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 2/3 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
NRx Pharma Files Counterclaim
Against Relief Therapeutics Over COVID-19 Candidate Rights
NRx Pharmaceuticals Inc (NASDAQ: NRXP) has filed a counterclaim against its former partner, Relief Therapeutics Holdings (OTC: RLFTF), in an ongoing dispute over the COVID-19 treatment Zyesami (avaptadil).
- NRx alleges that Relief has breached a collaboration agreement and falsely asserted worldwide right to Zyesami.
- In addition, NRx alleges that Relief board Chairman Raghuram Selvaraju and management have engaged in a "past pattern of collusion...that have led to criminal investigations, sanctions, fines, and in one case incarceration."
- The company recently submitted data for Zyesami (Aviptadil) after failing to recover on remdesivir have a 3-fold increased odds of recovery from the ICU.
- NRx is seeking $185 million in reliance and punitive damages for "libelous and extortionate behavior."
- NRx said Relief has continued to mislead the public and shareholders by claiming ownership over NRx's expanded access programs, participation in the NIH trials, and development of commercial-scale manufacturing and distribution programs.
- NRx claims all were undertaken solely by the company, and Relief refused to fund and participate.
- "We are similarly horrified that Relief's management attempted to coerce NRx into using Relief's patented formulation of aviptadil in critically-ill patients despite Relief's knowledge that the formulation was ineffective," said NRx.
- Price Action: NRXP shares are up 0.42% at $4.77 during the premarket session on the last check Thursday.
NRx Pharmaceuticals Set to Begin Next Trial of Covid-19 Vaccine
After Review of Earlier Results
NRx Pharmaceuticals Inc. said it plans to begin a Phase 2b/3 registrational trial of its Covid-19 vaccine after a review of the Phase 2 results next week by the study's data safety monitoring board.
The company also said the Israel Institute for Biological Research has posted scientific results from an initial sample vaccinated patients in order to assess the potential effectiveness of the BriLife vaccine against the Delta variant of the SARS-CoV-2 virus, which found 10 of the 11 samples tested neutralized the Delta variant.
In morning trading, NRx's shares were up 8.9% at $4.90. They have fallen 80% since the end of last year.
The company, which is developing BriLife under an exclusive license from the Israel Ministry of Defense, said early findings from the BriLife Phase 2 trial are encouraging at a time when new variants of concern threaten immunity built with first-generation vaccines for Covid-19.
The Israel Institute for Biological Research's report noted that mutations seen in the BriLife vaccine that may be responsible for effectiveness against variants occurred naturally as a function of the spontaneous acquisition of new characteristics by the live-virus vaccine, NRx said. The data suggest the vaccine may be capable of evolving to counter the Delta and other variants of concern, it said.
FDA denies EUA to NRx’s Zyesami for critical Covid-19
AZ will not pursue approval of its Covid-19 vaccine in Switzerland
The US Food and Drug Administration (FDA) has denied emergency use authorization (EUA) to NRx Pharmaceuticals’ Zyesami (aviptadil) for the treatment of critical Covid-19 patients with respiratory failure. The agency cited inadequate data on the known and possible risk-benefit profile of the therapy in people with critical Covid-19 and respiratory failure. The agency said that to date, it had assessed the safety data of only 131 randomised participants receiving the investigational therapy. NRx said it will seek to share data from at least 150 additional patients treated on the NIH ACTIV-3b trial, and that it has requested a Type A meeting with the FDA to discuss Zyesami’s development.
AstraZeneca will not pursue marketing authorisation for its Covid-19 vaccine in Switzerland. The company attributed the move to medical regulator Swissmedic’s insistence on limiting the usage of the vaccine to individuals aged 50 years and above. In October last year, AstraZeneca started rolling submissions to obtain authorisation for the shot in the country, submitting trial data and other required documents. The vaccine was found to have an encouraging reactogenicity profile and was well tolerated in people aged 18 years and above.
Novavax has concluded the rolling submission process for emergency use listing of its Covid-19 vaccine candidate, NVX-CoV2373, with the World Health Organization. The company submitted all the required modules including the chemistry, manufacturing and controls data needed by the agency to review the recombinant nanoparticle protein-based vaccine with Matrix-M adjuvant. Data from the Phase III PREVENT-19 trial in the US and Mexico are included in the filing. The vaccine was found to provide complete protection against moderate and severe Covid-19 in the trial.
By Chris Lo