NeuroRx and Relief Therapeutics have each issued press releases enumerating disagreements between the companies regarding development of Zyesami aviptadil (RLF-100), a synthetic vasoactive intestinal peptide. The two companies are partnered on development of the formulation for the treatment of acute respiratory distress syndrome caused by COVID-19, for both intravenous and inhaled delivery. In September 2020, NeuroRx and Relief signed an agreement for commercialization of RLF-100, with NeuroRx responsible for the US, Canada, and Israel, and Relief responsible for Europe and elsewhere.
Earlier this year, NeuroRx announced the initiation of a Phase 2b/3 trial of nebulized Zyesami for the for the treatment of severe COVID-19. NeuroRx also recently signed an agreement with TFF Pharmaceuticals to explore the feasibility of formulating aviptadil as a dry powder for inhaled or nasal delivery.
According to Relief, it felt compelled to respond to an amendment to the agreement filed by Big Rock Partners Acquisition Corp, which agreed to a merger with NeuroRx in December 2020: “NeuroRx has elected to make statements in the Amendment with respect to pending disputes between Relief and NeuroRx under the terms of the Collaboration Agreement. As a result, Relief has concluded that it must inform the public about the nature of the pending disputes and its views regarding the positions regarding these issues taken by its collaboration partner.”
Relief cites a number of disputes between the two companies, including that “NeuroRx has alleged in the Amendment that Relief has elected not to fund the recently initiated clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, Relief has requested certain information required for it to determine whether or not to fund this trial, and NeuroRx has refused to provide the requested information that is needed by Relief to make a decision on whether or not to fund this trial. It is Relief’s position that until it is provided with sufficient information to make this decision, NeuroRx cannot bring in another source to specifically fund this trial.”
NeuroRx alleges that Relief owes money for another recent trial, and the companies are also debating who is responsible for remediation of stability problems with the aviptadil formulation. Relief also claims that NeuroRx is withholding data from a recent trial. Both companies state that they are committed to resolving their disputes “amicably,” though Relief notes that if amicable negotiations fail, it will “take all necessary actions to enforce its rights under the Collaboration Agreement.” In the meantime, NeuroRx asserts that “Relief’s failure to approve or fund the inhaled use trial has not impeded the start of that trial.”
Read the Relief Therapeutics press release.
Read the NeuroRx press release.
