Atea Pharmaceuticals has dosed the first subject in the Phase III MORNINGSKY trial of oral antiviral AT-527 in mild or moderate Covid-19 patients in an outpatient setting.
A direct-acting antiviral, AT-527 is derived from Atea’s purine nucleotide prodrug platform.
Atea is currently developing AT-527 for Covid-19 treatment in partnership with Roche.
The global, multi-centre, randomised, double-blind, placebo-controlled trial will assess the efficacy, safety, pharmacokinetics and antiviral activity of AT-527 in mild or moderate Covid-19 patients.
It will enrol around 1,400 non-hospitalised adult and adolescent patients who will be randomised within five days of onset of symptoms.
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Atea has initiated subject enrolment at clinical trial sites outside the US, while the MORNINGSKY trial will have several clinical sites across the globe, including in Japan.
Time to alleviation or improvement of Covid-19 symptoms will form the trial’s primary endpoint.
The number of subjects needing medically attended visits or hospitalisation will be included as other efficacy endpoints. The study will also detect and/or analyse biomarkers that are predictive of an antiviral response to AT-527 as other secondary and exploratory endpoints.
Atea Pharmaceuticals founder and CEO Jean-Pierre Sommadossi said: “This pivotal milestone demonstrates a focused effort with our strategic partner Roche to globally advance the development of an oral therapeutic for Covid-19 that has the potential for broad use in early stages of the disease.
“With the initiation of this global Phase III programme, we are one step closer to achieving our goal of providing an easily administered oral, direct-acting antiviral in the fight against this global pandemic.”
In another development, Reven Holdings has dosed the first subject in the Phase I/II trial of RJX in high-risk Covid-19 patients.
RJX is an intravenous formulation of a patented pharmaceutical composition that has a specific mixture of antioxidant and anti-inflammatory ingredients.
Reven noted that the subject rapidly responded to protocol therapy with normalisation of the inflammation markers and resolution of hypoxemia.
Furthermore, the subject no longer needed supplemental oxygen therapy or hospitalisation and was discharged from the hospital on the fifth day.