Proxalutamide, a selective high-affinity silent antagonist of the androgen receptor, is being developed by Chinese biotech, Kintor Pharmaceutical Limited (9939.HK).
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Brazilian President Jair Bolsonaro and his rotating cadre of health officials are back in the news with another “miracle cure” they claim will put out the COVID-19 fire raging in South America’s largest country.
Bolsonaro has previously advocated for hydroxychloroquine and claimed that Ivermectin, a widely debated treatment for head lice and river blindness in sub-Saharan Africa, could be responsible for the relatively low number of coronavirus deaths in that continent.
The latest in Bolsonaro’s line of experimental coronavirus therapies is Proxalutamide, which he announced in an April address to the nation would “soon be available to all Brazil.”
Proxalutamide, a selective high-affinity silent antagonist of the androgen receptor, is being developed by Chinese biotech Kintor Pharmaceutical Limited (9939.HK).
Kintor’s stock climbed by more than 20% as the company announced that the first patient had been dosed in a U.S. Phase III clinical trial of patients with mild-to-moderate COVID-19, and touted the claims made by Bolsonaro and mid-level health ministry official, Helio Angotti.
Angotti, an eye doctor with no epidemiological experience to speak of, has also seen his political stock rise throughout the pandemic. His position bears comparison to that of Brian Harrison, the now notorious former dog breeder with little public health experience who was put in charge of day-to-day operations during the early U.S. COVID-19 response by then Department of Health and Human Services (HHS) secretary Alex Azar.
Current and former Brazilian health ministry officials have stated that Angotti has gained power by elevating what they say is questionable science to support Bolsonaro’s beliefs – chief among them that masks are useless, lockdowns are dangerous, vaccines are suspect, and that miracle cures are available or are on the horizon. The country is on its fourth health minister since the beginning of the pandemic.
Invited by Bolsonaro to expand on Proxalutamide’s promise, Angotti referred to a domestic study that showed a 92% decrease in mortality risk among hospitalized COVID-19 patients.
“If the article is published, I believe any government in the world will pay attention,” said Carlos Wambier, a co-author of the Brazilian Proxalutamide study.
Wambier, a dermatology professor at Brown University specializing in cosmetic procedures including Botox injections and tattoo removal, acknowledged that the study lacked peer review, but said that the findings were “really very encouraging.”
The study was challenged by Sao Paulo HCor Research Institute director Dr. Alexandre Cavalcanti, who referred to a presentation by the study’s authors as “amateur”.
Cavalcanti said that the study’s claimed reduction of mortality risk was too high to be credible in light of a global struggle to find effective COVID-19 treatments.
Kintor, which has seen its market capitalization go from just HK$6.6 billion on March 1 to HK $26.97 billion at close of business on May 24, has been the subject of controversy around the US clinical trials of Proxalutamide.
Zeid Kayali, a California-based gastroenterologist who is listed as the principal investigator in documents related to the study on clinicaltrials.gov, told Reuters that he was “not in charge” of the trial and that Kintor had yet to dose a patient as of early May.
Kintor Chief Financial Officer Lucy Lu rebutted Kayali’s claims, telling BioSpace that they had completed the first U.S. patient dosing on April 24 and that “our current U.S. Phase III trial is moving on track.”
Proxalutamide is also being investigated for the treatment of metastatic breast cancer in early-stage Chinese trials.
“Initiation of this Phase III study of proxalutamide in male with mild or moderate COVID-19 symptoms in the U.S. and other countries is a key milestone in fulfilling our mission to discover and develop effective therapies for COVID-19. We have been actively initiating MRCT phase III trials in the U.S., the EU, South Africa, and South America including Brazil,” said Kintor Chief Medical Officer Dr. Xunwei Dong.
On May 18, Kintor stated that the FDA had approved the launch of a phase III trial of proxalutamide in hospitalized patients.
Brazil, which is the world’s fifth-largest and sixth-most populous country, has recorded over 450,000 deaths from COVID-19.
