Ashvattha Therapeutics Subsidiary Orpheris Announces FDA Agreement to Initiate Phase 2 Study Evaluating OP-101 in Severe COVID-19 Patients

Orpheris, a subsidiary of Ashvattha Therapeutics, a biotech company focused on developing novel dendrimer-based therapies to treat unmet medical needs in inflammatory, oncology, and ocular diseases today announced the U.S. Food and Drug Administration (FDA) has agreed to a Phase 2 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OP-101 in patients with severe COVID-19.

The primary problem in severe COVID-19 patients is an exacerbated immune response leading to hyperinflammation, tissue damage, and the need for supportive oxygen therapy. OP-101 selectively targets reactive macrophages, reducing the pro-inflammatory cytokine storm and oxidative stress in multiple animal models of inflammation. OP-101 is the only clinical-stage therapeutic with the ability to shutdown multiple pathways causing hyperinflammation.

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled evaluation of the safety, tolerability, and efficacy of OP-101 in patients with severe COVID-19 as defined by the World Health Organization's ordinal score. An evaluation of reduction in pro-inflammatory markers (CRP, ferritin, and IL-6) after treatment with OP-101 is also included in the study. All patients will continue to receive standard of care.

A single IV dose Phase 1 study of OP-101 (20 or 40 mg/kg) in normal healthy volunteers demonstrated that OP-101 is generally well tolerated in healthy subjects based on an assessment of clinical and laboratory adverse events. No deaths, SAEs, or adverse events leading to discontinuation occurred during the study. A single subcutaneous dose Phase 1 study of OP-101 (4 or 8 mg/kg) in healthy volunteers demonstrated that OP-101 is well tolerated with only mild transient injection site reactions and no other adverse events.

"We believe there is strong scientific rationale for the development of OP-101 to treat severe COVID-19 patients. The health of these patients often rapidly deteriorates due to the unchecked immune response to the virus leading to hyperinflammation and cytokine storm," said Jeffrey Cleland, Ph.D., Chairman, CEO & President at Ashvattha Therapeutics and Executive Chairman of Orpheris. "The hydroxyl dendrimer component of OP-101 enables targeting to reactive macrophages, which are responsible for hyperinflammation, lung injury, and multi-organ failure caused by COVID-19. OP-101 normalizes reactive macrophages, shuts down the cytokine cascade and reduces oxidative stress to arrest hyperinflammation. We look forward to this clinical evaluation of OP-101, as there are currently no FDA approved treatment options to treat hyperinflammation in severe COVID-19 patients."

About Ashvattha Therapeutics

Ashvattha Therapeutics holds the exclusive rights to a novel hydroxyl dendrimer technology developed at Johns Hopkins University enabling a new class of targeted therapies previously unachievable with traditional drug moieties. Ashvattha is commercializing the technology through new entities established to develop therapeutic opportunities within specific fields and enabled through the use of our dendrimer platform. For more information, visit: www.avttx.com

About Orpheris

Orpheris is a clinical stage company leveraging a novel platform technology from Johns Hopkins that enables targeting to reactive macrophages and microglia. Orpheris is focused on developing compounds to treat inflammation and specifically neuroinflammation. Hydroxyl dendrimers have been shown to cross the blood barrier and be taken up selectively by reactive microglia in multiple animal models including aged normal animals and Alzheimer's disease models. In a number of neurodegenerative diseases such as ALS, Parkinson's, and Alzheimer's, reactive microglia are shown to be responsible for the increased neuroinflammation, subsequent neuronal loss and disease progression in these patients.