2021-11-15
Enrollment completed for a Phase I study of SHR-1707, an anti-β-amyloid monoclonal antibody, for the treatment of early Alzheimer's disease
Nov 15, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced the completion of enrollment for a Phase I study (SHR-1707-101) in China evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-1707, an anti-β-amyloid (Aβ) mAb, for the treatment of early Alzheimer’s disease (AD). Preliminary data showed a promising safety profile of SHR-1707 where most adverse events were mild for all doses tested. In addition to the SHR-1707-101 study, another Phase I study in healthy volunteers is ongoing in Australia to assess the safety, pharmacokinetics, and pharmacodynamics of SHR-1707 in Caucasian population.
About the Study
SHR-1707-101 is a randomized, double-blind, placebo-controlled, single ascending dose Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-1707 in 62 healthy volunteers in China. The topline results are expected in the first quarter of 2022.
About Alzheimer’s Disease
In 2020, there are over 55 million people worldwide living with dementia; most cases are caused by AD.1 While the specific causes of AD are not fully known, AD is characterized by changes in the brain – including amyloid plaques – which result in the loss of functional neurons and their connections.2 The long duration of illness before death brings significant public health impact and economic burden to the society.3 Although the etiology of AD is complex, the Aβ hypothesis is the most accepted one pertaining to the pathogenesis of AD.4 Aβ tends to aggregate due to low solubility, leading to toxicity and neuron damages.5
About SHR-1707
SHR-1707 is a humanized anti-Aβ mAb developed by Hengrui. SHR-1707 specifically binds to human Aβ fibrils and monomers with high affinity. Preclinical study results showed promising efficacy of SHR-1707 in preventing the aggregation of Aβ1-42 monomers and improving spatial memory. Moreover, SHR-1707 demonstrated a limited impact on cytokine release indicating a good safety profile.
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020.6 Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.
2. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug
3. Alzheimer’s Dement. 2021 Mar;17(3):327-406. DOI: 10.1002/alz.12328
4. EMBO Mol. Med. 2016; 8(6): 595-608. DOI: 10.1001/jamaneurol.2016.1236
5. J. Alzheimer's Dis. 2010; 19(1): 311-23. DOI: 10.3233/JAD-2010-1221
6. https://torreya.com/publications/pharma1000-report-torreya-sept2020.pdf
BD Contact
Email: bd@hengrui.com
Phone: +86-21-61053532