MedinCell has shared phase 1 data on the continuous daily administration of ivermectin. The results are an early step in a program that could lead to the use of a long-acting injectable formulation of the molecule.
Interest in the use of ivermectin in the treatment and prevention of COVID-19 has waxed and waned over the course of the pandemic, with initial enthusiasm generated by in vitro results giving way to doubts as a preprint on the effect of the drug on coronavirus-related deaths was withdrawn. Despite the doubts, the inexpensive drug, which is primarily used as an antiparasitic therapy, has been used widely off-label in parts of the world, and evidence of its effects continues to accrue.
MedinCell wants to contribute to the case for ivermectin. The French biotech is running a phase 1 trial to assess the effect of giving ivermectin daily, generating data to suggest the drug can safely be administered for one month at doses up to 75 µg/kg.
The data are feeding into a broader development program that is leveraging MedinCell’s BEPO drug delivery technology. MedinCell said the trial is designed to show the safety of ivermectin “when taken daily in oral form in order to simulate the continuous release of the drug by a long-acting injectable.”
Work on the long-acting injectable is advancing in parallel to the clinical trial. MedinCell said it has run in vivo tests of several injectable formulations with a view to developing a prefilled syringe of the drug that is stable for two years at room temperature.
The candidates are designed to form small subcutaneous depots of ivermectin to enable the ongoing release of the drug. By the end of 2020, MedinCell plans to start preliminary preclinical regulatory development of a candidate that could release ivermectin for one or two months. MedinCell is also working on a three-month formulation.
MedinCell is extending the release of ivermectin using its BEPO technology. The technology is based on copolymers and a biocompatible solvent that are formulated with the active ingredient. After administration, the components trap the active ingredient in a depot that then gradually degrades by hydrolysis to release the ingredient. Teva has signed up to work with MedinCell on central nervous system indications.
By applying the technology to ivermectin, MedinCell is aiming to create a product that can be used to protect people from COVID-19 or prevent disease progression in people who were recently exposed to the virus. MedinCell said it may be ready to file for approval late next year.