmed (reduced NLRP3, ASC, cleaved caspase-1, IL-1β, IL-18) in the brain in two models ... Oct 2 Andy Cunningham Joins Olatec Therapeutics Board of Directors New York, NY – Olatec Therapeutics, Inc. , a leader in the emerging class of specific NLRP3 inhibitors, today announced that Andy Cunningham had joined its Board of Directors. She succeeds Valentín Campos, who retired from the Board after 9 years of service. Ms. Cunningham brings four decades of proven expertise in strategic communication, marketing and branding across diverse sectors ranging from technology to healthcare. Throughout her distinguished career, she has played a key role in launching several categories and businesses within the technology and healthcare industries..... Jan 28 Marc Y. Donath MD Renowned Immuno-Endocrinologist Appointed to Olatec's Clinical Advisory Board ​ NEW YORK--( BUSINESS WIRE )-- Olatec Therapeutics, Inc. , a leader in the developing class of selective NLRP3 inhibitors, today announced that long-time collaborator and advisor, Prof. Dr. Marc Donath, has joined the Company’s Clinical Advisory Board (CAB). Dr. Donath, a renowned immuno-endocrinologist, has been recently elected as Medical Director of the Diabetes Centre at the University Hospital Montreal, Canada and is Chief Physician in Endocrinology, Diabetes and Metabolism at the University of Basel, Switzerland... ​ ​ Jan 13 As we prepare to launch our pioneering investigator-initiated Phase 2 clinical trial exploring dapansutrile's potential in Parkinson's disease, we are pleased to share a compelling video presented by Cure Parkinson's in collaboration with the University of Cambridge . Hosted by the prestigious Royal Society of Medicine (RSM), this presentation provides the rationale for targeting the immune system and neuroinflammation in Parkinson’s disease with dapansutrile, a specific NLRP3 inhibitor. https://lnkd.in/eYSNHVTs Prior Years News & Events 2024 2023 2022 2021 2020 2019 2018 2017 2016 < > Nov 17 Olatec has been invited to present a scientific poster on dapansutrile, one of the most clinically advanced NLRP3 inhibitors, at the American College of Rheumatology 2024 conference, in Washington, DC. This premier event for rheumatology professionals will showcase the latest advancements and research in the field. Dapansutrile (OLT1177®), a highly specific NLRP3 inhibitor, controls inflammation by selectively targeting the inflammasome without broadly impacting other immune pathways. This specificity reduces off-target effects, potentially offering a safer therapeutic option across multiple diseases. Olatec’s lead clinical trial in acute gout flare, PODAGRA-II (NCT05658575), a Phase 2/3 study, is ongoing. Positive results from this study could transform acute gout flare treatment, offering safer and more effective inflammation management through NLRP3 inhibition. See abstract (0934) here: https://lnkd.in/ejhQmZjZ Nov 16 Olatec presented at the American Heart Association Scientific Sessions 2024 in Chicago, sharing a scientific poster on our ongoing Type-2 Diabetes (T2DM) clinical trial, DAPAN-DIA (NCT06047262). This event provides a forum for breakthroughs in cardiometabolic science and medicine, breakthroughs that have the potential to transform therapy practices for cardiometabolic conditions, obesity , and related comorbidities. Our research focuses on an urgent unmet need for T2DM patients at risk for cardiometabolic and other complications. In our completed study in heart failure, patients showed improvements in heart function (LVEF) and glycemia (fasting glucose) with dapansutrile (OLT1177®) in T2DM. Olatec’s ongoing clinical trial in T2DM patients will provide critical data on a new, clinically relevant aspect of T2DM care. We believe that dapansutrile (OLT1177®) has the potential to become a new therapeutic option for T2D patient that addresses both inflammation and cardiometabolic health. Sep 24-27 Olatec was invited to present a scientific poster on dapansutrile at EMBO Inflammasomes 2024. The EMBO Workshop is bringing researchers together to advance inflammasome biology on September 24-27 in Germany. The poster addresses the need for new assays to be able to reliably assess NLRP 3inhibitors outside of sulfonylureas chemotypes. For example, a new assay called NLRP3 NanoBRET® target engagement assay, does not adequately account for the unique molecular and binding properties of these NLRP3 inhibitors, like hashtag#dapansutrile, a sulfonylnitrile, which has shown a promising safety profile for chronic use. In their recent Frontiers paper, Tengesdal et al. (2024) highlight the crucial limitations of the NLRP3 NanoBRET® assay in evaluating inhibitors with non-sulfonylurea chemotypes like dapansutrile. Improved methods are essential for accurate screening. Sep 9-11 Olatec was selected to present BioCentury Inc Grand Rounds event September 9-11 on the clinical status of dapansutrile, our specific NLRP3 inhibitor Jul 11 First Patient Enrolled in a Phase 2 Study in Patients with Type 2 diabetes with Olatec's NLRP3 Inhibitor, Dapansutrile The first patient with type 2 diabetes mellitus (T2D) and diabetes-related complications has been enrolled in a clinical trial called DAPAN-DIA in Basel, Switzerland, with Olatec's NLRP3 inhibitor, dapansutrile, which is sponsored by Principal Investigator, Marc Donath MD This Phase 2 randomized study is designed to evaluate dapansutrile's efficacy and safety in approximately 300 patients with elevated blood glucose, systemic inflammation and at risk for complications of diabetes, despite use of standard-of-care anti-diabetic therapy DAPAN-DIA represents the first T2D clinical trial of any selective NLRP3 inhibitor in the emerging class that will also assess cardiometabolic and other risk factors beyond anti-hyperglycemic effects including weight lowering efficacy in combination with GLP-1 therapy The trial is being funded by a consortium that includes Olatec, the European Union under the Horizon Europe Programme (GA No 101095433) and the Swiss Government as part of the INTERCEPT-T2D initiative ​ NEW YORK,

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