As the world is seeing a new wave of COVID-19, China’s potential experimental drug to combat respiratory illness has been hit with a setback due to late-stage trials on outpatients failing as a result of a low number of hospitalizations.
Proxalutamide, made by Kintor Pharma and expected to be administered via a simple pill has been being undergoing trial phases in different parts across the globe such as the United States, Brazil, EU, and China.
The drug’s efficacy is being put to test for prostate and breast cancers, and also COVID-19.
“Statistical criteria were not met at an interim analysis of the phase 3 outpatient study,” the company announced on Monday night.
However, the analysis made showed that there were no safety concerns as well as no adverse events were reported relating to the drug.
Another interim analysis was done on some 348 patients with mild-to-moderate COVID-19 symptoms from the US, where the hospitalization rate is “very low”
The results were then shared by Kintor’s chairman and CEO Tong Youzhi who also noted that the results were related to the changed COVID-19 situation in the United States.
In a conversation with a popular Chinese news site Yicai, Youzhi said that vaccination had reduced the number of severe cases in the US and the treatment environment for patients with the illness was also improving.
Patients are now younger, and young people fare better than the elderly with Covid-19, Tong said.
“When the rate of hospitalization for Covid-19 has dropped to 2 or 3 percent, 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 conducted trial involved both male and female patients with one or more mild COVID-19-related symptoms within five days of onset.
Also, those who participated in the trial were randomized to receive about 200mg of Proxalutamide or a placebo twice daily for 14 days.
The enrolment also covered the entire population while also including patients with a vaccination history, as well as those without any risk.
The primary endpoint was the percentage of all-cause deaths and hospitalizations for a period exceeding 24 hours by day 28.
Kintor is now requesting approval from drug regulators including the US Food and Drug Administration in order to amend the protocol and continue to enroll higher risk COVID-19 patients in further trials.
Participants should have multiple co-morbidities and/or can be unvaccinated for Covid-19.
This past week, the US FDA approved Merck’s COVID-19 pill for emergency use and was also tested on outpatients who were unvaccinated and had at least one risk factor associated with poor disease outcome including heart disease and diabetes.
A Pfizer pill, which has also been approved for emergency use in the US, was tested on patients with at least one underlying medical condition associated with an increased risk of developing severe illness from Covid-19.
“The Covid-19 pandemic continues to evolve with the Omicron variant highlighting the need for therapeutics,” Tong said.
“It is important to investigate new modalities to treat those infected with the virus. We believe Proxalutamide could become an important tool in the fight against Covid-19 infection and will continue to investigate its use.”
Tong also made it known to investors via a telephone meeting on Tuesday morning that the company would provide the drug to all countries for free, for compassionate use in treating mild and severe illnesses, according to ThePaper.cn.
China has already approved its first Covid-19 treatment – an antibody cocktail developed by Brii Biosciences – but it needs to be administered intravenously.