Through its developmental Advanced Immunomodulating Multi-component System (AIMS) platform, Statera has advanced several late-stage developmental product candidates that include the STAT-200 and STAT-600 AIMS programs that are evaluating noroxymorphone and proenkephalin analogs for the treatment of certain cancer, inflammatory, autoimmune, and emerging viruses.
STAT-200 AIMS™ Program
STAT-200 AIMS™ Program
noroxymorphone-n-substituted-methyl cyclopropyl
| Discovery | Lead Optimization | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | NDA |
Statera’s most advanced drug candidate, STAT-201, is focused on the restoration of mucosal healing and intestinal barrier function as an adjunct to the standard of care in moderate to severe Crohn’s Disease.
Statera’s lead investigational drug candidate, STAT-201, is expected to be studied for the treatment of pediatric patients with Crohn’s disease, an inflammatory bowel disease that causes chronic inflammation of the gastrointestinal (or digestive) tract, causing symptoms such as persistent diarrhea, abdominal pain and rectal bleeding. Studies show that because the signs and symptoms of the disease are unpredictable, patients living with the disease endure significant burdens, not only physical, but also emotional and economic.
Statera completed a productive end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding a clinical development plan for a Phase 3 clinical trial evaluating STAT-201 in pediatric Crohn’s patients. Statera plans to initiate a Phase 3 clinical trial in pediatric Crohn’s patients in 2022. The FDA has granted STAT-201 Orphan Drug Designation for the treatment of Crohn’s Disease in pediatric patients.
STAT-205 is expected to potentially treat acute and post-acute COVID infections by modulating immune system function and by decreasing elevated inflammatory responses associated with SARS-CoV-2 viral infections, making it a potential candidate for the treatment of Acute and Post-Acute COVID-19.
With the FDA having cleared the Investigational New Drug (IND) application, Statera has initiated a clinical trial in acute COVID to evaluate the pharmacokinetics and biomarkers of STAT-205. Preliminary in vitro data have shown to slow or halt the progression of SARS-CoV-2 in human lung cells, the virus that causes COVID-19.
Statera is also planning a study evaluating STAT-205 in patients with post-acute COVID-19 syndrome (PACS). Also known as “long haulers,” these patients represent a high unmet medical need as roughly 30% of all COVID-19 infections develop into long-haul syndrome.
STAT-600 AIMS™ Program
STAT-600 AIMS™ Program
TLR5 / Entolimod
| Discovery | Lead Optimization | Pre-Clinical | Pivotal Animal Studies | Human Safety / Dose Conversion |
| Discovery | Lead Optimization | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | NDA |
Statera plans to explore new indications for entolimod based on the potential of toll-like receptor 5 agonists in hematology/oncology indications, specifically for radio-mitigation as a treatment of neutropenia and anemia in cancer patients. Discussions are underway with a U.S. academic institution to initiate the first study in 2022 using entolimod in a hematology indication. Based on the data demonstrating efficacy and safety treating radio-ablative sickness, we intend to evaluate ongoing development requirements and medical needs of a Toll 5 agonist in radiation emergencies.