Novamab Announces Successful Completion of Phase IIa Clinical Trial for LQ036, the World’s First Inhaled IL-4Rα Nanobody, Demonstrating Robust Efficacy and Favorable Safety in Moderate-to-Severe Asthma
Novamab
Nanobody Innovative Drug Developer
Shanghai, China,March 25, 2025 — Novamab, a biotechnology company dedicated to the research and development of innovative nanobody drugs, announced its core inhalation product LQ036 (targeting IL-4Rα Single-Domain Antibody) Successfully Completes Phase IIa Proof-of-Concept (Proof-of-Concept, POC) Clinical research. The results indicate that,LQ036ShowcasedRapid, significant, and sustainedAnti-inflammatoryEfficacy，And has good safety and tolerability, the results are encouraging,ForTo be launchedPhase IIb Clinical Trial and Further Development Laid a Solid Foundation.
AboutLQ036 Phase IIa Clinical Study
ThisIIPhase A study is a 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the pharmacodynamic effects, safety, and immunogenicity of LQ036 in patients with moderate to severe asthma, as well as to preliminarily explore its clinical efficacy.
The study was led by Professor Su Nan from China-Japan Friendship Hospital, across ChinaA total of 19 adult patients with moderate to severe asthma were enrolled across 14 clinical centers. They were randomly assigned to receive either LQ036 or placebo via nebulized inhalation once daily for 4 weeks.
Main Outcomes of the Study
Research data shows,LQ036 PresentationOutFastRapid, significant, and sustained anti-inflammatory effects。During the inhalation treatment on Day2 days, core pharmacodynamic index exhaled nitric oxide (FeNO)）That is, a downward trend was shown. Treatment continued until the14Day,LQ036GroupFeNOThe decline reached40%, and it has significant statistical significance compared to the placebo group (p=0.007). This inhibitory effect persists until4At the end of the weekly treatment, recovery was slow after discontinuation, suggestingLQ036Compared with existing injectable biologics, it has the potential advantage of rapid onset.
In addition,LQ036 preliminarily in lung function (FEV1, FVCAndPEF) and asthma symptom index improvementPresentationOutPositiveTrend, for subsequentIIPhase B clinical research provides a reliable basis. Meanwhile,This study further validatedThe Safety of LQ036,The subjects all showed good safety and tolerability, and the immunogenicity test results were0%. This data is consistent with previous multipleData from healthy subjects in Phase I studies are consistent.
Professor Su Nan
The principal investigator of this clinical trial is from the Department of Pulmonary and Critical Care Medicine (PCCM) at China-Japan Friendship Hospital.
ThisThe main objective of the Phase IIa study is to validate LQ036Efficacy in asthma patients, the results not only showThe excellent anti-inflammatory effect of LQ036, along with the observed trend of improvement in clinical outcome indicators, is encouraging. Combined with LQ036The method of nebulized inhalation delivery leads us, the researchers, to believe that if this product is successfully launched in the near future, it has the potential to change existing treatment protocols. It could shift the biologic treatment strategy to an earlier stage of asthma patients' condition progression, avoiding or delaying disease advancement, thereby reducing patients' corticosteroid usage and alleviating the burden of their illness, as well as the economic and societal burdens.
Dr. Yakun Wan
Founder, Chairman and CEO of Novamab
LQ036 asThe World's First TargetedThe inhaled nanobody drug targeting IL-4Rα is expected to break through the limitations of current biologic treatments for respiratory diseases, filling the gap in this field. The success of this Phase IIa proof-of-concept clinical study further validates the significant clinical efficacy potential of LQ036, as well as its consistent safety, strengthening our commitment to rapidly advancing the program.IPhase B Clinical Research Confidence.We look forward toLQ036 inAbout toin clinical trials continue to achieve breakthroughs, bringing better treatment options to asthma patients worldwide as soon as possible.
About LQ036 Product
LQ036 is an inhaled nanobody drug independently developed by Novamab, with proprietary intellectual property rights. It targets IL-4Rα and is used for the treatment of asthma and COPD. LQ036 can effectively inhibit the binding of IL-4Rα to IL-4 and IL-13, thereby blocking the signaling pathway to regulate immune function, including inhibiting Th2 cell differentiation, alleviating respiratory allergic reactions, and reducing IgE synthesis, which improves asthma symptoms. Previously completed Phase I clinical studies in Australia and China have shown that LQ036 has good safety and tolerability.
About Asthma
So far, asthma remains a globally recognized medical challenge. It has been listed by the World Health Organization as one of the four most stubborn diseases, and is the second leading cause of death and disability worldwide, only after cancer. Globally, there are approximately350 million people suffer from asthma, of which approximately 5%-10% of asthma patients still cannot effectively control their symptoms after treatment with small-molecule drug inhalation.[1], there is a huge unmet clinical need. According toGINA guidelines recommend that antibody-based drugs are suitable for severe patients as add-on control therapy, serving as an additional control medication to the existing treatment regimen, and require long-term use.[2]. Then, due to the large molecular weight of monoclonal antibodies (approximately150 kDa), poor stability, and other reasons, existing technologies cannot meet the requirements for inhalation delivery of macromolecules, which can only be administered via intravenous or subcutaneous routes for treatment.
Compared with systemic administration via intravenous or subcutaneous injection, inhalation administration offers advantages such as better compliance, rapid onset, lower dosage, reduced systemic exposure, and fewer potential adverse events, making it suitable for a broader range of asthma patients.[2]。However, so far, no inhaled macromolecule asthma drugs have been approved for marketing.
About Novamab
Shanghai Novamab Biopharmaceuticals Co., Ltd. is an innovative biopharmaceutical company dedicated to the research, development, and industrialization of nanobody drugs. The company was founded in...In October 2017, located in Shanghai International Medical Park, a full-process platform covering R&D, CMC, and pilot production has been established.And establish the first in China500L Pichia pastoris nanobody GMP pilot production workshop, is currently the only company in China with the full-process development capability for nanobodies.
DeadlineIn March 2025, Novamab has applied for more than 80 domestic and international invention patents and obtained authorization.31Items. The pipeline covers areas such as respiratory, autoimmune, ophthalmology, and oncology, and has obtainedFour clinical trial approvals. Among them, the research products LQ036 and LQ043H are both globally pioneering inhaled nanobody drugs targeting the same site, with the potential to revolutionize current treatment models for respiratory diseases.
For more information, please visitwww.novamab.com。
References
[1] O'Byrne PM, Panettieri RA Jr, Taube C, Brindicci C, et al. Development of an inhaled anti-TSLP therapy for asthma. Pulm Pharmacol Ther. 2023 Feb;78:102184.
[2] Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2023. Updated May 2023.（ Available from: www.ginasthma.org.）
