PITTSBURGH, PA – June 23, 2021 – Noveome Biotherapeutics, Inc. (Noveome) announced that it has commenced its Phase 1 clinical trial by dosing its first patient. This Phase 1 trial is evaluating the safety and tolerability of intravenous (IV) administration of their ST266 product to treat deadly inflammatory responses in COVID-19 patients. ST266, a novel platform biologic that possesses anti-inflammatory and neuroprotective properties, already has Phase 1 and Phase 2 clinical study data through other forms of administration.
ST266 is an investigational treatment for severe systemic inflammation, known as a cytokine storm, and ultimately sepsis, which is frequently associated with infectious diseases such as COVID-19. Sepsis accounts for nearly $24 billion in annual costs in the U.S. alone, making it the most costly condition for the healthcare system to treat. Previous preclinical and clinical studies have demonstrated that ST266 has the potential to significantly reduce this inflammatory response.
“When successful, this study will advance tools to treat one of the world’s most prevalent and deadly conditions, sepsis. The impact of ST266 on the inflammatory response in COVID-19 patients will give us an understanding of the drug’s ability to treat this response across a wide variety of bacterial, fungal and viral infections,” said Christopher Velis, CEO of Noveome.
To date, Noveome has received approximately $115 million in grant funding from the U.S. Department of Defense and approximately $10 million from other public and private sources to support their studies. This study brings them one step closer to translating ST266 out of the lab and to patients in need.
The clinical outcome status of ST266-treated patients and the potential effects on clinical laboratory parameters and inflammatory markers will be monitored from baseline through the post-treatment follow-up period. These effects with be observed through clinical and serologic assessments that are measured for the duration of the trial.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. In addition, the Phase 1 trial described above, the company recently announced the results from their Phase 2 open-level clinical trial evaluating ST266 as a treatment for Persistent Corneal Epithelial Defects (PEDs). ST266 was found to be both safe and beneficial in treating PEDs. A Phase 2b PED trial is scheduled to begin in the third quarter of 2021. The company also recently announced positive preliminary safety results for its Phase 1 transcribriform delivery of intranasal ST266 for traumatic brain injury and diseases of the retina and optic nerve. For more information, please visit www.noveome.com.
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