, /PRNewswire/ – 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: a PD prevention model (i.e., α-synuclein pre-formed fibril model) and, critically, in a PD therapeutic model initiated after symptom onset (*i.e., *PLP-α-synuclein transgenic model).

Dr Stefanova stated: "We are excited that our results generate a strong translational rationale for the clinical development of dapansutrile for PD and related disorders, not limited to the beneficial effects in mouse models, but also providing a direct mechanistic bridge between the effects of dapansutrile and the disease-associated pathogenic profile of microglia in PD".

Damaris Skouras, Co-Founder and CEO of Olatec, stated: "We are grateful to MJFF and Dr. Stefanova for enabling these studies that provide compelling mechanistic and biomarker evidence that dapansutrile can modify core neurodegenerative processes in animal models of PD." The data further strengthen the translational rationale for dapansutrile’s Phase 2 trial expected to begin enrolling soon at the University of Cambridge. If confirmed in patients who will be dosed for 12 months, dapansutrile could represent the first oral disease-modifying therapy targeting NLRP3-driven neuroinflammation in Parkinson’s."

**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, selectively blocks the NLRP3 inflammasome — a master regulator of the innate immune system’s inflammatory response. By safely inhibiting pathological inflammation while preserving normal immune function, dapansutrile has the potential to treat or prevent the progression of a wide range of acute and chronic diseases, including many conditions associated with aging.

Olatec has advanced dapansutrile from discovery to its current later-stage clinical development in arthritis, diabetes, neuroinflammatory diseases and cancer. Dapansutrile’s clinical leadership and differentiation is supported by:

• Clinical Pipeline: Olatec is currently conducting the largest and most advanced stage dapansutrile trials across the broadest range of indications
• Safety Profile: Dapansutrile’s has a clean safety record with dosing out to two years in humans —essential for restoring immune balance over very long-term chronic dosing
• Published Efficacy Data: Olatec is the only NLRP3-focused company with peer-reviewed publications demonstrating multiple efficacy signals in numerous human and animal studies
• **Balanced Inhibition of NLRP3i: **dapansutrile was designed to provide sustained but not complete blockade of the NLRP3 inflammasome while treating pathological inflammation. Avoiding total suppression of NLRP3 activity is necessary to preserve essential host-defense

The Company’s preclinical and clinical studies have been published in top medical and scientific journals such as The Lancet, Proceedings of National Academy of Sciences, Journal of Cardiovascular Pharmacology. On the strength of dapansutrile’s favorable safety profile and signals of efficacy across multiple indications, our clinical trials are now being conducted in well-known international centers of excellence such as Duke Cancer Institute in collaboration with Merck, the rheumatology department at NYU Langone, the neurosciences clinic at the University of Cambridge, and the immuno-endocrinology department at the University of Basel.

Our 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.

***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.

SOURCE Olatec Therapeutics, Inc.