AQ280 / LEO Pharma, Aqilion - LARVOL DELTA

CLINICAL DEVELOPMENT OF AQ280, A POTENT AND HIGHLY SELECTIVE JAK1 INHIBITOR, FOR THE TREATMENT OF EOSINOPHILIC ESOPHAGITIS (DDW 2024) - "Dupilumab that targets IL-4 and IL-13 has shown efficacy in EoE which lends support to the notion that inhibiting the Th immune response will have clinical utility in EoE. AQ 80 is a potent and highly selective JAK1 inhibitor which can inhibit EoE relevant Th inflammation pre-clinically. It has been shown to be safe and to inhibit"

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Pain • CCL11 • CXCL10 • IL13 • IL15 • IL33 • IL4 • IL5 • IL9 • TSLP

Aqilion has completed Phase 1 study with AQ280 within the Regulus program (PharmiWeb) - "AQILION (publ) announces today that it has successfully completed the first clinical study in humans within the Regulus program. The Phase 1 ARIA-1 study was conducted to evaluate the safety, tolerability, and pharmacokinetics of the drug candidate AQ280 in healthy adult participants, given in single dose and repeated dosing. The preliminary study results are expected in Q4 2023....The preliminary study results, focusing on pharmacokinetics and tolerability, will be presented in Q4, 2023."

P1 data • Trial completion • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology

SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: AQILION AB | Recruiting ➔ Completed

Trial completion • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: AQILION AB | Trial completion date: Jan 2023 ➔ Apr 2023 | Trial primary completion date: Jan 2023 ➔ Apr 2023

Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Aqilion starts Phase 1 clinical trial with drug candidate AQ280 for chronic inflammatory diseases (Cision) - "AQILION AB...announces today that the Phase 1 clinical safety study on the drug candidate AQ280 on healthy volunteers has started....The Phase 1 clinical trial, ARIA-1, will include 64 healthy volunteers. The purpose of the study is to investigate possible side effects and pharmacokinetics....ARIA-1 is being conducted as a dose escalation study, which means that the trial begins with a very low dose, after which the dose is gradually increased. The primary aim of the study is to determine the tolerability and safety of AQ280, which will be evaluated in steps in one group with an escalating single dose (single ascending dose, SAD) and in another group with a repeated oral dosage over several days (multiple ascending dose, MAD). The clinical trial is being conducted in the UK with the approval of the British Medicines and Healthcare Products Regulatory Agency (MHRA). The results from the Phase 1 clinical trial are expected in the mid-2023."

Trial status • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology

SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: AQILION AB

New P1 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology