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Robinson MF, et al. [published online ahead of print, 2020 May 18]. Arthritis Rheumatol. 2020; 5. Russell SM, et al. Science. 1995;270(5237):797 - 800 - ATI - 2138 covalently blocks ITK/JAK3 1 Potential for synergistic efficacy - ITK required for T cell receptor (TCR) signaling - JAK3 required for IL2R common cytokines (IL - 2/4/7/9/15/21) - JAK3 is the only JAK that is inhibited - Tissue restricted expression could enhance safety - ATI - 2138 is selective for T cell signaling 2,3 - ATI - 2138 has the potential to treat T cell - mediated autoimmune diseases 4,5 - Phase 1 Single Ascending Dose Study successfully completed - New IND submitted to Division of Gastroenterology in October 2022 - Phase 1 Multiple Ascending Dose Study initiated - Phase 2a Proof of Concept study in Ulcerative Colitis under development Background Status Copyright 2020 Aclaris Therapeutics, Inc.
Medscape. Accessed January 7, 2023. https://emedicine.medscape.com/article/1049085 - overview . 2. Silverberg J. Dermatol Clin. 2017;Jul;35(3):283 - 289; 3. Auster M, et al. Something Big Is Getting Bigger [research note]. Credit Suisse Equity Research; 2019; 4. Shreberk - Hassidim R, et al. J Am Acad Dermatol. 2017;Apr;76(4):7 45 - 753. Goal Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin condition 1 - The U.S. prevalence of AD is reported to be 11.3 12.7% in children and 6.9 7.6% in adults 2 - Market projected to be $8 - 12 billion at peak (moderate to severe AD) 3 - Systemic and topical JAK inhibition has demonstrated promising results in AD clinical trials 4 - Comparable efficacy to other topical JAKs but a soft drug to minimize the potential for systemic toxicities - JAK1/3 selective to minimize JAK2 mediated hematopoietic effects - Patients with moderate to severe AD - Deliver in a patient - friendly formulation ATI - 1777 (investigational compound) - First - in - human Phase 2a trial in subjects with moderate to severe AD completed - 4 - week trial in subjects with moderate to severe AD completed with primary endpoint of % change from baseline in mEASI - Phase 2b dose ranging study underway Copyright 2020 Aclaris Therapeutics, Inc.
J Exp Med. 2018;215(5):1315 - 1325; Cheung P, et al. EMBO J. 2003;22(21):5793 - 5805; Muniyappa H, et al. Cell Signal. 2008;20(4):675 683;. Ma W, et al. J Biol Chem. 2001;276(17):13664 - 13674. The Path From p38 to MK2 p38 was initially targeted for suppressing TNF and other pro - inflammatory cytokines Global p38 inhibitors have exhibited toxicity and/or lack of sustained efficacy tachyphylaxis in RA and IBD p38 phosphorylates over 60 substrates yet MK2 drives the pro - inflammatory node of this pathway MK2 has been a high priority therapeutic target since 1999 but has proven very difficult to drug Inflammatory/Stress Stimuli p38 Anti - inflammatory Negative Feedback Cellular Function Pro - inflammatory MK2 TNF IL17 IL1 / IL6 IL8 Copyright 2020 Aclaris Therapeutics, Inc.
Unexplored opportunities in the druggable human genome. Nature Rev Drug Discov. Poster Jan. 2017; 4. Manning G, et al. Science. 2002;298(5600):1912 - 1934; 5. Oprea TI, et al. Nat Rev Drug Discov. 2018;17(5):31 7 - 332. Medically Important and Productive Target Class Most Members of the Kinome Remain Unexplored Oncology Non - Oncology >70 Marketed Drugs 1 ~$48B 2,3 Annual Sales of Kinase Drugs 518 Members >90% of the Human Kinome remains undrugged 5 Creating New Medicines Targeting Previously Inaccessible Kinome Targets 4 Copyright 2020 Aclaris Therapeutics, Inc.
These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk Copyright 2020 Aclaris Therapeutics, Inc.
Securities and Exchange Commission from time to time. These documents are available under the SEC Filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward - looking statements speak only as of the date of this presentation and are based on information available to Aclaris as of the date of this presentation, an d Aclaris assumes no obligation to, and does not intend to, update any forward - looking statements, whether as a result of new information, future events or otherwise This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry.
Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always hav e full control, the uncertainty regarding the COVID - 19 pandemic including its impact on the timing of Aclaris' regulatory and research and development activities, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10 - K for the year ended December 31, 2021 and other filings Aclaris makes with the U.S.
These forward - looking statements include expectations regarding Aclaris' development of its drug candidates, including the timing of its clinical trials and regulatory submissions, and its expected cash runway. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.