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Inovoio Pharmaceuticals will assess INO-3107 to eventually become the first drug indicated for the rare disease.
The US Food and Drug Administration (FDA) has accepted an Investigational New Drug application to evaluate INO-3107 for a phase 1/2 trial for the treatment of recurrent respiratory papillomatosis (RRP), according to Inovio Pharmaceuticals Inc.
If proven effective, INO-3107 could eventually become the first therapy approved to treat RRP—a rare disease caused by the human papillomavirus (HPV) types 6 and 11 infections that causes noncancerous tumor growth and can eventually progress to cancer.
“We believe this DNA medicine has the potential to provide people living with RRP a long-term, if not life-long, improvement in their disease, especially as an alternative to often successive and debilitating surgeries that may temporarily remove HPV growths from the airways but do not address the underlying recurring virus,” said Jeffrey Skolnik, MD, vice president of clinical development at Inovio, in a statement.
The open-label, multi enter phase 1/2 trial is designed to include approximately 63 subjects in the US. Inclusion criteria require participants to have undergone at least 2 surgical interventions per year for the past 3 years for the removal of associated papilloma.
During the study, participants will undergo surgical removal of their papilloma and then receive 4 doses of INO-3107 every 3 weeks. The primary efficacy endpoint for the trial will be a doubling or more in time between surgical interventions following the first dose of INO-3107 to the frequency prior to study therapy.
Inovio Pharmaceuticals also disclosed their plans to expand the trial to included pediatric patients as well as a potential booster regimen. Additionally, the company hopes obtain an Orphan Drug Designation from the FDA.
“Our mission at Inovio is to rapidly provide patients with urgent health needs access to our novel DNA medicines,” said J. Joseph Kim, PhD, president and chief executive officer of Inovio, in the aforementioned statement. "We are pleased the FDA has authorized our INO-3107 clinical trial, and look forward to working closely with the RRP patient and medical community to drive recruitment as quickly as possible."