University of Liege

The marketing authorization for SKYRIZI® (risankizumab) marks its fourth approved indication in the European Union The approval is supported by data from two pivotal Phase 3 trials: The INSPIRE induction trial1 and COMMAND maintenance trial2 In both trials, SKYRIZI achieved the primary endpoint of clinical remission (per Adapted Mayo Score*) and key secondary endpoints, including mucosal healing** and histologic endoscopic mucosal healing†,1,2 NORTH CHICAGO, Ill., July 26, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission has approved SKYRIZI® (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.3 "Ulcerative colitis is a chronic, unpredictable and sometimes debilitating disease, and people living with the condition need sustained symptom relief," said Edouard Louis, M.D., Ph.D., professor and head of gastroenterology, Liège University Hospital, dean of faculty, Liège University, and INSPIRE trial investigator. "Patients treated with SKYRIZI in the INSPIRE and COMMAND clinical trials experienced significant improvements in clinical remission and mucosal healing. These are important findings as mucosal healing goes beyond symptom management to restoration of the intestinal lining and is associated with improved long-term outcomes. This approval introduces a new treatment option to help patients with UC reach their long-term treatment goals," continued Professor Louis. UC is estimated to affect 5 million people around the world, and the incidence is increasing worldwide.4 The common signs and symptoms of UC include diarrhea, abdominal pain, blood in the stool, urgency to defecate, passing mucus from the rectum and rectal pain and bleeding.5 Because of the pain and discomfort, patients commonly lack the ability or desire to pursue everyday activities.6 "The approval of SKYRIZI for the treatment of UC provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use, including conventional or biological therapy. Notably, in the Phase 3 trials we observed positive results in mucosal healing particularly in patients without previous biologic experience or JAK inhibitor failure," said Roopal Thakkar, M.D., executive vice president, research & development, and chief scientific officer, AbbVie. "The EU approval of SKYRIZI for people living with UC strengthens our diversified IBD portfolio, providing healthcare professionals with more options to treat their IBD patients." The recommended SKYRIZI induction dose is 1,200 mg administered by intravenous (IV) infusion at week 0, week 4 and week 8. Starting at week 12 and every 8 weeks thereafter, the recommended maintenance dose of either 180 mg or 360 mg administered by subcutaneous (SC) injection is based on individual patient presentation. The approval of SKYRIZI was based on two Phase 3 clinical trials, INSPIRE and COMMAND.1,2 Primary and key secondary endpoint results from the Phase 3 trials include the following: Primary Endpoint: Clinical Remission In the INSPIRE induction trial, a significantly higher proportion of patients treated with risankizumab 1,200 mg IV achieved the primary endpoint of clinical remission (per Adapted Mayo Score*) at week 12 than patients receiving placebo (20% vs 6%; p<.00001).3 In the COMMAND maintenance trial, a significantly higher proportion of patients who received risankizumab 180 mg or 360 mg SC achieved clinical remission at week 52 than patients in the induction-only control group: 40% and 38%, respectively, versus 25% (p≤.01).3 Key Secondary Endpoint: Mucosal Healing In INSPIRE, mucosal healing** was observed at week 12 in 37% of patients treated with risankizumab 1,200 mg IV compared to 12% of those receiving placebo (p<.00001).3 Specifically in patients without previous biologic or JAK inhibitor failure, 48% of patients treated with risankizumab 1,200 mg IV achieved mucosal healing at week 12 versus 14% of those receiving placebo.3 In COMMAND, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved mucosal healing at week 52 versus 32% of patients in the induction-only control group (p<.001).3 In patients without previous biologic or JAK inhibitor failure, 60% of patients who received risankizumab 180 mg and 76% who received risankizumab 360 mg achieved mucosal healing versus 36% of patients in the induction-only control group.3 Key Secondary Endpoint: Histologic Endoscopic Mucosal Healing (HEMH) In INSPIRE, 24% of patients treated with risankizumab 1,200 mg IV achieved HEMH† at week 12 versus 8% of those receiving placebo (p<.00001).1 In COMMAND, significantly more patients treated with risankizumab 180 mg and 360 mg achieved HEMH at week 52 than those treated with the induction dose only: 43% and 42%, respectively, versus 23% (p≤0.01).2 *Adapted Mayo Score is based on the stool frequency subscore (SFS), rectal bleeding subscore (RBS) and endoscopic score (ES). ** Mucosal healing is defined as ES ≤1 without friability. †HEMH is defined as Geboes score ≤3.1 and ES ≤1 without friability. The safety profile of SKYRIZI in both trials was consistent with the safety profile observed in previous trials across other indications, with no new safety risks observed. The most common adverse events observed were COVID-19, anemia, nasopharyngitis and arthralgia.1,2 Results from the INSPIRE induction and COMMAND maintenance Phase 3 trials were published in The Journal of the American Medical Association (JAMA) in July 2024. