ICP-332 / InnoCare - LARVOL DELTA

ICP-332 in Subjects with Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=552 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China (Businesswire) - "ICP-332 is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders...with broad market prospects."

Trial status • Atopic Dermatitis

Recent progress in tyrosine kinase 2 inhibitors for atopic dermatitis. (PubMed, Expert Opin Investig Drugs) - "We also provide a detailed assessment of ICP-332 efficacy, safety, and potential adverse effects in moderate-to-severe AD. Janus kinase inhibitors that have been recently approved have shown promise for the treatment of AD, especially for patients with severe phenotypes. Preliminary findings from randomized controlled trials suggest that TYK2 inhibitors exhibit rapid efficacy and acceptable safety in the management of AD; however, additional investigations, including long-term trials, are warranted to fully understand their efficacy and safety profile."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TYK2

Phase I Study of ICP-332 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: InnoCare Pharma Inc.

New P1 trial

InnoCare Announces First Subject Dosed in Clinical Trial of TYK2 Inhibitor ICP-332 in the U.S. (Businesswire) - "InnoCare Pharma...announced that the first subject has been dosed in clinical trial of the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-332 in the United States."

Trial status • Atopic Dermatitis

InnoCare Announces Clearance of Clinical Trial of TYK2 Inhibitor ICP-332 by U.S. FDA (Businesswire) - "InnoCare Pharma...announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332."

IND • Atopic Dermatitis • Immunology

Efficacy and Safety of a Highly Selective Oral TYK2/JAK1 Inhibitor, ICP-332, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II, Randomized, Placebo-Controlled Trial (AAD 2024) - No abstract available

Clinical • Late-breaking abstract • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • TYK2

InnoCare Announces Phase II Study Results of TYK2 Inhibitor ICP-332 Meet Primary Endpoint in Patients with Atomic Dermatitis (Businesswire) - P2 | N=75 | NCT05702268 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "InnoCare Pharma...announced today that phase II clinical study results of...ICP-332 met primary endpoint in adult patients with moderate-to-severe atopic dermatitis (AD)....ICP-332 achieved multiple efficacy endpoints including Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90...and Investigator’s Global Assessment (IGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in 80mg and/or 120mg dosing groups respectively. The mean percentage change from baseline in the EASI score reached 78.2% and 72.5% at once-daily dosing group of 80mg and 120mg respectively, both with a highly significant P value (p<0.0001), compared to 16.7% for patients receiving placebo. EASI 75 reached 64% and 64% at 80 mg and 120 mg dosing group respectively, compared to 8% percent for patients receiving placebo (p<0.0001)."

P2 data • Atopic Dermatitis • Immunology

InnoCare Releases 2023 Interim Results and Business Highlights (Businesswire) - P1 | N=72 | NCT05399030 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "Phase I data demonstrated a dose proportional and favorable PK profile, no observation of significant food effect, and well tolerated and good safety profile. InnoCare initiated a Phase II study of ICP-332 in atopic dermatitis (AD) with a data readout expected by the end of 2023."

P1 data • P2 data • Atopic Dermatitis • Immunology

Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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

InnoCare Releases 2022 Mid-Year Results and Business Highlights (Businesswire) - "InnoCare Pharma...today announced 2022 mid-year results which ended on June 30, 2022....Phase II clinical trial of orelabrutinib for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in China was initiated. ICP-332: Phase I clinical trial of the novel tyrosine kinas 2 (TYK2) inhibitor was completed, showing a positive safety profile. Phase II trials for the treatment of atopic dermatitis (AD) and psoriasis were initiated."

Trial status • Atopic Dermatitis • Immunology • Neuromyelitis Optica Spectrum Disorder • Psoriasis

A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Feb 2022 | Trial primary completion date: Jun 2022 ➔ Jan 2022

Trial completion • Trial completion date • Trial primary completion date

A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P1 trial

InnoCare Releases 2021 Annual Results and Business Highlights (PRNewswire) - P1 | N=NA | "InnoCare Pharma...today announced 2021 annual results as of 31 December 2021....The Phase I clinical trial of the novel tyrosine kinas 2 (TYK2) inhibitor was completed. ICP-332 demonstrated dose proportionality of the PK parameters in the range of 5 mg to 320 mg. No significant food effect was observed. ICP-332 was safe and well tolerated and the maximum tolerated dose was not reached. ICP-332 also avoided certain adverse effects associated with non-selective JAK inhibitors."

P1 data • Atopic Dermatitis • Immunology • Psoriasis

InnoCare Announces First Subject Dosed in Clinical Trial of ICP-332 (PRNewswire) - "InnoCare...announced today the first subject dosed in clinical trial of novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-332 in China. ICP-332 will be used to treat psoriasis and other T cell related autoimmune diseases."

Trial status • Atopic Dermatitis • Immunology • Psoriasis

InnoCare Announces Approval of Clinical Trial of TYK2 Inhibitor ICP-332 in China (Businesswire) - "InnoCare...announced today that China National Medical Products Administration has approved the Phase I clinical trial of InnoCare’s novel TYK2 (Tyrosine Kinase 2) inhibitor, which becomes the company’s fifth innovative drug to enter the clinical phase...ICP-332 is designed to be a potent and selective TYK2 inhibitor with 400 folds of selectivity against JAK2 to avoid the adverse events associated with non-selective JAK inhibitors. ICP-332 will be used to treat autoimmune diseases such as psoriasis and atopic dermatitis."

New P1 trial • Atopic Dermatitis • Psoriasis