Jemincare group has announced the completion of the Phase I clinical trial of its self-developed anti-SARS-CoV-2 neutralising antibody, JMB2002.
The single centre, randomised, double-blind, placebo-controlled, single-dose escalation trial assessed tolerability, safety, pharmacokinetic characteristics and immunogenicity of JMB2002 in healthy subjects.
The company commenced the trial in January. It enrolled 40 participants in four groups to receive low to high doses of the antibody.
All 40 subjects completed the trial, Jemincare noted.
According to the results from the trial, grade 2 adverse events (TEAE) associated with the study drug were reported in one subject.
The other TEAEs were observed to be grade 1 and all TEAEs were in remission or fully recovered.
No trial subjects experienced any serious adverse events (SAE) related to the antibody.
With regard to pharmacokinetics, after a single intravenous infusion of JMB2002, the maximum concentration (Cmax) and area under the curve (AUC) raised on increasing dosage while the time to reach Cmax (Tmax) reduced with the rise in dosage.
No substantial differences in the parameters such as T1/2, Vz, CLz, λz and MRT were reported among various dose groups.
In terms of immunogenicity, an anti-drug antibody was observed in one subject before and after the treatment while no anti-drug antibodies were seen in other trial subjects.
The trial findings show that JMB2002 can be progressed to additional assessment in clinical efficacy study in Covid-19 patients, in a bid to offer the antibody as Covid-19 treatment.
Currently, Jemincare is developing novel broad-spectrum neutralising antibodies to deal with the viral escape challenge.
So far, the research and development (R&D) team has developed second-generation neutralising antibodies with increased neutralising activity against all variants of concern such as the Alpha, Beta, Gamma and Delta variants in the pseudo-virus neutralising assay.
In addition, these antibodies could be offered as a cocktail treatment that offers additional options to manage the Covid-19 pandemic situation and to prevent the immune-escape of SARS-CoV-2.