SHR-1222 / Jiangsu Hengrui Pharma - LARVOL DELTA

Biochemical Mechanisms and Rehabilitation Strategies in Osteoporosis-Related Pain: A Systematic Review. (PubMed, Clin Pract) - "Pharmacological options such as NSAIDs, opioids, and new agents like SHR-1222, along with surgical interventions like percutaneous vertebroplasty, offer additional pain reduction, especially when included in individualized rehabilitation projects; This review highlights advancements in understanding osteoporotic pain mechanisms and identifies promising treatments. Integrating targeted therapies and rehabilitation strategies can enhance patients' pain relief."

Journal • Review • Osteoporosis • Pain • Rheumatology

A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients (clinicaltrials.gov) - P1 | N=107 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jul 2022

Trial completion • Trial completion date • Osteoporosis • Rheumatology • COL1A2

Multiple doses of SHR-1222, a sclerostin monoclonal antibody, in postmenopausal women with osteoporosis: A randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial. (PubMed, Front Endocrinol (Lausanne)) - "Thus, multiple doses of SHR-1222 showed an acceptable safety profile and dose-dependent plasma exposure in women with POP, and could improve their BMD rapidly and prominently by promoting bone formation and inhibiting bone resorption. These findings further support SHR-1222 as a potential alternative agent for the treatment of POP."

Clinical • Journal • P1 data • Back Pain • Dyslipidemia • Musculoskeletal Pain • Osteoporosis • Pain • Rheumatology • COL1A2

Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: Second Xiangya Hospital of Central South University | Unknown status ➔ Completed

Trial completion • Osteoporosis • Rheumatology • CRP • EDN1 • PAI1

A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients (clinicaltrials.gov) - P1; N=107; Active, not recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Dec 2022; Trial primary completion date: Oct 2020 ➔ Aug 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Osteoporosis • Rheumatology • COL1A2

Single Dose of SHR-1222, a Sclerostin Monoclonal Antibody, in Healthy Men and Postmenopausal Women With Low Bone Mass: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase I Study. (PubMed, Front Pharmacol) - P1 | "Overall, SHR-1222 was well tolerated at doses from 50 to 400 mg and is a promising new remedy for osteoporosis. Clinical Trial Registration: http://www.clinicaltrials.gov, NCT03870100."

Clinical • Journal • P1 data • Infectious Disease • Nephrology • Osteoporosis • Rheumatology • COL1A2

Liquid chromatography-mass spectrometry method for the quantification of an anti-sclerostin monoclonal antibody in cynomolgus monkey serum. (PubMed, J Pharm Anal) - "Combining the high-level anti-drug antibodies (ADAs) in these samples and the consistent quantitative results of the two methods, we found that the decreased concentration of SHR-1222 was due to the accelerated clearance mediated by ADAs rather than the interference of ADAs to the detection platform. Taken together, we successfully developed an accurate, efficient and cost-effective LC-MS/MS method for the quantification of SHR-1222 in serum samples, which could serve as a powerful tool to improve the preclinical development of antibody drugs."

Journal • Preclinical

A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial • Osteoporosis

The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects (clinicaltrials.gov) - P1; N=50; Completed; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion • Osteoporosis