Interna Therapeutics Reports on an Ongoing Phase I Clinical Trial of an Intranasal COVID-19 Drug
December 5, 2024
Petach Tikvah, Israel – December 5th, 2024
Interna Therapeutics (Interna), a biopharmaceutical company specializing in the development of a universal platform for the delivery of macromolecule drugs into cells, reports on reaching a significant milestone of testing its COVID-19 drug in a Phase I clinical trial.
Interna’s is on a mission to solve the problem of inefficient intracellular macromolecule drug delivery by using a proprietary chemical moiety termed Molecular Nano Motor (MNM). The MNM is easily conjugated to any type of macromolecule drug (DNA, RNA, proteins) and facilitates cell entry by utilizing electrical forces of the cell membrane. Once the MNM-drug is inside the cell, the MNM is cleaved from the macromolecule drug, resulting in the entrapment of the macromolecule drug. This is a simple yet robust delivery approach which opens new treatment options for delivery of macromolecule drugs into difficult to treat organs, such as the lungs. Interna demonstrated effective MNM-siRNA lung delivery in several of its infectious and non-infectious drug development programs, including SARS-CoV-2, RSV, and idiopathic pulmonary fibrosis.
Interna’s most advanced program, is a MNM-siRNA drug targeting a conserved gene of SARS-CoV-2, intended for self-administration intranasally at home, for the purpose of pre-exposure prophylaxis, post-exposure prophylaxis, or therapeutic treatment. In response to the robust preclinical work which demonstrated therapeutic efficacy and favorable safety profile, Interna continued with the necessary steps needed to perform a Phase I clinical trial: manufacturing of GMP-grade clinical material, finding a clinical trial centre in one of Israel’s leading hospitals, and obtaining Israel Ministry of Health permission to perform the clinical trial.
The Phase I clinical trial is a randomized, double-blind, placebo-controlled single centre, study, of single- twice-daily doses, and repeated twice-daily dosing of ascending doses for up to five days. The aims of the trial are to evaluate the safety, tolerability, and systemic exposure of the MNM-siRNA drug when administered intranasally in healthy, adult subjects. Dosing began on 03/09/2024 and the trial is expected to be completed by the end of Q2 2025.