Kintor Pharmaceutical Announces Successful Proxalutamide COVID-19 Phase III Clinical Trial Initiation and Patient Dosing in U.S.

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 on March 1.

proxalutamide

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 The Brazil study of the drug has not been peer-reviewed or published, but the authors released a short presentation of its results during a March news conference.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%.

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.

“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.

Kintor Announced on May 18, 2021 (1) FDA Has Greenlighted Proxalutamide’s Phase III Study for Hospitalised Male and Female COVID-19 Patients to Be Conducted; and (2) Inclusion of Female Outpatients in Proxalutamide’s Phase III Study for Mild to Moderate COVID-19

Kintor Pharmaceutical Limited (HKEX.9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has greenlighted proxalutamide's phase III clinical trial of hospitalised COVID-19 patients to be conducted, which will recruit both male and female patients. Separately, the FDA agreed to the addition of female patients to its ongoing proxalutamide phase III clinical trial in outpatients with mild to moderate COVID-19 illness. The company will publish and update details of these pivotal studies at ClinicalTrials.gov.

Dr. Youzhi Tong, Founder, Chairman, and CEO of Kintor Pharmaceuticals, commented, "We have been planning to conduct a pivotal multi-regional clinical trial of proxalutamide for the treatment of hospitalised COVID-19 patients in approximately ten countries. That the US FDA greenlighted the proxalutamide phase III clinical trial for hospitalised patients to be conducted paves the way for us to accelerate the study process. At the same time, the FDA agreed to include female subjects in our ongoing phase III clinical trial of outpatients with mild to moderate COVID-19 illness. We look forward to reporting proxalutamide's progress in helping to combat the global COVID-19 pandemic."

About the Study

The phase III trial is a randomized, double-blind, placebo-controlled, multi-regional pivotal trial, designed to evaluate the efficacy and safety of proxalutamide in male outpatients with mild or moderate COVID-19 symptoms. The primary endpoint for the trial is the percentage of hospitalization events (including death) by Day 28. The secondary endpoints of the trial include but not limited to proportion of mortality by Day 28, percentage of patients achieving each clinical status on Days 7, 14 and 28 using National Institute of Allergy and InfectiousDiseases (NIAID) 8-point scoring scale.

About Proxalutamide (GT-0918)

Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer.

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne. For more information, visit www.kintor.com.cn.

Proxalutamide COVID-19 Studies

June 11, 2021: Goren et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (preprint 12/30/2020) (Peer Reviewed, Provisionally Accepted)
Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429.
Goren et al., Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 14 authors.

March 10, 2021: Cadegiani et al., Press Conference (Preprint) - Late Treatment Study
The Proxa-Rescue AndroCoV Trial
RCT 590 hospitalized patients, 294 treated with proxalutamide showing significantly lower mortality and faster recovery.
Cadegiani et al., Double Blind Randomized Controlled Trial, Brazil, South America, preprint, baseline oxygen requirements 97.0%, 5 authors.

Feb 22, 2021: Cadegiani et al., Cureus, doi:10.7759/cureus.13492 (Peer Reviewed Early Treatment Study)
Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial
RCT 234 mild-moderate COVID-19 patients with 171 treated with proxalutamide, showing significantly faster viral clearance and recovery.
Cadegiani et al., Double Blind Randomized Controlled Trial, Brazil, South America, peer-reviewed, 8 authors.

Comments

Popular Posts