LQ036 / Novamab Biopharma - LARVOL DELTA

Inhaled Anti-IL-4rα Single-domain Antibody Significantly Reduces FeNO in Moderate-to-Severe Asthma Patients: A Phase 2a Proof-of-Concept Study (ATS 2025) - "LQ036 significantly improved the airway inflammation in asthma, as evidenced by a marked inhibition in FeNO. This improvement occurred with a rapid onset as early as Day7 and was sustained throughout at least one month of treatment and two weeks after discontinuation. LQ036 was well tolerated without SAEs or incidence of ADA."

Clinical • Late-breaking abstract • P2a data • Asthma • Immunology • Inflammation • Respiratory Diseases

Luoqi Biopharmaceuticals will present the Phase IIa clinical trial data of LQ036 at the ATS 2025 conference (bydrug.pharmcube.com) - "Shanghai Lochi Biopharmaceutical Technology...announced today that Lochi Bio will be invited to attend the Respiratory Innovation Summit (RIS) and ATS International Conference hosted by the American Thoracic Society (ATS) in San Francisco, California, USA from May 16 to 21 local time. At that time, Lochi Bio will present the latest clinical data in the form of posters at the RIS and ATS conferences respectively - the first Phase IIa proof-of-concept clinical trial data of LQ036, an inhaled biologic targeting IL-4Rα developed by the company. This presentation will fully disclose the safety, tolerability, efficacy indicators and preliminary efficacy of LQ036 in patients with moderate to severe asthma, marking a key milestone for Lochi Bio in the development of next-generation respiratory inhaled biologics."

P2a data • Asthma

A Novel Inhalable Nanobody Targeting IL-4Rα for the Treatment of Asthma. (PubMed, J Allergy Clin Immunol) - "These findings from preclinical studies establish the safety and efficacy of inhaled LQ036, underscoring its potential as a pioneering inhalable biologic therapy for asthma."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • STAT6

Breaking News: Latest Update on LQ036 - The First-in-Class Inhaled IL-4Rα Single Domain Antibody (ATS 2024) - "The interim report of toxicology GLP study showed no LQ036-related toxic. All doses of LQ036 exhibited favorable safety profiles in healthy adults. LQ036 demonstrated rapid and sustained inhibition of pSTAT6 in T cells."

Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Hematological Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • IL4 • STAT6

Phase I Safety and Efficacy Evaluation of the First-in-class Inhalable Anti-IL-4Rα Single Domain Antibody (ATS 2023) - P1 | "Human IL-4 together with serial diluted Dupilumab or LQ036 were added to the whole blood from asthmatic patients. LQ036 is a homogenous bivalent single domain antibody (sdAb), which displayed good safety and efficacy during Phase I trial investigation when administrated by daily oral inhalation."

Clinical • Late-breaking abstract • P1 data • Asthma • Immunology • Respiratory Diseases • IL13 • IL4 • STAT6

First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 (clinicaltrials.gov) - P1 | N=40 | Terminated | Sponsor: Syneos Health | N=118 ➔ 40 | Enrolling by invitation ➔ Terminated; Copmeletion of Part A SAD cohorts, sponsor cancelled Part B-D cohorts

Enrollment change • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases