A nonsteroidal antiandrogen (NSAA), classified as a selective, high-affinity silent antagonist of the androgen receptor (AR), currently under development by a Chinese biotech company was selected by a team of Brazilian clinical investigators to determine if the drug could treat COVID-19, reducing mortality risk while condensing median hospitalization duration. An investigator-initiated trial (meaning sponsored by the physician/researchers), namely Dr. Andy Goren and Dr. Flavio Adsuara Cadegiani involving 12 trial sites across Brazil under the Applied Biology Inc. umbrella, the results may have pleasantly surprised all as the randomized, placebo-controlled, double-blinded, parallel assignment study revealed that Proxalutamide lessened the mortality risk associated with COVID-19 by 92% while the actual duration of hospitalization condensed by a median of nine (9) days. As might not be surprising, these tremendous results received little media attention in any mainstream press. Note that this study was conducted in a region of the world with a high death rate associated with severe COVID-19 and hospitalization. The study sites involved hospitals in North Brazil (Amazonas) and by mid March, according to The Lancet, this region experienced a 50% (n=13,496) mortality rate.
Launched in February, 2 2021 according to Clincialtrials.gov, the clinical trial (NCT047288012) concluded in late April and targeted 590 participants 18 years of age and up.
With two groups (cohorts) by gender and two study arms, including the study drug and a control, a total of 588 patients ended up enrolled in the study. Participants entered the study diagnosed with a WHO COVID-19 Ordinal Scale clinical status of 3, 4 or 5 where 3 equals hospitalized patients requiring oxygen therapies, 4 equals those hospitalized patients in need of oxygen by mask or nasal prongs, and 5 equals those severely ill, hospitalized patients on non-invasive ventilation or high-flow oxygen.
Patients in the study drug arm received the Proxalutamide 300 mg once daily for 14 days while the control arm the patients received a placebo for 14 days plus the standard of care for that particular trial site facility in Brazil.
The targeted endpoints of this clinical trial were met with the study drug serving to significantly reduce WHO Ordinal Scale scores by day 14 of the study. For example, the study drug contributed to a reduction of 4.01 from baseline (5.663 to 1.653) as compared to control with a lessening of 0.25 from baseline (5.618 to 5.368).
The study drug actually reduced overall patient mortality risk by a significant 92%. For a sense of comparison, in the control arm, that is the arm where patients received a placebo and standard of care, 141 people died. In the study arm, only 11 patients died by day 14, making the mortality rate 3.7% for a high risk group.
Moreover, treatment with this investigational drug condensed median hospital duration by nine days, that is 5 days with Proxalutamide and 14 days in the control group. By day 15, 89.1% of patients treated with the study drug were actually discharged as compared to just 32.8% in the placebo arm.
Kintor Pharmaceutical Limited develops and commercializes a pipeline of small molecule and biological drugs 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. According to Crunchbase, the company is privately held and has raised just under $100 million by the D round.
In a press release the founder of the drug’s developer, Kintor Pharmaceutical Limited shared, “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 the positive results of this Phase III 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 against COVID-19.”