First Parkinson's Patients Treated in Landmark Phase 2 Trial of Dapansutrile - Expanding a Leading Oral NLRP3 Inhibitor into Neurological Diseases

NEW YORK, March 24, 2026 /PRNewswire/ -- Olatec Therapeutics, Inc. ("Olatec"), developing one of the most clinically advanced specific oral NLRP3 inhibitors, dapansutrile, today announced that two patients have been randomized in a 12-month clinical trial, named DAPA-PD, for the treatment of Parkinson's disease (PD).

This milestone launches dapansutrile into Phase 2 clinical development for neurological conditions, expanding upon ongoing trials with dapansutrile in rheumatologic diseases (Phase 2/3 gout), oncology (Phase 2 advanced melanoma), and cardiometabolic disorders (Phase 2 type 2 diabetes). As a specific oral NLRP3 inhibitor, dapansutrile targets the core inflammatory mechanism shown to fuel disease progression across numerous age-related rheumatologic, oncologic, cardiometabolic, and neurologic disorders.  Dapansutrile offers potential for disease modification as monotherapy or as a complement to existing treatments by directly addressing the shared pathological inflammatory driver in these conditions.  Developing dapansutrile across multiple inflammation-based diseases is supported by its remarkably favorable safety and tolerability profile observed across preclinical studies and clinical trials in diverse disease populations, positioning it as a highly promising chronic therapy with wide therapeutic use.

The DAPA-PD trial is a single-center randomized, double-blind, placebo-controlled study being conducted at Cambridge University Hospitals NHS Foundation Trust/University of Cambridge under principal investigator, Dr. Caroline Williams-Gray, BMBCh, FRCP, PhD, and funded by Cure Parkinson's and Van Andel Institute through the International Linked Clinical Trials program.  This first 12-month duration study with an NLRP3 inhibitor in PD is designed to evaluate the safety and tolerability of dapansutrile treatment in subjects with early-stage PD, as well as its impact on inflammation, pharmacokinetics, and preliminary efficacy.  Key endpoints include changes in systemic and neuroinflammatory biomarkers (e.g., C-reactive protein, inflammatory cytokines, and PET brain imaging). Clinical outcomes will also be assessed.

Dr. Caroline Williams-Gray stated, "There is a major unmet need for disease-modifying treatments for Parkinson's to slow down the development of associated balance problems, falls, and dementia. Our research studies have shown that inflammation in people with Parkinson's is linked to faster disease progression – and therapies targeting inflammatory mechanisms could potentially make a real difference to patients and their families. This trial represents a critical step forward in advancing the development of anti-inflammatory therapies for this disease."

The DAPA-PD trial builds on compelling preclinical evidence of dapansutrile's disease-modifying potential in Parkinson's, from studies conducted at Medical University of Innsbruck under Nadia Stefanova, MD, PhD, recently published in the Journal of Neuroinflammation. This work was supported by a grant from The Michael J. Fox Foundation for Parkinson's Research.  These studies demonstrated that selective NLRP3 inhibition with dapansutrile was associated with reduced motor impairment and dopaminergic neurodegeneration.

"The initiation of this Phase 2 study advances our broader mission to transform treatment of inflammation-driven cardiometabolic and neurological diseases," said Olatec CEO, Damaris Skouras. "As a specific inhibitor of NLRP3 with a clean safety record to date that supports long-term administration, dapansutrile holds considerable potential as an oral therapy capable of modulating a shared core inflammatory mechanism that could deliver disease-modifying effects across a range of pathologies."

About Olatec Therapeutics, Inc.
Olatec is a clinical-stage biotech company at the forefront of an emerging class of innovative, oral inflammation therapeutics, called NLRP3 inhibitors.  Dapansutrile, Olatec's proprietary oral NLRP3 inhibitor, specifically modulates the NLRP3 inflammasome, known as a master regulator of the innate immune system's inflammatory response.  Olatec has advanced dapansutrile from discovery into later-stage clinical development and its mission is to translate scientific potential into the medical standard for the management of chronic, age-related diseases across multiple therapeutic areas and for expanding health span with a cost-effective and patient-friendly (orally dosed) therapeutic. 

Olatec's preclinical and clinical research have been published in top medical and scientific journals such as The Lancet, Journal of Neuroinflammation, Proceedings of National Academy of Sciences and Frontiers in Immunology.  Multiple clinical trials are being conducted at internationally recognized centers of excellence such as Duke Cancer Institute in collaboration with Merck and the neurosciences clinic at the University of Cambridge.

About Dapansutrile
Dapansutrile is Olatec's proprietary oral inhibitor of the NLRP3 inflammasome, designed to specifically inhibit chronic pathological inflammation while preserving normal immune function. By modulating a central driver of the innate immune response, we believe dapansutrile has the potential to address a broad range of acute and chronic inflammatory diseases, including many conditions associated with aging.

Dapansutrile is being studied in some of the largest ongoing clinical trials of an NLRP3 inhibitor to date evaluating efficacy and safety across multiple therapeutic indications. Dapansutrile has demonstrated a favorable safety profile, and signals of efficacy have been observed in both human and animal studies, supporting its continued clinical development.

Disclaimer & Forward-looking Statement
This press release is not an offer to sell and is not soliciting an offer to buy any equity interests in Olatec. The information contained herein is being provided for information purposes only. Olatec makes no express or implied representation or warranty as to the completeness of this information. Any forward-looking statements contained in this release are based on assumptions made by Olatec at the time this Press Release was prepared.  Any forward-looking statement contained in this Press Release is subject to known and unknown risks, uncertainties and other factors that may be materially different from those contemplated in such forward-looking statements. All information with respect to industry data has been obtained from sources believed to be reliable and current, but the accuracy thereof cannot be guaranteed. Olatec does not undertake any obligation to update or revise the forward-looking statements contained in this Press Release to reflect events or circumstances occurring after the date this Press Release was prepared, or to reflect the occurrence of unanticipated events. 

About Cure Parkinson's 
Cure Parkinson's are working with urgency to find new treatments to slow, stop and reverse Parkinson's. Cure Parkinson's funding and innovation has redefined the field of Parkinson's research, enabling the world's leading researchers to prioritize the next generation of drugs for clinical trials.

Cure Parkinson's is the operating name of The Cure Parkinson's Trust. The Cure Parkinson's Trust is a registered charity in England and Wales (1111816) and Scotland (SCO44368) and is a company limited by guarantee – company number 05539974 (England and Wales).

Funding statement
Funding for the DAPA-PD trial has been provided by Cure Parkinson's and Van Andel Institute, as a part of their International Linked Clinical Trials Program

SOURCE Olatec Therapeutics, Inc.