Suzhou, China-based Kintor Pharmaceutical Ltd. plans to study its experimental drug proxalutamide as a treatment for COVID-19 in the U.S. after a trial in Brazil is completed, CFO Lucy Lu told S&P Global Market Intelligence.
Proxalutamide is being evaluated as a therapy for prostate cancer in a mid-stage study in the U.S and has not received regulatory approval anywhere.
The company is recruiting 381 men in Brazil aged 50 years or older for the COVID-19 trial. Kintor aims to finish enrollment in the Brazil study in October and unveil preliminary data by the end of 2020.
"If all goes well, we plan to start a registration trial in the U.S. in the first half of next year," Lu said. She did not disclose the stage of the study in Brazil.
She said the company hopes to seek marketing approval for the drug as a COVID-19 therapy in the U.S. in the second half of 2021 if the trial is successful. Data from the study may also be used to seek marketing approval in China, she added.
Proxalutamide targets ACE-2 and TMPRSS2, two proteins that scientists believe are vital for the novel coronavirus — which causes COVID-19 — to bind with human cells.
Kintor Pharmaceutical CFO Lucy Lu
The Hong Kong-listed company has partnered with Irvine, Calif.-based Applied Biology Inc. for the COVID-19 trials. Lu said Kintor will hold discussions with the U.S. Food and Drug Administration on the potential trial once data from the Brazil study is released.
Kintor joins the global race to produce an effective drug or vaccine for COVID-19 at a time when many companies globally have already moved ahead in their drug development.
Among Hong Kong-listed entities, Shanghai Junshi Biosciences Co. Ltd. has teamed up with Eli Lilly and Co. to conduct trials for its COVID-19 therapy in China and the U.S, while late-stage trials have also been initiated for vaccine candidates from CanSino Biologics Inc. and Sinovac Biotech Ltd.
Zhao Bing, healthcare analyst with Huajing Securities, said it is not too late for companies such as Kintor evaluate experimental drug candidates since there are no effective treatments for the novel coronavirus yet.
"Research on potential COVID-19 drugs is still hot. Most treatments being tested currently target different symptoms of the disease and [patient groups] but are not killing the virus. However, the trial for proxalutamide is still in the early stages, so it is tough to say whether it will succeed," Zhao said.
Even if a vaccine is successfully produced, the respiratory illness known as COVID-19 is still likely to be around for at least two years since it will take time for a large proportion of the population to be vaccinated, he added.
"The development and research for COVID-19 treatments should not stop even when the outbreak is controlled or ends because the virus may mutate," Lu said in response to a question about whether Kintor is late to the race to create a COVID-19 treatment.
Kintor also plans to file an application with Chinese regulators to market proxalutamide as a prostate cancer treatment in the fourth quarter of 2020.
Lu said the company plans to hire 150 salespersons in China by the first half of next year to cover about 300 hospitals, which accounts for the majority of sales for prostate cancer drugs.
China reported about 102,500 new prostate cancer cases in 2018, according to the company's prospectus.
Kintor is also keen to sell the rights to proxalutamide in the U.S. to a global drugmaker, especially one that is strong in urology, Lu said.
In addition, the company is also considering a head-to-head trial for proxalutamide against Pfizer Inc.'s Xtandi, or enzalutamide, once the phase 2 trial in the U.S. is completed, Lu said.
Xtandi was approved by the Chinese regulator in 2019 for treating prostate cancer patients whose tumor has spread to other organs. Pfizer acquired the drug through its acquisition of Medivation Inc. in 2016.
"If the head-to-head trial succeeds, we believe the sales contribution [of proxalutamide] from the U.S. market will surpass that from China," Lu said.