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About Ulcerative Colitis (UC) UC is a chronic, idiopathic, immune-mediated IBD of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.7,8 The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.6,9 The disease course of UC varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or life-threatening complications.6,9 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.9 About the INSPIRE Induction Trial 1 INSPIRE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of risankizumab 1,200 mg IV administered at 0, 4 and 8 weeks as induction therapy in patients with moderately to severely active UC. Topline results of the study were shared in March 2023. More information can be found on (NCT03398148). About the COMMAND Maintenance Trial 2 The COMMAND trial is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance trial designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active UC. This study followed a rerandomized withdrawal design in which all patients received risankizumab IV induction, and those with a response to risankizumab were rerandomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those patients randomized to withdraw from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 trial is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active UC with a response to risankizumab IV induction in the INSPIRE trial. Topline results from this study were shared in June 2023. More information can be found on (NCT03398135). About SKYRIZI® (risankizumab) SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit.3 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.10,11 SKYRIZI is approved by the U.S. Food and Drug Administration and the EMA for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.3,12 EU Indications and Important Safety Information About Risankizumab (SKYRIZI) 3 Indications SKYRIZI is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs. SKYRIZI is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy. Important Safety Information SKYRIZI is contraindicated in patients hypersensitive to the active substance or to any of its excipients and in patients with clinically important active infections (e.g., active tuberculosis [TB]). SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients treated with SKYRIZI should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored, and SKYRIZI should not be administered until the infection resolves. Prior to initiating treatment with SKYRIZI, patients should be evaluated for TB infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment. If a serious hypersensitivity reaction occurs, including anaphylaxis, administration of SKYRIZI should be discontinued immediately, and appropriate therapy initiated. The most frequently reported adverse reactions were upper respiratory infections (13.0 % in PSO, 15.6% in Crohn's disease and 26.2% in ulcerative colitis). Commonly (≥1/100 to <1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, eczema, fatigue, and injection site reactions. This is not a complete summary of all safety information. See the full Summary of Product Characteristics (SmPC) for SKYRIZI at . Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Gastroenterology With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in IBD, like ulcerative colitis and Crohn's disease. By innovating, learning, and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience and eye care – and with products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References 1. Louis, E. et al. (2023). "OP021 Risankizumab Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomized Phase 3 INSPIRE Study." United European Gastroenterol J. 11(8):26. 2. Louis, E. et al. (2024). "OP06 Risankizumab Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomised Phase 3 COMMAND Study." J Crohns Colitis. 18(1):i10-i12. doi: 10.1093/ecco-jcc/jjad212.0006. 3. SKYRIZI. Summary of Product Characteristics. . Accessed July 9. 2024. 4. Le Berre, C. et al. (2023). "Ulcerative Colitis." Lancet. 402(10401):571-584. doi: 10.1016/S0140-6736(23)00966-2 5. National Institute of Diabetes and Digestive and Kidney Diseases. "Ulcerative Colitis." . Updated September 2020. Accessed July 15, 2024. 6. Rapport, F. et al. (2019). "Patient Views About the Impact of Ulcerative Colitis and Its Management With Drug Treatment and Surgery: A Nested Qualitative Study Within the CONSTRUCT Trial." BMC Gastroenterol. 19(1):166. doi:10.1186/s12876-019-1085-y. 7. Gajendran, M. et al. (2019). "A Comprehensive Review and Update on Ulcerative Colitis." Dis Mon. 65(12):100851. doi:10.1016/j.disamonth.2019.02.004. 8. Crohn's & Colitis Foundation of America. "The Facts About Inflammatory Bowel Diseases." . Published November 2014. Accessed July 15, 2024. 9. Mehta, F. (2016). "Report: Economic Implications of Inflammatory Bowel Disease and Its Management." Am J Manag Care. 22(3 suppl):s51-60. 10. Duvallet, E. et al. (2011). "Interleukin-23: A Key Cytokine in Inflammatory Diseases." Ann Med. 43(7):503-511. doi:10.3109/07853890.2011.577093. 11. Moschen, A.R. et al. (2019). "IL-12, IL-23 and IL-17 in IBD: Immunobiology and Therapeutic Targeting." Nat Rev Gastroenterol Hepatol. 16(3):185-196. doi:10.1038/s41575-018-0084-8. 12. Skyrizi. Highlights of Prescribing Information. . Updated June 2022. Accessed July 15, 2024. SOURCE AbbVie

