ATI-2138 / Aclaris - LARVOL DELTA

Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: Aclaris Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of ATI-2138 in Adult Participants with Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=14 | Active, not recruiting | Sponsor: Aclaris Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders:..Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs. Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025...Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor...Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025..."

IND • New P2b trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Pulmonary Disease • Ulcerative Colitis

Characterization of the dual ITK/JAK3 small molecule covalent inhibitor ATI-2138. (PubMed, J Pharmacol Exp Ther) - "ATI-2138 inhibits JAK3 and ITK in enzyme and functional cellular assays, demonstrates disease-modifying activity in rodent models of arthritis and colitis, and inhibits biomarkers linked to both ITK and JAK3 activity in healthy human participants. With this dual kinase activity against components of these inflammatory signaling pathway, ATI-2138 has the potential for enhanced therapeutic efficacy in the treatment of autoimmune and chronic inflammatory disease."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Rheumatology • IL2 • ITK • JAK3

New Publication Highlights Unique Properties of ATI-2138, a Potent and Selective Inhibitor of ITK and JAK3 (GlobeNewswire) - "ATI-2138 covalently inhibits ITK...more potently than the other Tec kinase family members and is selective for JAK3 inhibition relative to the other JAK isoforms...ATI-2138 dose-dependently decreased JAK1/JAK3-dependent IL-2-stimulated STAT5 phosphorylation in human peripheral blood mononuclear cells (PBMCs) with low-nanomolar potency...The functional cellular data demonstrating the impact of ATI-2138 on ITK and JAK3 biology translated into efficacy in multiple rodent models of chronic inflammation...In healthy human participants, ATI-2138 was generally well tolerated at all doses tested in both the SAD and MAD trials."

Clinical data • Preclinical • Immunology • Inflammation

Aclaris Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor for the Treatment of Moderate to Severe Atopic Dermatitis (GlobeNewswire) - "Aclaris Therapeutics...today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the treatment of moderate to severe atopic dermatitis (AD)....Aclaris expects topline data from this trial in the first half of 2025."

P2a data • Trial status • Atopic Dermatitis

Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Aclaris Therapeutics, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update (GlobeNewswire) - "R&D expenses were $98.4 million for the year ended December 31, 2023 compared to $77.8 million for the prior year period....ATI-2138 development expenses, including costs associated with the Phase 1 MAD trial and other preclinical activities..."

Commercial • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update (Yahoo Finance) - "ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor:...Based on analysis of the PK, PD and safety, Aclaris is progressing ATI-2138 into Phase 2a clinical development in ulcerative colitis, which it expects to initiate in early 2024....Research and development (R&D) expenses were $23.9 million for the quarter ended September 30, 2023 compared to $23.7 million for the prior year period. The $0.2 million increase was primarily the result of: An increase in ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities..."

Commercial • New P2a trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Aclaris Therapeutics Announces Positive Results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor (GlobeNewswire) - P1 | N=60 | "Aclaris Therapeutics, Inc...today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138. Preliminary data from the MAD trial demonstrated: that ATI-2138 was generally well tolerated at all doses tested in the trial; that ATI-2138 had dose proportional pharmacokinetics (PK); and a dose-dependent inhibition of both ITK and JAK3 exploratory pharmacodynamic (PD) biomarkers, with near maximal inhibition achieved at the 30 mg total daily dose. Based on these results, Aclaris will progress this program into a Phase 2a proof of concept study in patients with ulcerative colitis, its previously announced intended first clinical development target, and anticipates initiation of the trial in early 2024."

New P2a trial • P1 data • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Aclaris Therapeutics Reports Second Quarter 2023 Financial Results and Provides a Corporate Update (Yahoo Finance) - "Healthy Volunteers (ATI-2138-PKPD-102): This two-week Phase 1 MAD (multiple ascending dose) trial to investigate the safety, tolerability, PK and PD of ATI-2138 in healthy volunteers has been completed....Aclaris expects to report the data in September 2023....Research and development (R&D) expenses were $25.3 million for the quarter ended June 30, 2023 compared to $18.8 million for the prior year period....ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities."

Commercial • P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Dr. Vince Clinical Research Announces Dosing of Aclaris Therapeutics’ Phase I MAD Study of ATI-2138 (Businesswire) - “Dr. Vince Clinical Research (DVCR)…announced that it has administered the first dose of Aclaris Therapeutics’ ATI-2138 in a Phase I multiple ascending dose (MAD) study for an investigational oral compound being developed for the treatment of autoimmune diseases. The Phase I MAD study in healthy volunteers is being conducted at DVCR’s world-class clinical pharmacology unit. The study will enroll 60 participants across five cohorts.”

