Innovent Biologics (Suzhou) Co. Ltd. announced that the first patient has been dosed in the phase 3 study assessing IBI311 for the treatment of thyroid eye disease (TED).
Give me a quick rundown on Innovent Biologics.
Based in China, the biopharmaceutical company is focused on the development, manufacturing, and distribution of monoclonal antibody drug candidates in treating oncology, autoimmune, cardiovascular, and ophthalmology diseases.
Now talk about IBI311.
IBI311 is a recombinant anti-insulin-like-growth factor-1 receptor (IGF-1R; a transmembrane tyrosine kinase receptor involved in development, metabolism, and immune regulation) monoclonal antibody that targets the following actions in TED patients:
- Binding IGF-1R and blocking its signal activation pathway mediated by IGF-1 and other related ligands or agonistic antibodies
- Reducing the expression of downstream inflammatory factors
- Inhibiting inflammatory reactions like tissue congestion (i.e. proptosis, etc) and edema (i.e. periorbital, conjunctival, eyelid, etc)
- Prevent adipocyte cellularization of orbital fibroblasts (OFs; in which often include overexpressed IGF-1R)
Any prior data on it?
Yes! A phase 2 study (NCT05795621), noted a favorable safety profile and significant efficacy signals, including a regression of exophthalmos and clinical activity score (CAS) improvement.
How were the patients separated?
According to Clinical Trials, patients were randomly assigned to either IBI311 or a placebo on Day 1 in a 2:1 ratio (arranged by smoking status) and followed for 21 weeks for a total of eight infusions.
And the dosages?
Dosages for the IBI311 experimental arm included 10 mg/kg on Day 1, followed by 20 mg/kg every three weeks for the remaining 7 infusions; the placebo comparator arm received the following in two stages:
a) placebo from baseline to Week 9 every three weeks for the first four infusions, then
b) IBI311 dosed at 10 mg/kg at Week 12 followed by 20 mg/kg every three weeks for the remaining four infusions, from Week 9 to Week 21.
What was being assessed?
The primary outcomes measure included the proptosis responder rate of patients’ study eye, determined by the percentage of patients with a a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) at Week 12.
See here for secondary outcome measures.
The study is expected to be concluded by February 2024.
And this phase 3 trial?
RESTORE is a randomized, double-masked, placebo-controlled, phase 3 clinical study evaluating the efficacy of IBI311 in improving proptosis in TED subjects to support the potential new drug application of IBI311.
The primary endpoint is the difference in the improvement in proptosis degree responder rate of the study eye in the treatment group compared with the placebo group at week 24.
Significance?
According to Lei Qian, MD, PhD, vice president of clinical development at Innovent, due to no targeted therapy approved in China, there is a significant unmet medical need for TED patients.