Ashvattha Therapeutics Subsidiary Orpheris Announces Completion of Phase 1 Study of OP-101 Subcutaneous Formulation

REDWOOD CITY, Calif.- --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 results from a Phase 1 single administration study evaluating the subcutaneous (SC) formulation of OP-101 (4 or 8 mg/kg) in healthy volunteers.

OP-101 selectively targets reactive macrophages responsible for hyperinflammation leading to lung injury and multi-organ failure in severe COVID-19 patients. It is the only clinical-stage therapeutic with the ability to shutdown multiple pathways causing hyperinflammation. OP-101 is currently in a randomized, double blind, placebo controlled, Phase 2 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OP-101 in patients with severe COVID-19.

The Phase 1 study demonstrated that a single subcutaneous dose Phase 1 study of OP-101 (4 or 8 mg/kg) in healthy volunteers is well tolerated with only mild transient injection site reactions and no other adverse events. This study was conducted with a new drug formulation that may be used for both subcutaneous (SC) and intravenous (IV) administration. These safety findings support the use of the maximum planned IV dose (8 mg/kg) in the Phase 2 clinical study of severe COVID-19 patients. With the flexibility to use the new formulation for IV and SC administration, Orpheris intends to expand the applications of OP-101 into chronic inflammatory and neuroinflammatory indications. Preclinical studies have demonstrated that OP-101 and other drugs conjugated to the hydroxyl dendrimer persist for up to one month at the site of inflammation while systemically cleared within 2 days potentially enabling once per month SC dosing.

“We found subcutaneous doses of OP-101 at 4 and 8 mg/kg in healthy subjects to be very well tolerated, apart from very minor and transient injection site reactions,” said Sepehr Shakib, Primary Investigator and Professor of Clinical Pharmacology, Royal Adelaide Hospital in Australia.

“We are pleased that OP-101 continues to show an impressive safety profile with both the IV and SC administration, and we believe that the SC administration could be a convenient and flexible route of dosing for patients. OP-101 has completed two human safety studies at doses up to 5-10-fold higher than proposed doses in our Phase 2 study in severe COVID-19 patients. We believe there is strong scientific rationale for the development of OP-101 to treat severe COVID-19 patients based on its unique mechanism of action targeting reactive macrophages, as well as in other indications such as cytokine release syndrome and acute respiratory distress syndrome,” said Jeffrey Cleland, Ph.D., Chairman, CEO & President at Ashvattha Therapeutics and Executive Chairman of Orpheris.

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.