Biopharma company RedHill had previously been trialing a new drug candidate, RHB-107 (upamostat) at research sites in the US, but has recently been granted approval by the South African Health Products Regulatory Authority to conduct trials in South Africa.
The drug candidate is an antiviral medication which targets the host-cells of Covid-19, and is intended to treat non-hospitalized patients of Covid in South Africa. RHB-107 interferes with the virus’s spike protein, hopefully worsening its ability to enter target cells.
The study is currently entering Phase II/III clinical trials, and involves a two-part multi centered approach utilizing parallel group trials.
The entire trial is randomized, double blinded and placebo controlled. At this stage, the study aims to discover the most effective and well tolerated dose of the drug as well as to assess the timeline of recovery following the onset of the illness and early intervention.
Speaking with Clinical Trials Arena last week, the RedHill medical Director Terry Plasse said: “South Africa, along with the US and rest of the world, urgently need the ability to easily and effectively treat Covid-19 and its variants, both inside and outside the hospital setting.
Previous stages of the clinical trials demonstrated safety and effectiveness in almost 200 subjects. Furthermore, an in-vitro study utilizing bronchial epithelial cell modelling revealed a robust hindrance of virus replication following RHB-107 administration.
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