Chinese firm's COVID-19 drug claims draw scientists' skepticism

Kintor Pharmaceutical

14/05/2021 02:30

By Gabriel Stargardter
    May 14 (Reuters) - Chinese biotech firm Kintor
Pharmaceutical Limited  9939.HK  saw its stock price jump by
more than 20% the day after it announced on April 25 that it had
"completed the first patient enrollment and dosing" in a
late-stage U.S. clinical trial of its experimental COVID-19
treatment.
    It was the company's latest announcement about the progress
of the drug, Proxalutamide. The Hong Kong-listed company's stock
price has nearly quadrupled since March 1 as some analysts wrote
about the big sales potential for a COVID-19 treatment. Kintor
has seen its market capitalization soar to HK$23.4 billion ($3
billion) from HK$6.6 billion ($850 million) on March 1.
    But the company had not dosed any patients at all as of
early May, according to the doctor Kintor identified as its
principal clinical trial investigator in documents it posted on
a U.S. trials website. The doctor - California-based
gastroenterologist Zeid Kayali - also told Reuters he was "not
in charge" of the trial, contradicting what the company had said
in the documents describing the study. Kayali declined further
comment, referring questions to Kintor.
    Told of Kayali's comments, Kintor Chief Financial Officer
Lucy Lu said Kayali was merely one of its trial investigators.
She declined further comment on the firm's announcement on
patient dosing. Lu declined as well to name a different
principal investigator, or the institution overseeing the trial,
calling that information "confidential."
    Companies are not obligated to release such information. But
many pharmaceutical firms routinely provide details about who is
leading their clinical trial and which research organization or
medical institution is responsible for ensuring patient safety
and scientific validity.
    Kintor's lack of transparency, along with inconsistencies in
the company's statements, raise a "red flag" about the company's
claims, said Stephen Ostroff, a former U.S. Food and Drug
Administration (FDA) chief scientist and two-time acting FDA
commissioner.
    Another red flag: Kintor has repeatedly touted a Brazilian
study of Proxalutamide that claimed an effectiveness rate so
high that Ostroff and other pharmaceutical specialists say it is
hard to believe.
    The Brazil study said Proxalutamide showed a 92% reduction
in mortality risk among hospitalized COVID-19 patients, which
Ostroff said would be "breathtakingly extraordinary" if true.
    Alexandre Cavalcanti, director of Sao Paulo's HCor Research
Institute, called a presentation of the study's findings by its
authors "amateur" and said its claimed reduction of mortality
risk is too high to be credible in light of a global struggle to
find effective COVID-19 treatments.
    
    STOCK GETS A BOOST
    Proxalutamide does not have regulatory approvals and is not
available for sale. The Brazil study of the drug has not been
peer-reviewed or published, but the authors released a short
presentation of its results during a March news conference.
Kintor promoted their findings.
    "Based on the positive results ... we expect Proxalutamide
could become an important tool in the global fight against
COVID-19," Kintor's Chief Executive Tong Youzhi said in a
statement announcing the Brazilian results on March 11.
    That same day, Kintor's stock price jumped by nearly 9%.
    Lu, Kintor's CFO, did not answer detailed questions from
Reuters about the criticisms of the Brazil study and Kintor's
claims about its U.S. trial.
    One of the study's authors, Brown University dermatology
professor Carlos Wambier, dismissed its critics and called its
results "very encouraging."
    In an April 2 client note, analysts from Beijing-based
brokerage 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 stock now trades at
about HK$66, having reached a record high HK$82 in late April.
    "The stock price is majorly driven by the COVID-19-related
clinical progress," said Sam Hu, analyst at CMB International in
Hong Kong.
    One of the study's authors is a consultant hired by a
Brazilian Health Ministry official who is an ally of the
country's President Jair Bolsonaro. The president is a vaccine
skeptic and a critic of masks and lockdowns who has promoted
discredited COVID-19 remedies such hydroxychloroquine. The
health official, Helio Angotti, assigned a team of consultants
to find evidence to support Bolsonaro's unfounded medical
claims.
    Angotti declined to comment. Bolsonaro's office did not
respond to written questions from Reuters. The consultant who
co-authored the Proxalutamide study, Ricardo Zimerman, did not
respond to requests for comment.
    
    RESEARCH AND POLITICS
    Lu said Kintor is in talks with Brazilian federal health
regulator Anvisa about conducting its own clinical trial. Anvisa
said in a statement that Kintor had not filed any formal request
to conduct a trial, but did not comment on any talks between the
regulator and the company.
    Two Anvisa staffers, speaking on condition of anonymity,
questioned the results of the Brazilian Proxalutamide study,
saying the authors' results presentation contained no detailed
data or evidence. One of the Anvisa staffers characterized the
presentation as more marketing than science. Brazil's Health
Ministry, in a March technical note, concluded that "the
available evidence for the drug is still incipient," with
limited information on safety and outcomes.
    Kintor originally conceived of Proxalutamide as a cancer
treatment, before pivoting to COVID-19. Lu told Reuters that the
FDA had allowed the firm to progress to a Phase III trial,
skipping Phases I and II, after evaluating its previous oncology
studies and the Brazil research. She declined to share any
documentation from the FDA outlining that permission.
    The FDA declined to comment on Kintor or its COVID-19 drug.
Ostroff said it was concerning and atypical that Kintor used
earlier-stage oncology trials, along with 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 evasive.
    "Most pharmaceutical companies, especially related to
COVID-19, will be quite open about what sorts of trials they're
doing," he said. 

 (Reporting Gabriel Stargardter; editing by Michele Gershberg
and Brian Thevenot)
 ((gabriel.stargardter@thomsonreuters.com))