Valuable researchers have reported encouraging results from a pivotal phase 1/2 clinical trial evaluating PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis (RRP), a rare and debilitating condition caused by chronic infection with HPV types 6 and 11. RRP leads to the development of papillomas in the aerodigestive tract, causing significant voice disturbances and airway obstruction, with no systemic treatment currently available.
In this single-arm trial, 38 adult patients received PRGN-2012 following surgical debulking. Among the 35 patients treated at the recommended phase 2 dose, 51% achieved a complete response, meaning they did not require additional interventions to control RRP in the 12 months following treatment. Importantly, the treatment was well-tolerated, with mild adverse events such as injection site reactions, fatigue, chills, and fever.
These promising results mark a significant step forward, with a biologics license application planned for submission to the FDA, positioning PRGN-2012 as a potential FDA-approved treatment for adults with RRP.
