NRx Pharmaceuticals (NASDAQ: NRXP) has entered an agreement with MannKind Corporation (NASDAQ: MNKD) for ZYESAMI (aviptadil) dry powder formulation development.
MannKind’s Technosphere platform to develop Aviptadil
Aviptadil is a synthetic Vasoactive Intestinal Peptide produced to help in protection against inflammations. The drug will be developed on MannKind’s established Technosphere platform, which provides the foundation for the FDA-approved Afrezza inhaled insulin medication.
In June 2020, the US FDA granted NRx a Fast Track Designation for the use of aviptadil in the treatment of COVID-19-associated Acute Lung Injury/Acute Respiratory Distress Syndrome. In a phase 2b/3 clinical trial, the investigational medicine showed a more than 2-fold enhanced chance of survival at 60 days and considerably reduced IL-6 cytokine production (also known as cytokine storm) compared to control. The US National Institutes of Health, the Biomedical Advanced Research Development Authority (BARDA), and NRx are funding phase 3 clinical trials for ZYESAMI inhaled and intravenous formulations.
NRx CEO Jonathan Javitt said, “As we continue to identify the beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers multi-year stability at room temperature is key to meeting the needs of patients. I had the privilege of working closely with Dr. Alfred Mann, on the refinement and regulatory approval of MannKind’s Technosphere platform and have long admired its simplicity and elegance. On many occasions, he and I discussed his vision to extend Technosphere beyond insulin to solve the unique stability and administration challenges of peptide-based drugs.”
MannKind is delighted to partner with NRx on ZEYSAMI
MannKind CEO Michael Castagna added, “We are looking forward to the collaboration with NRx and looking for an avenue to marry the benefits of our Technosphere technology with ZYESAMI. Our focus is to continue to explore ways that our Technosphere technology can deliver unique compounds in a targeted and convenient manner for patients with serious lung diseases.”
