Pneumagen has announced that a Phase 1 dose escalation study of its Neumifil carbohydrate binding module nasal spray demonstrated that the nasal spray was well tolerated and had no dose limiting toxicity. Pneumagen announced the initiation of the Phase 1 trial in November 2021. The company previously announced data from pre-clinical studies showing that Neumifil has potential activity against SARS-CoV-2 as well as rhinoviruses, influenza, and RSV.
Earlier this year, Pneumagen said that it had raised £3.8 million for GMP manufacturing and Phase 2 development of Neumifil. The company now says that it expects to initiate a Phase 2 proof-of-concept human influenza challenge study later this year, and that study will be followed in 2023 by studies of Pneumifil in respiratory disease patients who suffer from exacerbations caused by viruses.
Pneumagen Chief Medical Officer Geoff Kitson said, “The availability of an effective intranasal broad-spectrum anti-viral therapeutic for patients who experience viral induced exacerbations of underlying pulmonary pathology would be transformational and would provide an early treatment option with significantly improved quality of life. This successful Phase 1 safety study is the first important step in our development path that could make Neumifil available to vulnerable and at-risk patients, offering them protection against a range of respiratory viruses.”
CEO Douglas Thomson commented, “We are encouraged by these first clinical data, which confirm that Neumifil is well tolerated and safe. These data represent the first clinical evidence supporting the development of this new intranasal therapeutic for patients who experience viral induced exacerbations of chronic lung disease, including those with COPD and asthma. Neumifil has the potential to deliver a significant impact on decreasing the risk of hospitalization, complications, and death for the many susceptible patients around the world.”
Read the Pneumagen press release.