NeuroBo Pharmaceuticals has obtained a recommendation from the independent Data Monitoring Committee (DMC) to continue the Phase II/III clinical trial of its lead drug candidate, ANA001, for treating Covid-19 without any changes.
The move comes after the committee reviewed safety data from 36 subjects who received treatment with ANA001 in the trial.
ANA001 is a proprietary oral formulation of niclosamide, which features antiviral and anti-inflammatory properties.
The two-part multicentre, placebo-controlled double-blind Phase II/III trial is analysing the safety, tolerability and efficacy of ANA001.
Being carried out in the US, both phases of the trial will have subjects suffering with moderate to severe Covid-19 who are in hospital but do not need ventilators.
These subjects will be given ANA001 plus standard-of-care therapy for seven days.
The Phase II trial anticipates recruiting 60 subjects with a primary goal to analyse the safety and tolerability of the drug.
Efficacy measurements such as median time to hospital discharge and pharmacokinetics will be included as secondary goals.
The Phase III segment will enrol several hundred subjects.
Median time to hospital discharge, safety and tolerability will be the primary goals of this phase, while clinical improvement and the requirements and time for rescue treatment will be the secondary goals.
NeuroBo president and CEO Richard Kang said: “The DMC’s recommendation to continue enrolment of the Phase II/III clinical trial, without modification, is an important milestone for our lead drug candidate, ANA001, as a potential treatment for Covid-19.
“We expect to complete the Phase II portion of the trial in the fourth quarter of this year and to achieve a number of value-creating milestones with this programme in the coming months, including initiation of the Phase III of trial.”
In a separate development, TC BioPharm has commenced a Phase I/II trial of its allogeneic gamma-delta T cell product, ImmuniStim, in subjects with Covid-19 in the UK.