NeuroRx, Inc. and TFF Pharmaceuticals, Inc. are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement). Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI (aviptadil, synthetic VIP) materials to TFF in order to perform feasibility formulation work and testing. The goal of this feasibility work is to formulate and identify an optimal, long-term stable formulation of ZYESAMI into a dry powder form, which has superior aerosol properties for delivery directly to the lungs.
ZYESAMI is a synthetic form of a naturally occurring peptide found in the lung called Vasoactive Intestinal Peptide (VIP), which is known to protect the Alveolar Type II cell that is targeted by the SARS-CoV-2 virus. The symptoms of COVID-19 are attributable to decreased surfactant production and increased cytokine production caused by Coronavirus infection of the Type II cell. This may also be a common pathway in sepsis-induced Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor induced pneumonitis associated with certain cancer drugs.
Loss of surfactant production in the lung may be the direct cause of the profound hypoxia or respiratory failure seen in COVID-19. The ability to deliver VIP directly to the lung via inhalation could have important therapeutic implications and potentially broaden the application of the drug to patients less severely affected with COVID-19.
“We are excited that ZYESAMI has demonstrated a highly significant reduction in time to hospital discharge for seriously ill COVID-19 patients treated with High Flow Nasal Oxygen, along with an increased likelihood of recovery and excellent safety,” said Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx. “Although our current production methods yield a drug that is sufficiently stable for emergency use, a long-term, shelf-stable formulation will be needed for ongoing use of ZYESAMI, once the pandemic subsides. The thin-film freezing technology holds great promise in potentially making this available to patients with other stages of COVID-19 with an inhaled form of ZYESAMI.”
“The work being done by the NeuroRx team with ZYESAMI on behalf of critically ill patients with COVID-19 respiratory failure is both remarkable and gratifying,” said Glenn Mattes, President & CEO of TFF Pharmaceuticals. “The potential opportunity to bring this important new therapeutic to patients earlier in the treatment cycle is exciting. We are very pleased to be collaborating with the NeuroRx Team with our thin-film freezing technology.”