SM17 / LifeArc, SinoMab - LARVOL DELTA

Breakthrough Phase 1b POC Results for SM17 in Atopic Dermatitis Potentially a First-and Best-in-Class Product, Combining Deep Pruritus Relief, Effective Skin Clearance, and a Well tolerated Safety Profile - P1b | N=32 | "SM17 Competitive Advantages: First AD biologic with dual efficacy --- first and the only AD biologic that could reach both NRS-4 1 and EASI-75 responder rate over 60%3 simultaneously at end of treatment (EOT), comparing to marketed product; Faster and deeper itch relief than anti-IL-4/13 agents --- onset of anti-pruritus effect as early as Week 2 (SM17) vs Week 4~6 (other agents), over 90% of patients achieved NRS-4 (SM17) vs 30~40% of patients (other agents) at EOT; Safer than JAK inhibitors --- No serious adverse events (SAEs) nor drug related Grade 3 or above adverse events (AEs) reported， minimum risk of serious infections or major adverse cardiovascular events (MACE)."

P1 data • Atopic Dermatitis

Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of SM17 in healthy volunteers: results from pre-clinical models and a first-in-human, randomized, double blinded clinical trial. (PubMed, Front Immunol) - P1 | "The pre-clinical efficacy and clinical PK and immunogenicity results of SM17 support further clinical development. https://clinicaltrials.gov/, identifier NCT05332834."

Clinical • Journal • P1 data • PK/PD data • Preclinical • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL17A • IL17RA • IL17RB • IL4 • IL5 • IL9

A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects (clinicaltrials.gov) - P1 | N=77 | Completed | Sponsor: SinoMab BioScience Ltd | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Lactobacillus acidophilus VB1 co-aggregates and inhibits biofilm formation of chronic otitis media-associated pathogens. (PubMed, Braz J Microbiol) - "Our data showed significant differences in the synergistic activity when La-CFS was combined with ciprofloxacin, in comparison to the use of each compound alone, against Pseudomonas aeruginosa SM17 and Proteus mirabilis SM42. The anti-biofilm activities of CFS and biosurfactant (BS) of L. acidophilus VB1 were evaluated, and we found that the minimum biofilm inhibitory concentration that inhibits 50% of bacterial biofilm (MBIC50) of La-CFS was significantly lower than MBIC50 of La-BS against the tested pathogenic bacterial species. Lactobacillus acidophilus, isolated from Vitane Vitalactic B capsules, demonstrated promising antibacterial and anti-biofilm activities against otitis media pathogens, highlighting its potential as an effective complementary/alternative therapeutic strategy to control bacterial ear infections."

Journal • Infectious Disease • Otorhinolaryngology • Pneumonia

Multidrug-resistant Stenotrophomonas maltophilia in residential aged care facilities: An emerging threat. (PubMed, Microbiologyopen) - "Alarmingly, 49.3% (36/73) of the isolates were non-wild type for colistin, with minimum inhibitory concentration values of > 4 mg/L, and 11.0% (8/73) were resistant to trimethoprim-sulfamethoxazole. Genotypic assessment of known lineages revealed isolates clustering with Sm17 and Sm18, lineages not previously reported in Australia, suggesting the potential ongoing spread of MDR S. maltophilia. Lastly, although only a few isolates were biocide tolerant (2.7%, 2/73), their ability to grow in high concentrations (64 mg/L) of triclosan is concerning, as it may be selecting for their survival and continued dissemination."

Journal • Infectious Disease

SM17, a new IL-17RB-targeting antibody, ameliorates disease progression in a mouse model of atopic dermatitis. (PubMed, Allergy) - No abstract available

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL17RB

China Antibody-B (03681): SM17 completed the administration of the first cohort of healthy subjects in China’s Phase I clinical trial [Google translation] (Investing.com) - P1 | N=NA | "China Antibody-B...announced that SM17 I will be conducted in China on November 25, 2023. In the phase 1 clinical trial, the first cohort of healthy subjects has been successfully administered. As of the date of this announcement, no adverse events (AEs) have been reported. This Phase I clinical study aims to explore the safety, pharmacokinetics (PK), and immunogenicity of SM17 in Chinese subjects, and to preliminarily verify the safety and effectiveness of SM17 in patients with atopic dermatitis. and pharmacodynamic characteristics....SM17 I ongoing in the United States The phase 1 study is nearing completion, with the last subject (LPLV) visit completed in September 2023; and a clinical summary report will be completed in the first quarter of 2024."

P1 data • Trial status • Atopic Dermatitis • Immunology

China Antibody-B (03681.HK) rose 2.5% SM17 new drug research application was approved by the State Food and Drug Administration [Google translation] (jrj.com) - "China Antibody-B...announced that on September 8, 2023, the company submitted a first-in-class (First-in- Class) therapeutic product SM17’s new drug research application has been approved by the China National Medical Products Administration. Approval of the investigational new drug application will enable the company to launch clinical research and development projects in China for the treatment of atopic dermatitis indications. The company plans to launch a Phase I clinical trial in China in the fourth quarter of this year, aiming to explore the safety of SM17 in the Chinese population and initiate the clinical development plan of SM17 for the treatment of allergic diseases."

New P1 trial • Atopic Dermatitis • Immunology

SinoMab Submits another IND Application for SM17 for the Treatment of Atopic Dermatitis, Which was Accepted by NMPA CDE (ACN Newswire) - "...SinoMab BioScience Limited...is pleased to announce that an Investigational New Drug application ('IND') for SM17, a humanised anti-IL-17RB monoclonal antibody for injection, for atopic dermatitis ('AD') , has been filed with and accepted by the Center for Drug Evaluation ('CDE') of the National Medical Products Administration of China ('NMPA'). The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of AD....The IND is mainly for the treatment of AD, and the Company will initiate a Phase I clinical study in China upon approval of the present IND."

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: SinoMab BioScience Ltd | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2023 ➔ Sep 2023

Enrollment open • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases