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JAK Inhibitors for Chronic Itch: What’S the Future?

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JAK Inhibitors for Chronic Itch: What’S the Future? JAK Inhibitors for Chronic Itch: What’s the Future? Brian S. Kim, MD, MTR, FAAD Twitter: @itchdoctor Associate Professor of Medicine, Anesthesiology, and Pathology and Immunology Co-Director, Center for the Study of Itch Disclosures • Consultant – AbbVie, Incyte, Menlo, Pfizer • Advisory Board – Cara, Kiniksa, Menlo • Stockholder – Locus Biosciences • Founder and Chief Scientific Officer – Nuogen Pharma, Inc. • Patents – Patent pending for JAK inhibitors in chronic itch What is chronic pruritus or itch? Itch 1. an uncomfortable sensation on the skin that causes a desire to scratch Chronic itch 1. itch that lasts for longer than six weeks The problem and unmet need 1. Chronic itch affects >15% of the population 2. Negative impact on quality of life comparable to chronic pain 3. Incidence is increasing 4. No FDA-approved medications Itch may be the most common medical symptom • Dermatologic • Medication-induced – Atopic dermatitis (AD), – Opioids, checkpoint contact dermatitis, lichen inhibitors planus, prurigo nodularis, • Neurologic psoriasis – Shingles, disc herniation, • Infection multiple sclerosis – HIV, mites/parasites • Systemic • Malignancy – Thyroid, kidney, and liver – Polycytemia vera, leukemia, disease lymphoma • Idiopathic – Chronic pruritus of 5 unknown origin (CPUO) The opportunity in chronic itch 1. Accessible population of 19 million in U.S. 2. $5.4 billion market in U.S. 3. Large population of discouraged patients 4. Recent discovery of itch-specific pathways IMS Health JAK inhibitors are rapidly emerging for the treatment of atopic dermatitis The immunologic paradigm of JAK-STAT signaling JAK Inflamed skin STAT Cytokines Companies boldly entering the itch therapeutic space Itch-sensory neurons employ JAKs The sensory paradigm of JAK-STAT signaling Immune Cell Sensory Neuron JAK STAT JAK STAT TRP Channel PRESSROOM (/ ) (http://www.abbvie.com/) SEPTEMBER 7, 2017 AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis (https://news.abbvie.com/user_pref.cfm) (/article_print.cfm? article_id=11530) - Study Oralshows positiveJAK resultsinhibitors for upadacitinib have and itch no -newselective safety signals effects detected[1] - All doses achieved the primary endpoint of greater mean percentage change from baseline in Eczema Area and Severity IndexPRESSR (EASI)OOM (/ ) score versus placebo at 16 weeks[1] (http://www.abbvie.com/) - Clear or almost clear skin was achievedSEPTEMBER by 7, 201750 percent of patients receiving 30 mg AbbVie's Upadacitinib (ABT-494) Meets Primary once-daily dose of upadacitinib[1]Endpoint in Phase 2b Study in Atopic Dermatitis - Upadacitinib demonstrated reduction in (https://news.abbvie.com/user_pref.cfm) pruritus (itch) (/article_print.cfm? within the first week and article_id=11530) improvement in skin within the first two weeks for all doses[1] - Study shows positive results for upadacitinib and no new safety signals detected[1] - Upadacitinib, an oral agent engineered- All doses achieved the primary endpoint by of greaterAbbV mean percentageie changeto fromselectively inhibit JAK1, is baseline in Eczema Area and Severity Index (EASI) score versus placebo at 16 weeks[1] - Clear or almost clear skin was achieved by 50 percent of patients receiving 30 mg once-daily dose of upadacitinib[1] being studied as a once-a-day- Upadacitinib therapy demonstrated reductionin inatopic pruritus (itch) within dermatitis the first week and and across multiple improvement in skin within the first two weeks for all doses[1] - Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-a-day therapy in atopic dermatitis and across multiple immune-mediated diseases[2],[3],[4-9]immune-mediated diseases[2],[3],[4-9] NORTH CHICAGO, Ill., Sept. 7, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 