Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing small molecule and biological therapeutics, announced top-line results from its investigator-initiated Brazil trial evaluating the efficacy of Proxalutamide relative to standard of care as assessed by the COVID-19 ordinal scale. In the clinical trial, Proxalutamide met the primary endpoint at day 14, demonstrating a reduction of 4.01 in WHO COVID-19 ordinal scale from a baseline of 5.663 to 1.653 in the Proxalutamide arm versus a reduction of 0.25 from a baseline of 5.618 to 5.368 in the control arm with a p value <0.0001. Proxalutamide also demonstrated a reduction in mortality risk by 92% (3.7% vs 47.6%) and shortened median hospital length stayby 9 days (median hospital stay of 5 days vs 14 days).

The investigator-initiated trial (NCT04728802), conducted by Dr. Andy Goren and Dr.Flávio Adsuara Cadegiani, is a placebo-controlled, double-blinded randomized parallel assignment and multi-center study. The trial has two cohorts (men and women) and two arms (Proxalutamide and control). It enrolled 588 patients who met the eligibility criteria within 48 hours of admission to hospital. 

In the Proxalutamide arm, patients were orally administered Proxalutamide 300mg once daily (QD) for 14 days. In the control arm, patients were orally administered placebo once daily (QD) for 14 days. Each arm also received standard of care as determined by the principal investigator at the site. The primary endpoint of the trial is the treatment efficacy of Proxalutamide relative to control, as assessed by the WHO COVID-19 ordinal scale on day 14.

The preliminary analysis conducted on March 9, 2021 was based on 294 patients (56.8% male) inthe Proxalutamide arm and 296 patients (57.8% male) in the control arm. According to the results on day 14, the mortality in Proxalutamide arm was 11(3.7%), compared to 141 (47.6%) in control arm, demonstrating a reduced mortality risk of 92%. The number of new mechanical ventilation (MV) and/ordeath in Proxalutamide arm was 13 (4.4%), compared to 156 (52.7%) in control arm, reducing mortality risk by 92%; and median hospital length stay (days) in Proxalutamide arm was 5, while it was 14 in control arm, which means Proxalutamide shortened hospital stay by 9 days.

Dr. Tong Youzhi, Founder, Chairman and Chief Executive Officer of Kintor Pharmaceutical, commented, "This trial for treatment of hospitalized COVID-19 patients was conducted in 12 sites in the Brazilian state of Amazonas, where the pandemic has been devastating. Most of the newly test-positive patients in Amazonas have been infected by the new P.1 variant, which is more contagious and has led to a higher mortality rate. We are delighted to see that Proxalutamide could significantly reduce the mortality rate, shorten the length of hospital stay, reduce the number of new mechanical ventilations (MV), and increase the percentage of discharge from hospital, thus alleviating shortages of public health resources in Amazonas. Based on thepositive results of this phase 3 trial, the treatment of COVID-19 outpatients, hospitalized patients (including those admitted to Intensive Care Units), we expect Proxalutamide could become an important tool in the global fight againstCOVID-19. We at Kintor Pharmaceuticals thank Dr. Andy Goren , Dr.Flávio Adsuara Cadegiani and the Samel Group for their continued efforts."

About Proxalutamide(GT-0918)

Proxalutamideis a nonsteroidal antiandrogen – specifically, a selective high-affinity silentantagonist of the androgen receptor – which is under development for thepotential treatment of COVID-19, prostate cancer, and breast cancer.

About Kintor Pharmaceuticals

Kintor Pharmaceuticals is developing and commercializing a robust pipeline of smallmolecule and biological drugs for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne.

[1] According to The Lancet, a 50% (n = 13,496) mortality rate was reported for in-hospital mortality in North Brazil (Amazonas). Accessed 10 March 2021. https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30560-9/fulltext