Chinese Company’s COVID-19 Drug Claims Arouse Skepticism


The Chinese flag is reflected in a drop on a syringe needle in this illustration taken on November 9, 2020. REUTERS / Dado Ruvic / Illustration

Chinese biotech company Kintor Pharmaceutical Limited (9939.HK) saw its share price rise more than 20% the day after announcing on April 25 that it had “completed the first enrollment and first dosage of patients.” in a US clinical trial of its investigational treatment COVID-19.

It was the company’s latest announcement regarding the advancements of the drug, Proxalutamide. The share price of the Hong Kong-listed company has nearly quadrupled since March 1, as some analysts wrote about the great selling potential of a COVID-19 treatment. Kintor saw its market capitalization climb to HK $ 23.4 billion ($ 3 billion) from HK $ 6.6 billion on March 1.

But the company had not dosed any patients as of early May, according to doctor Kintor identified as its principal investigator of clinical trials in documents posted on a trials website in the United States. The doctor – California-based gastroenterologist Zeid Kayali – also told Reuters he was “not responsible” for the trial, contradicting what the company said in documents describing the study. Kayali declined further comments, referring questions to Kintor.

Recounted by Kayali’s comments, Kintor’s CFO Lucy Lu said Kayali was only one of the investigators in her trial. She declined to comment further on the company’s announcement on patient dosing. Lu also declined to name another lead investigator, or the institution overseeing the trial, calling the information “confidential.”

Companies are not obligated to disclose this information. But many pharmaceutical companies regularly provide details about who is leading their clinical trial and which research organization or medical institution is responsible for patient safety and scientific validity.

Kintor’s lack of transparency, along with inconsistencies in the company’s statements, raise a “red flag” over the company’s claims, said Stephen Ostroff, former chief scientist with the Food and Drug Administration (FDA) of the United States. United States and twice Acting Commissioner of the FDA.

Another red flag: Kintor has repeatedly touted a Brazilian study of Proxalutamide that claimed such a high rate of effectiveness that Ostroff and other pharmacy experts say it’s hard to believe.

The Brazilian study said that Proxalutamide showed a 92% reduction in the risk of death in hospitalized COVID-19 patients, which Ostroff said would be “breathtaking” if this were true.

Alexandre Cavalcanti, director of the HCor Research Institute in Sao Paulo, called a presentation of the study’s results by its authors “amateurish” and said its alleged reduction in the risk of mortality is too high to be credible. in light of a global struggle to find effective COVID-19 treatments.

Kintor shares briefly turned negative in Hong Kong morning trading, but traded over 4% at 0303 GMT, putting it on track for its third straight session of gains.

STOCK RECEIVES A BOOST

Proxalutamide does not have regulatory approval and is not available for sale. The Brazilian study of the drug has not been peer reviewed or published, but the authors released a brief presentation of its findings at a press conference in March. Kintor promoted their findings.

“Based on the positive results … we anticipate that Proxalutamide could become an important tool in the global fight against COVID-19,” Kintor Managing Director Tong Youzhi said in a statement announcing the Brazilian results on March 11.

On the same day, the Kintor share price jumped almost 9%.

Lu, Kintor’s chief financial officer, did not respond to detailed questions from Reuters about criticism of the Brazilian study and Kintor’s claims about his trial in the United States.

One of the study’s authors, Brown University dermatology professor Carlos Wambier, dismissed his criticisms and called his results “very encouraging.”

In an April 2 client note, analysts at Beijing-based brokerage firm China Renaissance cited Kintor’s progress reports as evidence of “the potentially wider application of Proxalutamide.” They gave the stock a “buy” recommendation and set a target price of HK $ 50.75. Kintor’s shares are now trading at around HK $ 66, after hitting a record high of HK $ 82 in late April.

“The share price is primarily influenced by clinical advances related to COVID-19,” said Sam Hu, analyst at CMB International in Hong Kong.

One of the authors of the study is a consultant hired by an official of the Brazilian Ministry of Health, an ally of the country’s president, Jair Bolsonaro. The president is a vaccine skeptic and a mask and lockdown critic who has promoted discredited COVID-19 remedies such as hydroxychloroquine. Health official Helio Angotti has tasked a team of consultants to find evidence to support Bolsonaro’s unsubstantiated medical claims, Reuters reported in a related article today.

Angotti declined to comment. Bolsonaro’s office did not respond to written questions from Reuters. Proxalutamide study co-author consultant Ricardo Zimerman did not respond to requests for comment.

RESEARCH AND POLICY

Lu said Kintor is in talks with Brazilian federal health regulator Anvisa to conduct its own clinical trial. Anvisa said in a statement that Kintor had not filed any formal request to conduct a lawsuit, but had not commented on any discussions between the regulator and the company.

Two Anvisa staff, speaking on condition of anonymity, questioned the results of the Brazilian study on Proxalutamide, saying the authors’ presentation of results did not contain any detailed data or evidence. One of Anvisa’s staff called the presentation more marketing than science. Brazil’s health ministry, in a technical note in March, concluded that “the evidence available for the drug is still nascent”, with limited information on safety and results.

Kintor originally designed Proxalutamide as a cancer treatment, before moving on to COVID-19. Lu told Reuters that the FDA allowed the company to move to a Phase III trial, skipping Phases I and II, after evaluating its previous oncology studies and research in Brazil. She declined to share any FDA documentation describing this clearance.

The FDA declined to comment on Kintor or his COVID-19 drug. Ostroff said it was concerning and atypical that Kintor used early stage oncology trials, as well as the questionable Brazil study, as shortcuts to a phase III COVID-19 trial. The company’s answers to basic questions about its clinical trial, he added, were elusive.

“Most pharmaceutical companies, especially those related to COVID-19, will be quite open about the types of testing they perform,” he said.

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