NRx Pharmaceuticals pursues Covid-19 vaccine as it continues work on treatment candidate
A Main Line biopharmaceutical company that is already developing a Covid-19 treatment is targeting the first quarter of this year to begin mid-stage testing of a potential vaccine for the virus.
The company, Radnor-based NRx Pharmaceuticals, also filed a counterclaim earlier this week — seeking $185 million in damages — as part of an ongoing dispute with a collaboration partner for its Covid-19 therapy known as Zyesami.
Representatives of NRx (NASDAQ: NRXP) met last week with experts from the Israel Institute for Biological Research to review data and research related to the ability of the BriLife Covid vaccine to induce neutralizing antibodies against the omicron variant.
NRx is developing the BriLife vaccine, which was originally developed by the Israel Institute for Biological Research, under an exclusive licensing agreement it signed with the Israel Ministry of Defense in July.
Based on the preliminary study findings, NRx is currently designing a Phase ⅔ study of the effectiveness of BriLife to serve as a booster to protect against Covid-19 variants including omicron.
Patients in the study will be fully vaccinated with mRNA vaccines. The company anticipates that the study will begin in the first quarter of 2022 in Israel and then expand in coordination with the health ministries of several countries.
NRx is coordinating study plans with the U.S. Health and Human Services Biomedical Advanced Research and Development Authority and several unnamed European governments.
The Israel Ministry of Health has approved the first-in-human trial of an intradermal BriLife vaccination, with the objective of enhancing immune response.
“We have seen the deadly impact caused by Covid-19 and its increasing number of variants, and we are eager to determine the immunity- building impact the BriLife vaccine may offer,” said Dr. Jonathan Javitt, chairman and CEO of NRx. “We are working closely with the experts at the [Israel Institute for Biological Research] to design a study that we hope increases BriLife’s accelerated path to regulatory approval.”
NRx is also continuing the late-stage development of its Covid-19 treatment Zyesami.
Dr. Jonathan C. Javitt, chairman and CEO of NRx Pharmaceuticals. ALON RON
Last week, the company filed a second emergency use authorization application with the Food and Drug Administration for Zyesami as a treatment for critical patients with Covid-19 who are at immediate risk of death from respiratory failure despite treatment with other approved therapies.
On Monday, NRx filed a lawsuit against Relief Therapeutics, its one-time collaboration partner, in New York State Supreme Court. The lawsuit alleges Relief Therapeutics is in breach of their collaboration agreement and that the company has made false claims about holding worldwide rights to aviptadil, the active ingredient in Zyesami.
NRx, in its lawsuit, is seeking the monetary damages and a declaration that the collaboration agreement between the companies has been canceled because Relief Therapeutics allegedly failed to fund research and clinical trials as obligated under their agreement.
Relief Therapeutics of Geneva, Switzerland, said in a statement that NRx’s lawsuit contains inaccurate information and Relief believes that the collaboration agreement between the parties with respect to aviptadil “remains in full force and effect,” and that it is NRx, and not Relief, that is in breach of the agreement. The company also called NRx’s request for $185 million in damages “illogical and unsupported.”
Relief Therapeutics filed a lawsuit against NRx’s predecessor company, NeuroRx, in October alleging NeuroRx breached their collaboration agreement by failing to provide Relief with certain aviptadil clinical trial test data and not allowing Relief to conduct a forensic audit of NeuroRx’s financial records.
NRx said on Friday it provided all financial records to Relief on Dec. 6.
The dispute is scheduled for an arbitration session in February.
By John George
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