Apogenix has reported data from the Phase II ASUNCTIS clinical trial where its immunotherapy candidate, asunercept, was shown to offer statistically significant benefits in hospitalised patients with Covid-19.
The multicentre, open-label trial analysed the safety and efficacy of asunercept in 435 moderate to severe Covid-19 patients.
These subjects were randomised into four trial arms to receive either a 25mg, 100mg, or 400mg once-a-week dose of asunercept along with the standard of care (SOC), respectively, or SOC alone.
In the trial, efficacy was evaluated against the World Health Organization (WHO)-recommended endpoints, including time to clinical improvement as per the WHO scale and death.
According to the findings, robust trends for clinical efficacy were observed in all treatment arms, showing asunercept’s strong activity.
Subjects who received the treatment had a nearly 40% quicker clinical improvement versus the control arm.
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While comparing the asunercept arms with the control, statistical significance was slightly missed. Despite this, the combined treatment groups showed statistically significant quicker clinical improvement versus SOC alone.
Subjects who received asunercept had a significant decline in all-cause mortality at all time points and for each dose versus SOC.
Safety in all asunercept plus SOC groups was in line with the SOC arm, validating asunercept’s favourable safety profile seen in all previous trials.
A completely human fusion protein, asunercept comprises the CD95 receptor’s extracellular domain and an IgG1 antibody’s Fc domain.
Under a development and marketing licence, the candidate is exclusively licensed to CANbridge Life Sciences for the Hong Kong, Macao, China, and Taiwan regions.
Apogenix CEO Thomas Hoeger said: “We are very pleased to see asunercept displaying a robust efficacy and favourable safety profile in the ASUNCTIS trial.
“Based on our promising Phase II results and given the high need for effective Covid-19 medication in hospitalised patients, we are initiating a pivotal Phase III trial (ASUCOV) with asunercept to confirm the encouraging results in a larger number of patients.”