lofacimig (KN060) / Alphamab - LARVOL DELTA

Safety, tolerability, pharmacokinetics, and pharmacodynamics of KN060, a humanized anti-FXI/FXIa dual-domain antibody, following single ascending doses in healthy Chinese subjects. (PubMed, Res Pract Thromb Haemost) - P1 | "Based on pharmacokinetic and pharmacodynamic data, KN060 is a promising humanized dual-domain antibody simultaneously targeting FXI/FXIa for the prevention of thromboembolic diseases. https://www.chictr.org.cn, identifier: ChiCTR2200056926; http://www.chinadrugtrials.org.cn, identifier: CTR20222339."

Clinical • Journal • PK/PD data • Cardiovascular

To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Suzhou Alphamab Co., Ltd.

New P1/2 trial • Chronic Kidney Disease • Nephrology • Renal Disease

To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Suzhou Alphamab Co., Ltd.

New P1 trial • Cardiovascular • Hypertension

KN060-a humanized dual-domain antibody simultaneously targeting FXI-A2/A3 epitopes: Pioneering the Anti-Coagulation Factor XI Strategy for Aterial Hypertension - Evidence from Preclinical Models. (PubMed, Eur J Pharmacol) - "Notably, co-administration of KN060 (3 mg/kg) with losartan (5 mg/kg) in SHRs demonstrated synergistic efficacy, achieving greater SBP reduction than losartan monotherapy (ΔSBP: -23.7 mmHg vs -15.9mmHg). Its unique bispecific architecture enables near-complete FXI activity inhibition while preserving hemostatic capacity, addressing critical limitations of conventional RAAS blockers in resistant hypertension. With an ongoing Phase Ib trial in primary hypertension patients (NMPA approval No CXSL2400827), KN060 emerges as a transformative candidate for precision management of hypertension."

Journal • Preclinical • Cardiovascular • Hematological Disorders • Hypertension • Inflammation • Venous Thromboembolism

Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (clinicaltrials.gov) - P2 | N=241 | Active, not recruiting | Sponsor: Suzhou Alphamab Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Alphamab Oncology KN060 was approved for clinical study of essential hypertension [Google translation] (bydrug.pharmcube.com) - "Suzhou Alphamab Oncology Biotechnology Co., Ltd....announced that the company has independently developed a recombinant humanization FXI Single-domain Antibody Fcfusion Protein Injection (R&D code: KN060) was approved by the National Medical Products Administration (NMPA) to conduct clinical trials for essential hypertension...This Phase Ib clinical study is a randomized, Single-blind, placebo-controlled exploratory clinical trial. In this study, Professor Wang Jiguang from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, served as the principal investigator, and 60 subjects were planned to be enrolled."

New P1 trial • Hypertension