Press release

Andrea Leonard-Segal, MD, FACR Joins Olatec’s Scientific Advisory Board and Becomes Medical Monitor in the Upcoming Gout Trial

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Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, today announced that Andrea Leonard-Segal, MD, FACR joins the Company’s Scientific Advisory Board (SAB), and in tandem, assumes the role of Medical Monitor in the upcoming Phase 2b trial in the lead indication, acute gout flares.

Dr. Leonard-Segal’s impressive career spans 45 years of experience in the medical field, as both regulatory expert and medical practitioner. Dr. Leonard-Segal’s regulatory expertise in drug development was established at the Food and Drug Administration (FDA), where she spent 15 years evaluating drug candidates throughout the regulatory process and ultimately when assessed for market approval. At FDA, Dr. Leonard-Segal rose to become Director of the Division of Nonprescription Clinical Evaluation, a position in which she served from 2005-2013. At FDA, she was instrumental in overseeing the development and market approval of many successful over-the-counter (OTC) products including prescription to OTC “switch” programs, supervising the development and publication of industry guidances, and providing leadership and collaboration within multidisciplinary groups at the Agency. Dr. Leonard-Segal also worked on many FDA committees focused on policy development and organized and ran FDA Advisory Committee meetings. In addition, as a board-certified internist and rheumatologist, Dr. Leonard-Segal was an attending physician at the Washington VA Medical Center which was part of the Georgetown University Division of Rheumatology where she saw patients, taught fellows, and engaged in clinical research including as an investigator in clinical pharmaceutical trials. Since leaving FDA, Dr. Leonard-Segal has been providing consultative services related to prescription and nonprescription drug development. She is Associate Clinical Professor of Medicine at the George Washington University School of Medicine and Health Sciences and remains active in patient care.

Over the past year, Dr. Leonard-Segal has been consulting for Olatec on clinical programs, contributing to trial design and execution, and providing input on regulatory submissions to FDA and global medicinal agencies. Kip Vought, Olatec’s Global Development Lead, who previously worked with Dr. Leonard-Segal when interacting with her Division at FDA, commented “I was very pleased when she originally agreed to advise Olatec and now join our SAB and take on Medical Monitoring for our upcoming gout study. Dr. Leonard-Segal shares our vision and mission for the dapansutrile development program, and her exceptional expertise and standards of excellence are a natural fit with our Team culture.”

Dr. Leonard-Segal stated, “It is my pleasure to be able to advise Olatec on the dapansutrile clinical development programs. I am optimistic that this NLRP3 inhibitor will demonstrate that it can safely and effectively treat several diseases known to be driven by inflammation and thereby improve the public health.”

Reflecting on Dr. Leonard-Segal’s joining, Olatec’s CEO & Chairman, Damaris B. Skouras said: “We are honored to have Andrea join our SAB. Andrea’s commitment to rheumatology coupled with her unparalleled regulatory expertise strengthen our efforts as we proceed to late-stage development of dapansutrile leading potentially to fastest time to market applications and approvals. We look forward to Andrea’s increased involvement.”

About Dapansutrile

Dapansutrile (lab code: OLT1177®) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL‑1β and IL‑18. NLRP3 is one of the most well characterized inflammasome sensors due to its involvement in a wide range of disorders, including sterile inflammation, infections and rare genetic autoimmune syndromes. Dapansutrile is in Phase 2 clinical development and has been well tolerated and shown to improve clinical outcomes in patients with acute gout flare (see The Lancet Rheumatology) and heart failure (see Journal of Cardiovascular Pharmacology). Dapansutrile has also been observed to have antiinflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models including arthritis, asthma, acute myocardial infarction, contact dermatitis, multiple sclerosis, melanoma and breast cancers, spinal cord injury, Alzheimer’s disease and Parkinson’s disease.

About Olatec Therapeutics LLC

Olatec is a privately held, clinical-stage biopharmaceutical company developing a platform of oral NLRP3 inhibitors to treat and prevent a broad spectrum of acute and chronic inflammatory diseases known to be mediated by IL-1. In addition to the lead compound, dapansutrile, Olatec’s platform of proprietary compounds includes approximately 60 analogues (OLT Analogues) being screened as viable drug candidates. An IP portfolio protecting Olatec’s compounds consists of over 130 patents granted, covering dapansutrile and OLT Analogues. Olatec’s drug development team is comprised of experienced management and international experts in translational medicine with unparalleled expertise in inflammation and immunology and has been involved in the discovery and development of first-line inflammation treatments in the market today. For more information, please visit http://www.olatec.com.

Disclaimer & Forward-looking Statement

The information contained herein is being provided for information purposes only. The Company 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 by the Company. 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.