Value Proposition
· Intranasal inhaled formulation of nintedanib (NTB) allows for more targeted dosing.
· Minimizes risk of systemic adverse events in the lung.
· Enhances drug retention in the lung for local treatment via inhalation.
· Formulation allows for long-term storage and remote shipping.
· Surface-stabilized with adsorptive non-adhesive polymer coatings to overcome biological delivery in the lung barriers to enhance therapeutic efficacy.
Unmet Need
· Silicosis is an irreversible and progressive fibrotic lung disease caused by inhalation of large amounts of crystalline silica.
· There are no proven therapies specifically for silicosis; therefore, treatment is limited to supportive therapies such as bronchodilators and glucocorticoids. Oral formulations of nintedanib, a tyrosine kinase inhibitor, are used to treat other fibrotic lung diseases and may slow progression and relieve symptoms, but do not reverse or cure the disease with the current dosage form.
· Current oral formulations of nintedanib have an adverse side effect profile and would be required in large doses to achieve optimal therapeutic effect in the lung. A significant portion of an oral formulation will not reach the lung. Therefore, there is a strong need for nintedanib to be developed to address side effect and bioavailability concerns with current oral formulations.
Technology Description
· Current oral formulations of NTB are associated with adverse events. In order to target the lung, larger dosages would be needed to ensure proper availability at the expense of systemic toxicity.
· Researchers at Johns Hopkins have developed a nanocrystal-based suspension formulation of nintedanib (NTB), to be inhaled intranasally.
· This formulation provides enhanced stability in the body and has the ability to overcome biological delivery barriers.
· Additionally, it can be lyophilized for long-term storage and transportation.
Stage of Development
· The formula has been validated for small animal-based preclinical safety and efficacy studies.
· Looking for potential licensees to complete cGMP and GLP toxicity studies.
Publication
Andrade da Silva, L. H., Vieira, J. B., Cabral, M. R., Antunes, M. A., Lee, D., Cruz, F. F., Hanes, J., Rocco, P. R. M., Morales, M. M., & Suk, J. S. (2022). Development of nintedanib nanosuspension for inhaled treatment of experimental silicosis. Bioengineering & translational medicine, 8(2), e10401. https://doi.org/10.1002/btm2.10401: Link
