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This portfolio also includes an issued patent in Europe for tofacitinib or decernotinib for use in treating hair loss disorders and a pending European application for ruxolitinib or baricitinib to treat hair loss disorders, 3 issued patents in Japan to ruxolitinib, baricitnib, tofacitinib (topically or as monotherapy) and a pending Japanese application, and 1 issued patent in South Korea to methods of treating hair loss disorders using JAK 1 and/or JAK 2 inhibitors and 2 pending applications in South Korea to methods of treating hair loss disorders using JAK3 inhibitors.
Aclaris Therapeutics, Inc. Investigational Selective JAK 1/3 Inhibitors Portfolio and IP Estate: ATI-501 JAK1/JAK3 inhibitors Oral treatment for alopecia totalis and alopecia universalis ATI-1777 JAK1/JAK3 inhibitors Soft Topical treatment for atopic dermatitis, alopecia areata, and vitiligo ATI-502 JAK1/JAK3 inhibitors Topical treatment for hair loss disorders: patchy alopecia areata and androgenetic alopecia 19 Copyright 2019 Aclaris Therapeutics, Inc.
Current Status - Phase 3 Data expected 2H19. Summary of WART-203 Phase 2 Trial Results Trial Trial Design Trial Outcome WART 203 (N=159) - A randomized, double-blind, vehicle-controlled, parallel-group study of investigational drug A- 101 45% topical solution in subjects with 1-6 common warts - Self-treated twice weekly for a total of 16 treatments - Efficacy: Statistically significant results on all primary and secondary endpoints - Favorable safety profile 13 Copyright 2019 Aclaris Therapeutics, Inc.
Laser Treatment of Nongenital Verrucae A Systematic Review. JAMA Dermatology. 2016;152(9):1025-1033. 3 IMS National Disease and Therapeutic Index 2016. 4 Lipke M., An Armamentarium of Wart Treatments, Clinical Medicine & Research,4:4, 2006; 273 293. treated by Primary Care Physicians (2.5 avg. visits)1 treated by Dermatologists (2.6 avg. visits) 31% of pts are referrals1 61% 39% 19 22 MM1,2 - 50% of all patient visits for warts are for common warts3 - 3x more patient visits than genital warts3 - 50% of patients report moderate to extreme discomfort4 - 39% of patients say warts impact social/leisure activities4 - Unmet Needs1: - Would prefer pain-free treatments which work faster and do not have unwanted side effects 11 Copyright 2019 Aclaris Therapeutics, Inc.
(the stabilized cream) - USP No. 9,974,773 (Exp 6/11/35) - Method of treating facial erythema associated with rosacea comprising topically administering once daily to the site of erythema on the face of the patient a pharmaceutical composition comprising 1.0% or 1.5% w/w oxymetazoline HCl thereof as the sole active ingredient - Pending applications - Families related to Orange Book listed patents have pending applications in the U.S. - Pending applications are directed to, for example, methods of treating facial erythema using 1.0% oxymetazoline administered once daily; cream formulations of oxymetazoline; method of treating erythema, telangiectasia or inflammatory lesions associated with rosacea comprising topically administering formulations of oxymetazoline - Corresponding pending/issued applications in major international jurisdictions Core Intellectual Property: RHOFADE 8 Copyright 2019 Aclaris Therapeutics, Inc.
Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens. The most common side effects of RHOFADE Cream include application-site reactions of: skin reactions (dermatitis), worsening of rosacea pimples, itching, redness, and pain. Copyright 2019 Aclaris Therapeutics, Inc.
IMPORTANT SAFETY INFORMATION AND WARNINGS WARNINGS AND PRECAUTIONS Potential Impacts on Cardiovascular Disease Alpha-adrenergic agonists may impact blood pressure. RHOFADE cream should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension.
Last accessed on March 30, 2019. Currently available treatments have modest therapeutic effect and significant limitations4 ANDROGENETIC ALOPECIA (MALE / FEMALE PATTERN HAIR LOSS) VITILIGO 1-2% of global population impacted5 VERRUCA VULGARIS (COMMON WARTS) 5-7MM people in U.S. ALOPECIA AREATA (AA) ~50MM men / ~30MM women SEBORRHEIC KERATOSIS (SK) ESKATA (hydrogen peroxide) topical solution, 40% (w/w), first FDA-approved topical treatment for raised SKs in adults 83+MM people in U.S.*1 have or will develop AA2,7 Currently available Rx treatment options often used off-label and have significant limitations7 in U.S. affected by AGA hair loss8 19-22MM people in U.S.2,3 No FDA-approved medication to repigment the skin6 16+MM people in U.S.9 RHOFADE (oxymetazoline hydrochloride) cream, 1% FDA-approved for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults, a symptom experienced in about 71% of patients with rosacea9 ROSACEA 5 Copyright 2019 Aclaris Therapeutics, Inc.
Last accessed March 30, 2019. 7National Alopecia Areata Foundation. https://www.naaf.org/alopecia-areata. Last accessed March 30, 2019.8National Institute of Health Androgenetic Alopecia. https://ghr.nlm.nih.gov/condition/androgenetic-alopecia#statistics. Last accessed March 30, 2019. 9National Rosacea Society, https://www.rosacea.org/rosacea-review/2010/summer/new-survey-uncovers-wide- range-of-potential-signs-and-symptoms.
JAMA Dermatology. 2016;152(9):1025-1033.4Kwok et al. Topical treatments for cutaneous warts (Review). Cochrane Database of Systematic Reviews.2012. Art. No.: CD001781. 5Fitzpatrick T, et al. http://www.avrf.org/facts/frequently-asked-questions.html. Last accessed March 30, 2019.6https://www.asdreports.com/news-217/vitiligo-therapeutics-market-expected-show-moderate- growth-up-2019.
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 2019 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.
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, 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, 2018, 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 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, and the growth opportunity for ESKATA and RHOFADE. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.