AbbVie’s Skyrizi (risankizumab-rzaa) has been approved by the European Commission (EC) to treat adults with moderately-to-severely active ulcerative colitis (UC). The interleukin-23 inhibitor has been specifically authorised for use in patients who have had an inadequate response to, lost response to, or been intolerant to conventional or biologic therapy. Estimated to affect five million people globally, UC is a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of unpredictable symptoms, including abdominal pain, bloody stools and faecal urgency, and the disease can, in some cases, lead to serious complications such as cancer. Skyrizi, which is already approved in the EU to treat Crohn’s disease, plaque psoriasis and psoriatic arthritis, is designed to block a cytokine thought to be linked to a number of chronic immune-mediated diseases. The dosing regimen for the therapy in UC includes an induction period of three 1200mg intravenous doses given every four weeks, followed by doses of 180mg or 360mg delivered every eight weeks by subcutaneous injection. The EC’s latest approval was based on positive results from two late-stage trials, including the INSPIRE study designed to evaluate the safety and efficacy of a 1200mg intravenous dose of Skyrizi given every four weeks as an induction therapy in patients with moderately to severely active UC. Also supporting the regulator’s decision was the 52-week COMMAND study, which assessed 180mg or 360mg subcutaneous doses of Skyrizi as a maintenance therapy in adults with the same condition. Both trials met their shared primary endpoint of clinical remission and achieved key secondary endpoints of endoscopic improvement, including mucosal healing and histologic endoscopic mucosal healing. “These are important findings as mucosal healing goes beyond symptom management to restoration of the intestinal lining and is associated with improved long-term outcomes,” said INSPIRE trial investigator Edouard Louis, Liège University. Roopal Thakkar, executive vice president, research and development, and chief scientific officer, AbbVie, added that the new approval “provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use”.

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, July 11, 2024 /PRNewswire/ -- Olatec Therapeutics, Inc. (Olatec), a leader in the emerging class of specific NLRP3 inhibitors, announced patients with type 2 diabetes mellitus (T2D) and diabetes-related complications (the DAPAN-DIA Study) are being enrolled in a Phase 2 clinical trial in Basel, Switzerland. Continue Reading The Phase 2 Type 2 Diabetes DAPAN-DIA study is being conducted as an investigator-sponsored study under Principal Investigator Marc Donath MD at the University Hospital of Basel in Switzerland, a long-time Olatec collaborator and advisor as well as a leading researcher-clinician in immuno-metabolism. The DAPAN-DIA Study is a randomized, double-blind, placebo-controlled multi-center trial of the efficacy and safety of dapansutrile in subjects with T2D and diabetes-related complications. Target enrollment is approximately 300 patients who, upon entry into the trial, present with low-grade inflammation, obesity and inadequately controlled glycemia (elevated HbA1c) despite use of standard anti-diabetic therapy. Patients will be treated with dapansutrile or placebo for six months. "We expect the data from this trial, including the combination with GLP-1 therapy, will be highly relevant for understanding the full potential of anti-inflammatory intervention with an NLRP3 inhibitor in this setting," shared Mustafa Noor MD, Chief Medical Officer, Olatec Therapeutics. The study is being conducted as an investigator-sponsored study under Principal Investigator Marc Donath MD at the University Hospital of Basel in Switzerland, a long-time Olatec collaborator and advisor as well as a leading researcher-clinician in immuno-metabolism. In addition to the Swiss sites, the trial is intended to be expanded at medical and scientific diabetes centers of excellence within Europe, including: Hôpital Lariboisière, Hôpital Bichat-Claude Bernard and Hôpital Cochin in Paris, France; German Diabetes Center, Düsseldorf, Germany; and University Hospital of Liège in Belgium. Funding is being provided through the INTERCEPT-T2D initiative by the European Union under the Horizon Europe Programme (GA No 101095433), in collaboration with the Swiss Government and Olatec. T2D is a chronic condition characterized by elevated levels of glucose in blood, resulting from insulin resistance and inadequate insulin secretion. The disease is often concurrent with obesity and associated with a range of complications, including cardiovascular disease, renal dysfunction, retinopathy, neuropathy, and non-alcoholic steatohepatitis, where chronic, elevated low-grade systemic inflammation and activation of NLRP3 and upregulation IL-1β are observed. Unlike existing diabetic treatments that primarily focus on glucose lowering, dapansutrile offers a novel approach to disease-course modification, by targeting the underlying NLRP3 inflammation pathway that is implicated in driving resistance to insulin action in T2D, promoting body weight gain and associated with higher cardiometabolic risks. Dr. Donath stated that, "there is a large unmet need for effective treatment of T2D that goes beyond glycemic control and addresses the underlying inflammatory component of the disease and its cardiometabolic complications. The ground-breaking DAPAN-DIA Study has the potential for dapansutrile to represent a significant step forward in the management of T2D." Olatec's