Humanetics Corporation Announces Positive Phase 2 Clinical Trial Results in COVID-19 Study Aimed at Improving Pulmonary Function

The safety and efficacy of BIO 300 was evaluated in previously hospitalized COVID-19 patients

MINNEAPOLIS--(BUSINESS WIRE)--Humanetics Corporation (Humanetics) announced today the results of its Phase 2 clinical trial of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. BIO 300 is an oral drug that patients self-administer daily for 12 weeks following hospital discharge. The study compared the lung function, exercise capacity, and quality of life in COVID-19 survivors who received BIO 300 against a placebo group.

The trial enrolled 38 participants across multiple U.S. sites (NCT04482595). Rany Condos, MD, a clinical Professor in the Department of Medicine at NYU Grossman School of Medicine and Director of its Post-COVID Program, served as the lead investigator. Patients previously hospitalized with COVID-19 complications and discharged with residual lung complications (e.g., long COVID) were eligible if enrolled within two years of discharge. Multiple pulmonary function assessments and a patient-reported quality of life questionnaire were used to evaluate BIO 300’s efficacy. Although the study fell short of its planned enrollment of 50 participants, the 20 BIO 300-treated participants within the enrolled cohort of 38 exhibited improved lung function and participant-reported quality of life compared to placebo-treated participants.

Key Trial Findings:

• Improvement in Pulmonary Function: Participants who received BIO 300 demonstrated a statistically significant improvement in pulmonary function at 12 weeks, which was maintained at 12 months, as measured by forced expiratory volume in one second (FEV1). Additionally, clear statistical trends for improved pulmonary function were observed in BIO 300-treated participants at 12 weeks, 6 months, and 12 months, as measured by the diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC).
• Quality of life: Participants treated with BIO 300 showed a clear trend toward an improved quality of life as measured by the St. George’s Respiratory Questionnaire at 6 months, which was maintained at 12 months.
• Safety Profile: BIO 300 treatment was well-tolerated, with adverse events consistent with those expected in this patient population. No new safety concerns were identified during the trial.

"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 in development as a medical countermeasure for use by the United States Department of Defense and for oncology applications to protect patients from side effects caused by radiation. "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,” said Ronald J. Zenk, Chief Executive Officer at Humanetics. “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.”

This project was funded by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, Department of Health and Human Services, under Contract HHSN272201800011C.

About Humanetics Corporation

Humanetics is an advanced clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com.