China race for Covid-19 pill treatment hit by low hospital cases

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China's front-running experimental drug to treat Covid-19 has suffered a setback, with a late-stage trial on outpatients failing because of a low number of hospitalisations. Kintor Pharma's candidate Proxalutamide — administered as a simple pill — has been undergoing phase 3 trials in the US, Brazil, China and the European Union to test its safety and efficacy for prostate and...

China's front-running experimental drug to treat Covid-19 has suffered a setback, with a late-stage trial on outpatients failing because of a low number of hospitalisations.

The interim analysis involved 348 patients with mild-to-moderate Covid-19 symptoms from the US, where the hospitalisation rate is "very low", the company said. "When the rate of hospitalisation for Covid-19 has dropped to two or three per cent, it is very difficult for the drug to reduce this rate again, and a drug is supposed to further reduce the rate. It is very difficult for a small sample trial to reflect a statistical difference."The trial involved male and female patients with one or more mild Covid-19-related symptoms within five days of onset.

Kintor will seek approval from drug regulators, including the US Food and Drug Administration, to amend the protocol and continue to enrol higher risk Covid-19 patients in further trials, the company said.A small-molecular pill developed by Merck and approved for emergency use in the US was tested on outpatients who were unvaccinated and had at least one risk factor associated with poor disease outcomes, such as heart disease and diabetes.

 

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