BEIJING (Reuters) -China’s Kintor faced a temporary setback as interim analysis for a late-stage trial for its potential COVID-19 pill did not yield sufficient data due to the lack of hospitalised cases, sending its shares crashing as much as 85% on Tuesday morning.
In a trial designed to study how well Kintor Pharmaceutical Inc’s proxalutamide tablet could cut hospitalisation for outpatients, which had recruited more than 300 people, less than 10 people with initially mild or moderate illness were hospitalised by the time of interim analysis, Kintor chairman Tong Youzhi said on a call with investors on Tuesday.
The potential reason for the lack of hospitalisation so far in the trial included the expansion of vaccination drive in the United States and the relatively young age of participants, which averaged 38 years, Tong said.
This is not yet a failure of the drug, but a reading that cannot draw a statistically significant conclusion for now, leaving the company unable to deliver a result on the drug’s efficacy in reducing hospitalisation, a Kintor spokesperson said late on Monday.
Kintor’s stock plunged to as low as HK$6.91 on Tuesday morning, the lowest since the company listed its shares in May 2020.
“One of the issues caused by the unsatisfactory interim analysis could be the delay in the company’s business plan,” Tong said, but added that Kintor will continue to push forward the existing trials.
Kintor said in a filing on Monday that it will seek consent from authorities including the U.S. Food and Drug Administration to amend clinical protocol and continue to enroll patients of higher risk, such as those who have not received a COVID-19 vaccination.
The company is also testing proxalutamide in already hospitalised COVID patients, and developing other potential treatments for diseases including cancers and hair loss.
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