Trial status • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Successfully Completed ATI-2138 Phase 1 SAD (single ascending dose) Trial in November; Selected Ulcerative Colitis as First Clinical Development Target...Aclaris submitted a new IND for this program to the U.S. Food and Drug Administration’s (FDA) Gastroenterology Division in October 2022 for the treatment of ulcerative colitis. If allowed, Aclaris intends to initiate a Phase 1 MAD trial of ATI-2138 in healthy subjects by the end of 2022."

IND • New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Aclaris Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - “Research and Development Highlights: Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics…of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing. Aclaris continues to expect topline data in 2023….Psoriatic Arthritis (ATI-450-PsA-201): Aclaris initiated study activities in the second quarter in this Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib…Aclaris continues to expect topline data in the first half of 2023; ATI-2138: If the Phase 1 SAD trial is successful, Aclaris currently plans to initiate a Phase 1 multiple ascending dose (MAD) trial of ATI-2138 in subjects with psoriasis in 2022.”

New P1 trial • P2 data • Immunology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris Therapeutics, Inc...today announced its financial results for the fourth quarter and full year of 2021 and provided a corporate update....Aclaris plans to progress ATI-1777 into a Phase 2b trial in subjects with moderate to severe AD in the first half of 2022. In this trial, Aclaris plans to explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777, in patients 12 years and older....ATI-2138-PKPD-101: This Phase 1 single ascending dose (SAD) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-2138 in healthy subjects is ongoing. Aclaris expects topline data in 2022."

New P2b trial • P1 data • Atopic Dermatitis • Immunology • Psoriasis

Aclaris Therapeutics to Host Virtual R&D Day on December 7, 2021 (GlobeNewswire) - "Aclaris Therapeutics, Inc...announced that it will host a virtual R&D Day on Tuesday, December 7, 2021 from 10:00 a.m. to 12:00 p.m. ET. 'We are pleased to announce that the IND application for ATI-2138, an investigational oral small molecule ITK/TXK/JAK3 (ITJ) inhibitor, for the treatment of psoriasis has been allowed by the U.S. Food and Drug Administration and we are very excited about our plans to progress this third novel compound from our proprietary KINect® drug discovery platform into clinical development...'"

IND • Immunology • Psoriasis

Aclaris Therapeutics Reports Third Quarter 2021 Financial Results and Provides a Corporate Update (Yahoo Finance) - "Aclaris submitted an Investigational New Drug Application (IND) for ATI-2138 for the treatment of psoriasis in October 2021 and, if allowed, Aclaris plans to progress to a first-in-human Phase 1 single ascending dose trial of ATI-2138 in healthy volunteers...R&D expenses were $29.7 million for the nine months ended September 30, 2021 compared to $20.4 million for the prior year period...Continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline also contributed to the increase as Aclaris progressed towards an IND submission for ATI-2138."

Commercial • New P1 trial • Immunology • Psoriasis

Aclaris Therapeutics Reports Second Quarter 2021 Financial Results and Provides a Corporate Update (Yahoo Finance) - "Preclinical Asset; ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound: Currently being developed as a potential treatment for psoriasis and/or inflammatory bowel disease. Submission of Investigational New Drug Application (IND) is expected in the second half of 2021...Research and development (R&D) expenses were $7.9 million for the quarter ended June 30, 2021 compared to $6.5 million for the prior year period. The quarter-over-quarter increase of $1.4 million was primarily the result of continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline, including ATI-450 and ATI-2138..."

Commercial • IND • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update (GlobeNewswire) - "ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound: Aclaris is developing ATI-2138...for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease and expects to submit an Investigational New Drug Application for ATI-2138 in the second half of 2021."

IND • Immunology • Inflammatory Bowel Disease • Psoriasis

Aclaris Therapeutics Reports Third Quarter 2020 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an Investigational New Drug (IND) Application for ATI-2138 in 2021."

IND • Immunology • Inflammatory Bowel Disease • Psoriasis

Aclaris Therapeutics reports first quarter 2020 financial results and provides R&D and business highlights (GlobeNewswire) - "ATI-450-RA-201: Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment of subjects in the trial....Aclaris previously anticipated reporting data from this trial in the second half of 2020; however, Aclaris expects that the data may be delayed and will provide an update, at a later date....Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020. If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis....ATI-2138: ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease. Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021."

IND • P2 data • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Rheumatoid Arthritis • Rheumatology