ATI-1777 / Aclaris, Pediatrix Therap - LARVOL DELTA

ATI-1777, a Topical Jak1/3 Inhibitor, May Benefit Atopic Dermatitis without Systemic Drug Exposure: Results from Preclinical Development and Phase 2a Randomized Control Study ATI-1777-AD-201. (PubMed, JID Innov) - P2a | "Topical ATI-1777 does not lead to pharmacologically relevant systemic drug exposure and may reduce clinical signs of atopic dermatitis. The study was registered at ClinicalTrials.gov with the number NCT04598269."

Clinical • Journal • P2a data • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Hematological Disorders • Immunology • JAK1

Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=250 | Completed | Sponsor: Aclaris Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis (GlobeNewswire) - P2 | N=250 | NCT05432596 | Sponsor: Aclaris Therapeutics, Inc. | "Aclaris Therapeutics, Inc...announced top-line results from its Phase 2b study of ATI-1777, an investigational topical 'soft' JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596)....While not statistically superior, ATI-1777 2% QD showed a trend toward significance (68.3% compared to 59.5% in vehicle, p=0.086). In the per-protocol population, or all patients who had week 4 data with no major protocol deviations, ATI-1777 2% BID demonstrated a 70.8% reduction in EASI compared to a 58.5% reduction in vehicle (p=0.025), and ATI-1777 2% QD demonstrated a 68.4% reduction in EASI compared to a 59.7% reduction in vehicle (p=0.102)."

P2b data • Atopic Dermatitis • Dermatitis • Immunology

Aclaris Therapeutics Provides Corporate Update (Yahoo Finance) - P2a | N=50 | NCT04598269 | Sponsor: Aclaris Therapeutics, Inc. | "Aclaris Therapeutics, Inc...today announced several corporate updates. First, Aclaris announced the publication of the Phase 2a trial results of ATI-1777 in moderate to severe atopic dermatitis (AD) in the peer-reviewed journal JID Innovations on November 27, 2023....The article...presents the results from both preclinical development studies and the Phase 2a study of ATI-1777 in moderate to severe AD....In the Phase 2a study, ATI-1777 demonstrated meaningful improvement in the modified Eczema Area and Severity Index (EASI) over 4 weeks of treatment and minimal measurable systemic exposure with a 2% formulation applied twice daily."

P2a data • Preclinical • Atopic Dermatitis • Immunology

Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=250 | Active, not recruiting | Sponsor: Aclaris Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Completes Enrollment in Phase 2b Study of ATI-1777 for Mild to Severe Atopic Dermatitis (ATI-1777-AD-202) (GlobeNewswire) - "Aclaris Therapeutics, Inc...today announced the completion of enrollment into ATI-1777-AD-202, its Phase 2b trial of its investigational topical 'soft' Janus kinase (JAK) 1/3 inhibitor, ATI-1777, in patients with mild to severe atopic dermatitis. Aclaris anticipates releasing top-line efficacy, safety and other preliminary data from this trial around the end of this year....'With this achievement, we are positioned for a very exciting year end for our two lead assets, first with the data read-out of our Phase 2b trial of zunsemetinib (ATI-450) in rheumatoid arthritis expected in November, followed by the top-line results of the ATI-1777 trial expected around year end.'"

Enrollment closed • P2b data • Atopic Dermatitis • Immunology • Rheumatoid Arthritis

Aclaris Therapeutics Reports First Quarter 2023 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with mild to severe AD is ongoing. In April 2023, Aclaris modified the protocol to expand the inclusion criteria for the trial to enroll patients with milder disease to broaden the drug’s target indication potential and to further aide enrollment which was challenged by an unexpected milder winter season. As a result, Aclaris currently projects topline data in the second half of 2023, rather than mid-year 2023."

Clinical protocol • P2b data • Atopic Dermatitis • Immunology

Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=240 | Recruiting | Sponsor: Aclaris Therapeutics, Inc. | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Mar 2023 ➔ Sep 2023

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Provides 2023 Outlook (GlobeNewswire) - "Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with moderate to severe AD is ongoing. Aclaris expects topline data mid-year 2023."

P2b data • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

Aclaris Therapeutics and Pediatrix Therapeutics Announce License Agreement for ATI-1777 in Greater China (GlobeNewswire) - "Aclaris Therapeutics, Inc...and Pediatrix Therapeutics, Inc...announced that the companies have entered into a license agreement. Under the license agreement, Aclaris has granted Pediatrix the exclusive rights to develop, manufacture and commercialize ATI-1777, Aclaris’ investigational 'soft' Janus kinase (JAK) 1/3 inhibitor, for any disease, including atopic dermatitis, in Greater China (Mainland China, Hong Kong, Macau and Taiwan). Aclaris will retain the rights to develop, manufacture and commercialize ATI-1777 in the rest of the world. Under the terms of the agreement, Aclaris will receive an upfront payment of $5 million. In addition, Aclaris is eligible to receive milestone payments of up to $91 million if certain development, regulatory and commercial objectives are achieved. Aclaris is also eligible to receive a tiered royalty ranging from a low-to-high single digit percentage of net sales of ATI-1777 by Pediatrix in Greater China."

