Humanetics Corporation announced positive results from its Phase 2 clinical trial evaluating BIO 300 Oral Suspension in patients with impaired pulmonary function following COVID-19 hospitalization. The trial, which assessed the safety and efficacy of BIO 300, revealed statistically significant improvements in lung function and trends toward enhanced quality of life in treated patients.
The study enrolled 38 participants across multiple U.S. sites, led by Rany Condos, MD, of NYU Grossman School of Medicine. Patients with residual lung complications post-COVID-19 hospitalization were enrolled within two years of discharge and self-administered BIO 300 orally for 12 weeks. The trial compared lung function, exercise capacity, and quality of life against a placebo group.
Key Findings on Pulmonary Function
Participants receiving BIO 300 demonstrated a statistically significant improvement in forced expiratory volume in one second (FEV1) at 12 weeks, an effect that was sustained at 12 months. Furthermore, the study observed clear statistical trends toward improved pulmonary function, as measured by diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC) at 12 weeks, 6 months, and 12 months.
Impact on Quality of Life
In addition to pulmonary function improvements, participants treated with BIO 300 exhibited a trend toward improved quality of life, as measured by the St. George’s Respiratory Questionnaire at 6 months, which was maintained at 12 months.
Safety and Tolerability
BIO 300 treatment was well-tolerated, with adverse events consistent with those expected in this patient population. The trial identified no new safety concerns associated with the drug.
Future Directions for BIO 300
"We are highly encouraged by the results of this clinical trial, particularly the promising trends in pulmonary function improvement among COVID-19 participants treated with BIO 300," said Michael Kaytor, PhD, Vice President of Research and Development at Humanetics. "We are continuing to evaluate the data to refine our understanding of BIO 300’s efficacy in COVID-19 and its potential applications for improving patient outcomes."
BIO 300 is also under development as a medical countermeasure for the United States Department of Defense and for oncology applications to protect patients from radiation-induced side effects. Ronald J. Zenk, Chief Executive Officer at Humanetics, stated, "As BIO 300 has been shown to mitigate inflammation of the lungs and pulmonary fibrosis caused by radiation, we believe that the same effect can be shown in COVID-19 patients. We are optimistic that this treatment could be a valuable addition to the ongoing efforts to combat long COVID and other conditions with lung inflammation and are committed to evaluating its impact in future studies."
The Phase 2 trial was funded by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health.
