Vasoactive Intestinal Peptide Expands 'Right to Try' Programs for Severe COVID-19

Pennsylvania-based NRx Pharmaceuticals today announced enhancements to its Expanded Access and Right to Try programs. These programs enable patients with respiratory failure from COVID-19 who have tried all approved medicines who cannot participate in clinical studies, to receive ZYESAMI® (aviptadil) upon a physician's prescription.

Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970.

Hospitals that enroll in the U.S. FDA-supervised Expanded Access Program (EAP) can store ZYESAMI on-site and provide it to patients without delay.

Patients who are hospitalized at facilities not enrolled in the EAP program may be treated under the Right to Try Act, which does require an application to NRx by a licensed, accredited critical care physician and review by the Company's medical team.

ZYESAMI remains an investigational medicine not approved by the U.S. FDA and is a long-term stable form of the vasoactive intestinal peptide, which was previously shown in clinical trials to be associated with a two-fold increased odds of survival at 60 days.

The subgroup of patients treated with ZYESAMI after remdesivir and other approved therapies demonstrated a 2.8-fold increased odds of recovering from respiratory failure by day 28 (P=.03), which was sustained to day 60, together with a four-fold increased odds of surviving to day 60 (P=.006).

"Given the urgency caused by the Omicron surge, we have worked with our manufacturing partner to increase production to a level that supports expanded access to our investigational medicine ZYESAMI, potentially at all U.S. hospitals," said Prof. Jonathan C. Javitt, M.D., MPH, CEO, and Chairman of NRx Pharmaceuticals, in a press statement issued on January 18, 2022.

"We will continue to increase production to meet (clinical) demand to offer one last option to patients who have exhausted all currently approved therapies."

The U.S. NIH is currently studying ZYESAMI as part of its ACTIV-3b (TESICO) trial.

NRx Pharmaceuticals is located in Radnor, PA, and is also developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research.