2b randomized, placebo-controlled, dose-ranging study of upadacitinib (ABT-494), an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable.1 In this study, all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percent change in EASI at week 16 versus placebo).1 Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established. "We are excited by the results of this study, which show that upadacitinib has the potential to be an important treatment option for patients with atopic dermatitis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to NORTH CHICAGO, Ill., Sept. 7, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 2b randomized, placebo-controlled, dose-ranging study of upadacitinib (ABT-494), an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable.1 In this study, all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percent change in EASI at week 16 versus placebo).1 Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established. "We are excited by the results of this study, which show that upadacitinib has the potential to be an important treatment option for patients with atopic dermatitis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to Oral JAK inhibitors have itch-selective effects Figure 6 Chronic Pruritus of Chronic Pruritus of Unknown Origin (CPUO) A B Atopic Dermatitis Unknown Origin (CPUO) Tofacitinib ** Cyclosporine Tofacitinib 10 10 e e r 8 r 8 o o c c S S 6 6 h h c c t t I I 4 4 S S R R 2 N 2 N 0 0 0 10 20 30 40 50 60 70 Day Oetjen et al. Cell 2017 Topical JAK inhibitors demonstrate anti-itch effects by 24-36 hours A Phase 2, Randomized, Dose-Ranging, Vehicle- and Active-Controlled Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Adult Patients With Atopic Dermatitis Brian S. Kim, MD, MTR,1 Adnan Nasir, MD, PhD,2 Kim Papp, MD, PhD3 Lawrence C. Parish, MD,4 Michael E. Kuligowski, MD, PhD, MBA,5 May Venturanza, MD,5 Kang Sun, PhD,5 Joseph F. Fowler, MD6 1Washington University, St. Louis, MO, USA; 2Wake Research Associates LLC, Raleigh, NC, USA; 3K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada; 4Paddington Testing Co., Inc, Philadelphia, PA, USA; 5Incyte Corporation, Wilmington, DE, USA; 6DS Research, Louisville, KY, USA EADV Paris 2019 The intranasal route can directly access the cerebrospinal fluid Djupesland et al. Therapeutic Delivery 2014 Intranasal JAK inhibition suppresses itch JAK1-selective Inhibitors: PF – PF-04965842 * INCB – itacitinib 250 * WT Behavior Low Dose JAKi (i.n.) & Sac. 125 Day 0 1 2 3 4 5 6 7 0 AD-like disease Scratching bouts / 30 min / 30 bouts Scratching *P value = 0.0417 Ordinary one-way ANOVA Unpublished Data Chronic itch beyond atopic dermatitis Chronic Pruritus of Unknown Origin Neuropathic Pruritus Idiopathic Brachioradial pruritus Elderly pruritus Notalgia paresthetica Scalp pruritus Genital pruritus Medication-Associated Pruritus Opioids Checkpoint inhibitors Systemic Pruritus Chronic kidney disease Malignancy-Associated Pruritus Hepatobiliary disease Leukemia/lymphoma Polycythemia vera Acknowledgements (Academic) Kim Lab Funding Nancy Bodet (Research Nurse) K08AR065577-03 Madison Mack (PhD Student) R01AR070116-01 Stephanie Morrison Doris Duke Charitable Foundation Landon Kyle Oetjen (MD/PhD Student) LEO Pharma Research Grant Anna Trier (MD/PhD Student) Fang Wang (Postdoctoral Fellow) Collaborators Qin Liu Robert Gereau Hongzhen Hu Chyi-Song Hsieh Zhoufeng Chen Steve Davidson (U Cinn) Mark Miller Acknowledgements (Nuogen Pharma) Duke Leahey, MA Jonathan Hull, PhD Michael Leahey, MS Patty Walker, MD/PhD Xinzhong Dong, MD/PhD Launch CEO COO CFO Advisor Advisor and President VP of Bioelectronica Former President and Professor of Neuroscience CSO Brickell Therapeutics Johns Hopkins School Of Medicine HHMI Investigator Founder of Escient Pharmaceuticals Andy Hoyne, General Counsel Kent Fedde, PhD, Patent Counsel Judy Ballard, STTR/SBIR Coordinator and Accounting Support Acknowledgements.
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