Founder and CEO, Damaris Skouras, commented: "Building on our previous data in heart failure and gout, DAPAN-DIA Study represents a major milestone in the development of dapansutrile in the inter-related cardiometabolic diseases linked by chronic low-grade inflammation due to NLRP3/IL-1 activation." About Type 2 Diabetes Type 2 diabetes (T2D) is a serious, chronic condition that occurs when levels of glucose in blood are elevated because the body cannot produce any or enough of the hormone, insulin, or cannot effectively use the insulin it produces. Insufficient amount of insulin, or the inability of cells to respond to it (insulin resistance), leads to high levels of blood glucose, which is the clinical indicator of T2D and measured clinically as HbA1c. High blood sugar levels can cause damage to many of the body's organs, leading to disabling and life-threatening health complications. Life expectancy for typical patients with T2D has been estimated to be 8 years shorter and driven by 200% increased risk of all-cause mortality. Approximately 70% die from atherosclerotic cardiovascular disease, 40% develop chronic kidney disease (CKD) due to diabetic nephropathy, and almost one-third develop retinopathy. As the prevalence of T2D increases globally, the condition and its associated complications are generating considerable - - and growing - -economic burden on healthcare systems and societies. In 2021, USD $966 billion in global health expenditures were due to T2D, which represents 316% increase over the last 15 years. There are an estimated 537 million adults living with diabetes worldwide, with the total number predicted to rise to 643 million by 2030 and 784 million by 2045. (Source: IDF Atlas 2021) About Scientific Rationale for NLRP3 in Type-2 Diabetes Low-grade chronic inflammatory response is one mechanism leading to the development of insulin resistance, T2D, and associated comorbidities, including liver and kidney damage. In particular, the NLRP3 inflammasome has been shown to play a central role in orchestrating inflammation and immune responses as it is activated in response to several altered metabolic signals in T2D, leading not only to the activation of caspase-1 and production of IL-1β, but also to insulin resistance and pancreatic β cell failure. Furthermore, activation of the NLRP3 inflammasome has been shown to promote vascular inflammation, endothelial dysfunction, and plaque destabilization, contributing to the pathogenesis of atherosclerosis and cardiovascular events. Antagonism of IL-1 pathways has been shown to prevent β-cell dysfunction and to improve glycaemia, cardiovascular complications and heart failure and it may counteract other complications of diabetes. Therefore, targeting this pathway in patients with T2D may have numerous therapeutic advantages over current treatments. (Reviewed by Donath and Dinarello Nature Reviews 2019). About Dr. Marc Donath, Principal Investigator Prof. Dr. Marc Donath is the Chief Physician, Clinic of Endocrinology, Diabetes & Metabolism, University of Basel. Dr. Donath's research aims at the understanding of the pathogenesis of type 2 diabetes, specifically to identify the inflammatory process underlying failure of insulin production in type 2 diabetes. Dr. Donath's work has contributed to the concept that the innate immune system is an integral component in the regulation of metabolism and shows that modulation of the immune system with anti-inflammatory intervention may improve the overall metabolic health and reduce cardiovascular risk in patients with type 2 diabetes. About the INTERCEPT-T2D Consortium INTERCEPT-T2D, which stands for Early Interception of Inflammatory-mediated Type 2 diabetes, coordinated by Nicolas Venteclef U1151 at INSERM (French National Institute of Health and Medical Research) represents a consortium of entities including Olatec, and several established European diabetes centers in addition to the Hôpital Lariboisière, Hôpital Bichat-Claude Bernard and Hôpital Cochin in Paris, France; German Diabetes Center, Düsseldorf, Germany; and University Hospital of Liège in Belgium. Funding is being provided from both (i) European Union under the Horizon Europe Programme (GA 101095433) and (ii) the Swiss Government as part of the Horizon Europe Programme and State Secretariat for Education Research and Innovation, respectively. About Olatec Therapeutics, Inc. Olatec is a leading, clinical-stage biopharmaceutical company developing a platform of oral NLRP3 inhibitors to treat and prevent a broad spectrum of acute and chronic inflammatory diseases. The lead drug candidate, dapansutrile (lab code: OLT1177®) is a small molecule, specific NLRP3 inhibitor, currently in Phase 2/3 clinical development has demonstrated to date that it is 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). In the heart failure trial, treatment with dapansutrile in subset of subjects with diabetes led to clinically meaningful reductions in fasting glucose levels relative to placebo. Ongoing clinical trials are evaluating dapansutrile in Gout, Parkinson's and Melanoma. For a complete list of Olatec's original publications on dapansutrile in various preclinical and clinical disease areas, please refer to Olatec's publications page, here. For more information, please visit 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 the Company. 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. SOURCE Olatec Therapeutics, Inc.