Licensing / partnership • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

"$ACRS Aclaris Therapeutics and Pediatrix Therapeutics Announce License Agreement for ATI-1777 in Greater China https://t.co/NRr4s07IbQ" (@stock_titan)

Clinical • Licensing / partnership

Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris Therapeutics, Inc...announced its financial results for the third quarter of 2022 and provided a corporate update....This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of ATI-1777 in subjects with moderate to severe AD is ongoing. Aclaris continues to expect topline data in the first half of 2023."

P2 data • Atopic Dermatitis • Immunology

Aclaris Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - “Research and development (R&D) expenses were $18.8 million for the quarter ended June 30, 2022 compared to $7.9 million for the prior year period.The $10.9 million increase was primarily the result of higher: Zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA, a Phase 2a trial for HS and a Phase 2a trial for PsA. ATI-1777 development expenses related to drug candidate manufacturing and other preclinical activities and start-up costs associated with a Phase 2b clinical trial. Preclinical development activities related to ATI-2231.”

Commercial • Atopic Dermatitis • Immunology • Psoriatic Arthritis • Rheumatoid Arthritis

Study of ATI-1777 in Patients 12 to 65 Years Old With Moderate or Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=240 | Recruiting | Sponsor: Aclaris Therapeutics, Inc.

New P2b trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Reports First Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris Therapeutics, Inc...announced its financial results for the first quarter of 2022 and provided a corporate update....ATI-1777-AD-202: Aclaris activated multiple clinical sites in May 2022 in this Phase 2b trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe AD. In this trial, Aclaris will 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; Aclaris expects topline data in the first half of 2023."

P2b data • Trial status • Atopic Dermatitis • Immunology

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 Reports Third Quarter 2021 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris Therapeutics, Inc...today announced its financial results for the third quarter of 2021 and provided a corporate update....Aclaris plans to progress ATI-1777 into a Phase 2b trial in moderate to severe atopic dermatitis 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."

New P2b trial • Atopic Dermatitis • Immunology

Aclaris Therapeutics Reports Second Quarter 2021 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris plans to progress ATI-1777 into a Phase 2b trial in moderate to severe atopic dermatitis....Research and development (R&D) expenses were $7.9 million for the quarter ended June 30, 2021...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, partially offset by lower quarter-over-quarter development costs for ATI-1777....R&D expenses were $15.7 million for the six months ended June 30, 2021...The quarter-over-quarter increase of $1.6 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, partially offset by lower quarter-over-quarter development costs for ATI-1777 and compensation expenses."

Commercial • New P2b trial • Atopic Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Announces Positive Preliminary Topline Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis (GlobeNewswire) - P2, N=50; NCT04598269; Sponsor: Aclaris Therapeutics, Inc.; "Aclaris Therapeutics...today announced positive preliminary topline results...in 50 subjects with moderate to severe atopic dermatitis (AD) (ATI-1777-AD-201)....The primary efficacy endpoint of this trial was the percent change from baseline in the modified Eczema Area and Severity Index (mEASI) score at week 4. The mEASI is a modified measure of EASI which excludes evaluation of the body areas that were not treated in the trial (i.e., the head, palms of hands, soles of feet, groin, or genitalia). Only the primary efficacy endpoint was powered to detect a statistically significant outcome....Final trial results will be submitted for publication in a peer-reviewed scientific journal."

P2 data • Atopic Dermatitis • Immunology

Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis (clinicaltrials.gov) - P2a; N=50; Completed; Sponsor: Aclaris Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Reports First Quarter 2021 Financial Results and Provides a Corporate Update (GlobeNewswire) - "ATI-1777-AD-201: Data from this trial are now expected in the second quarter of 2021....Research and development (R&D) expenses were $7.8 million for the quarter ended March 31, 2021...The quarter-over-quarter increase of $0.1 million was primarily the result of continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline, including...ATI-1777..."

Commercial • P2a data • Atopic Dermatitis • Immunology

Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis (clinicaltrials.gov) - P2a; N=42; Active, not recruiting; Sponsor: Aclaris Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Completes Enrollment in its Phase 2a Clinical Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis (BioSpace) - "Aclaris Therapeutics...today announced that it has completed enrollment in its Phase 2a clinical trial of ATI-1777...for the potential treatment of moderate to severe atopic dermatitis (AD) (ATI-1777-AD-201)….Aclaris expects data from this trial by mid-year 2021."

Enrollment closed • P2a data • Atopic Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021....ATI-450-PKPD-102: A final analysis of this trial is underway....ATI-1777-AD-201: The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4. Data from this trial are expected mid-year 2021."

New P2b trial • P1 data • P2a data • Atopic Dermatitis • Immunology

Aclaris Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of ATI-1777, an Investigational Topical “Soft” JAK 1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis (BioSpace) - "Aclaris Therapeutics...today announced that the first patient has been dosed in Aclaris’ Phase 2a clinical trial of ATI-1777...for the treatment of moderate to severe atopic dermatitis (AD)....Aclaris’ planned enrollment for this trial is approximately 42 subjects and the trial will be conducted in the U.S. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4."

Trial status • Atopic Dermatitis • Dermatology