Noveome Biotherapeutics has launched a new programme to assess its ST26 product candidate for the treatment of the severe inflammatory cytokine storm response associated with COVID-19, the disease resulted due to the novel coronavirus SARS-CoV-2.
According to the company, the new programme is based on data showing that ST266 significantly decreased the inflammatory response of a body in a range of diseases and conditions.
Preventing or reducing the severe cytokine storm will help reduce the shortage of ventilators.
Noveome, which is engaged in the discussions with the FDA to quickly complete an IND, is currently searching clinical sites for a Phase 1/2 safety trial that is expected to be commenced in the fourth quarter of this year.
Noveome’s ST266 is a cell-free platform biologic that included hundreds of anti-inflammatory proteins.
The collection of proteins, dubbed secretome, will be facilitated by a novel population of cells derived from the amnion that is collected from donated, full-term, cesarean-sectioned placentas.
The ST266 secretome is said to preserve cellular survival and rejuvenate damaged cells. Noveome also claimed that ST266 has a proven safety profile and treated 242 patients with no drug-related serious adverse events.
At present, the ST266 is being assessed in multiple ophthalmic indications, including a phase 1 open-label clinical trial to establish the safety of ST266 when delivered intranasally to glaucoma suspects.
The phase 2 open-label clinical trial is assessing the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs).
Noveome founder, chairman and CEO William Golden said: “As we continue to learn from the emerging data on COVID-19, it is clear that mitigating the cytokine storm associated with severe cases is crucial to treating this condition and improving patient outcomes.
“Based on our positive preclinical and clinical data, we believe that ST266 has the potential to reduce the severe inflammatory response in patients with COVID-19 and we have initiated our efforts to evaluate ST266 in these patients.”
Separately, Sanofi’s vaccines global business unit Sanofi Pasteur has collaborated with Translate Bio for the development of a novel messenger RNA (mRNA) vaccine for COVID-19.