Full Press Release Details
J Exp Med. 2018;215(5):1315-1325. 2 Strasser S, et al. Integrative Biology. 2019;11(7):301-314. 0.8 1 1.2 1.4 1.6 1.8 2 2.2 2.4 2.6 2.8 0 5 10 15 20 Paw Volume - ml Study Day Vehicle CDD450 - 10 MPK CDD450 - 5 MPK CDD110 - 1.5 MPK Oral dosing initiated vehicle ATI-450 IL1 (bone marrow fluid) CDD-450 - + - + 0 10 20 30 40 50 60 70 ( p g ) ( n g / m l ) 0 0.5 1.0 1.5 2.0 2.5 3.0 Normal NOMID CDD-450 - + - + Normal NOMID IL6 (serum) ( p g ) 0 10 20 30 40 50 60 70 CDD-450 - + - + Normal NOMID IL18 (bone marrow fluid) ATI-450 ATI-450 ATI-450 ATI-450 PLACEBO 18 Copyright 2020 Aclaris Therapeutics, Inc.
J Exp Med. 2018;215(5):1315-1325. Inflammatory Bowel Disease Adoptive transfer mouse model of colitis - Endoscopy scores show disease control - Decreased inflammatory infiltrate - Protected structural integrity of mucosa Strasser S, et al. Integrative Biology. 2019;11(7):301-314. Cryopyrin- Associated Periodic Syndromes (CAPS) Murine NOMID (severe form of CAPS) transgenic model Human CAPS PBMC* IL1 modulation Wang C, et al.
J Exp Med. 2018;215(5):1315-1325. ATI-450 is highly selective for the p38/MK2 complex vs. other p38 substrates1 Assay Fold Selective p38 /MK2 1 p38 /ATF2 700 p38 /PRAK 750 ATI-450 binds to the p38 /MK2 complex with higher affinity than either p38 or MK2 alone** 0 20 40 60 80 100 120 1 3 5 7 9 11 13 15 1719 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63 65 67 69 71 73 75 77 79 81 83 85 87 89 91 93 95 97 99 101 p38 p38 103 105 107 109 111 113 115 117 119 121 123 125 127 131 129 133 135 137 139 141 143 145 147 151 149 153 155 157 159 161 163 165 167 171 169 173 175 177 179 181 183185189 191 193 15 Copyright 2020 Aclaris Therapeutics, Inc.
RA Psoriasis Ulcerative Colitis Crohn's Disease Atopic Dermatitis (moderate - severe) (moderate - severe) (moderate - severe) (moderate - severe) (moderate - severe) 2018E WW Sales1 ~$25B ~$15B ~$5B ~$11B ~$1B Estimated Peak Market (WW)2 ~$25-30B ~$20-25B ~$8-12B ~$15B ~$8-12B Prevalent US Moderate/Severe Population3 ~1,000K+ ~1,000-1,300K ~400-500K ~350-450K ~300-700K Opportunity for New Treatments Orals, Improved risk/benefit, novel mechanism Oral, novel mechanism, improved safety Gut-restricted (improved safety) Gut-restricted (Improved safety) Improved risk/benefit, topical in moderate to severe 7 Copyright 2020 Aclaris Therapeutics, Inc.
Something Big Is Getting Bigger [research note]. New York, NY: Credit Suisse Equity Research; 2019. 1 Estimates of total sales per indication from EvaluatePharma. 2 CS projections: based on US branded pricing. 3 Assumed peak treatable population with biologics/novel agents in the US: RA 350-400k / Psoriasis 300-350k / Ulcerative Colitis 225-275k / Crohn's 225-275k / Atopic Dermatitis 150-200k.
Led discovery and development teams in Immuno-Inflammation and Dermatology leading to multiple successful NDAs, including NUCALA & BENLYSTA * All trademarks are the property of their respective owners. Former Executive Director, Pfizer Inflammation Research and Leader of Global Kinase Technology Team >95 publications and patents (>30 total on kinases) Joseph Monahan, PhD Exec.
Director, Discovery, Early Development Former research project leader at Pfizer. Director of Chemistry at Mnemosyne, Luc, Cadent. Inventor of 6 clinical candidates and author of 40 peer reviewed publications and patents Gary DeCrescenzo SVP, Pharm R&D Former Exec. Director, Pfizer. Site Head for Medicinal & Structural Chemistry. >100 patents. Co-inventor of multiple drug candidates David Gordon Chief Medical Officer Former SVP, R&D at GSK.
This data involves 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. Cautionary Note Regarding Forward-Looking Statements 2 Copyright 2020 Aclaris Therapeutics, Inc.
Securities and Exchange Commission from time to time. These documents are available under the SEC filings" section of the Investors page 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, and 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.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. 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 have 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, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and other filings Aclaris makes with the U.S.
These statements may be identified by words such as "believe, "expect," "may, "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris' development of its drug candidates, including the timing for initiation and completion of clinical trials, the availability of data from these trials and the timing of its regulatory submissions related to these trials.