Augmenta Bioworks and TFF Pharmaceuticals have announced that in vitro testing of their AUG-3387 dry powder monoclonal antibody has demonstrated that the mAb neutralizes the SARS-CoV-2 Delta variant, the highly transmissible strain that is currently dominant in numerous countries. In vitro tests had already demonstrated that the mAb could be effective against other variants of concern, including the Alpha, Beta, Gamma, and Kappa variants.
In November 2020, the two companies announced that they had partnered to develop inhaled dry powder mAbs for the prevention and treatment of COVID-19. The announcement confirms that they intend to develop AUG-3387 as an inhaled treatment for the prevention of COVID-19 in people who are at high risk for severe disease and for the treatment of patients at high risk who have been diagnosed with COVID-19 but have not been hospitalized.
According to the announcement, the formulation of AUG-3387 for use in preclinical trials has been finalized; in vivo efficacy studies are expected to begin within a few weeks; and toxicology studies are expected to begin by the end of the year. The companies also indicated that the formulation is being designed for delivery “via already approved commercial dry powder inhaler devices.”
Augmenta Bioworks CEO Christopher Emig said, “We are very excited about these new data, which reinforce our view that AUG-3387 could represent an important new class of biologic-based treatment modalities that can effectively target the emerging and potentially more pathogenic variants of the SARS-CoV-2 virus. As global health officials look for innovative solutions to help curb human-to human spread of coronaviruses, we expect the treatment landscape for COVID-19 to evolve so that scalable, biologic-based therapies can play a more prominent role in efficiently combating viral transmission, particularly with respect to new, more infectious COVID-19 variants.”
TFF Pharmaceuticals CEO Glenn Mattes commented, “The rapid progress we are making with respect to generating positive in vitro data speaks to the enthusiasm both TFF and Augmenta have for evaluating the potential of AUG-3387 to combat all prevalent forms of the SARS-CoV-2 virus. Our collaboration also demonstrates how combining two highly innovative and complementary technology platforms can accelerate rapid advancements in drug development to address severe threats to global public health. We look forward to reporting further updates on the AUG-3387 program later this year.”
Read the TFF Pharmaceuticals and Augmenta Bioworks press release.
