Chinese company SciClone Pharmaceuticals has begun a clinical study of the Covid-19 inactivated vaccine combined with Zadaxin (thymalfasin) in the country.
A thymic hormone drug, Zadaxin naturally circulates in the blood. It is approved as a vaccine enhancer for treating individuals with chronic hepatitis B and immune impairment.
The prospective, open and randomised controlled study will analyse the vaccine’s safety, tolerance, and immunogenicity in healthy adult subjects.
With 15 hospitals in the People’s Republic of China participating, the study intends to enrol a total of 200 subjects.
Considering Zadaxin’s mechanism of action and prior clinical studies, the company noted that the combination could aid in boosting the SAR-Cov-2 neutralising antibody level and extend the antibody protection time.
In a separate development, Algernon Pharmaceuticals has filed an end of Phase 2 meeting request (EOP2) with the US Food and Drug Administration (FDA).
This development comes after the company concluded the Phase IIb part of its Phase IIb/III Covid-19 trial of NP-120 (Ifenprodil).
According to data from the Phase IIb part, 0% mortality was observed in the 20mg dose Ifenprodil treatment arm versus a 3.3% mortality rate in the untreated control arm, at day 15.
The goal of the EOP2 meeting is to enable discussions between the FDA and sponsors who seek guidance on the clinical trial design, to decide the safety of proceeding to Phase III, to assess the Phase III plan.
It will include interactions on protocols and endpoints for adequacy and to obtain data required to support a marketing application.
The company earlier said that it will submit a briefing package that has a summary of study data and a protocol synopsis for a potential Phase III trial as part of the filing.
According to the FDA guidelines, Algernon Pharmaceuticals should get a response within 70 days. Since the meeting is based on a Covid-19 clinical trial, the response could be expedited.