The French biotech company MedinCell announced it has treated the first participants in the SAIVE study last week, the 400-participant, multicenter, randomized, double-blind, placebo-controlled study with an independent Data Monitoring Committee, conducted in the European Union Interim data are expected mid-2022 SAIVE aims at validating the efficacy in prophylaxis against Covid-19 of administration of Ivermectin in oral daily form. It is part of MedinCell’s program to develop a subcutaneous injection that could offer more than 3 months of protection against Covid-19 and its variants SAIVE follows a Phase 1 clinical study conducted by MedinCell that successfully confirmed the safety of daily, oral Ivermectin administration over a long period of time.
TrialSite has chronicled MedinCell’s efforts to commercial ivermectin as a treatment targeting COVID-19. With the most recent update Joël Richard, Chief Development Officer at MedinCell reported “Ivermectin has many modes of action identified and is not only a broad-spectrum antiparasitic agent. There is favorable data published about the prophylactic efficacy of Ivermectin against Covid-19 that must be confirmed by clinical studies conducted in accordance with regulatory authorities’ standards. Oral daily administration was chosen to simulate the pharmacokinetic profile, i.e. the circulating drug concentration in the blood, from our long-acting injectable formulation. The data from SAIVE will be analyzed by an independent Data Monitoring Committee and will help inform its future development steps.”
The Ivermectin-based Program
MedinCell’s program aims at protecting against Covid-19 with a subcutaneous injection of a long-acting formulation of Ivermectin available in the form of a pre-filled syringe, ready-to-use, with 24-month stability at room temperature. MedinCell’s BEPO® technology will allow the formation of a small subcutaneous depot, fully bioresorbable, at the time of injection. It will act as a biodegradable mini-pump that releases Ivermectin regularly until it is completely bio-resorbed.
A long-acting injectable formulation of Ivermectin could be an additional tool to protect from Covid-19, especially for nonrespondents to vaccines, such as immunocompromised people and elderlies, and for those with poor access to vaccines or potential treatments.
A more than 3-month active formulation is ready to enter regulatory development.
The safety of the daily administered Ivermectin dose set at 100 μg/kg was validated during a Phase 1 clinical study conducted by the company.
About MedinCell is dedicated to give access to revolutionary medical treatment technologies to all, regardless of local economic conditions. Thanks to our versatile drug delivery technology and research achievements in controlled release of treatments, we aim to bring a paradigm shift in patient care. MedinCell already targets several therapeutic areas with long-acting medicines that will soon allow better compliance, increased patient safety, and optimized treatment efficacy.Subscribe to the Trialsitenews “Ivermectin” ChannelNo spam – we promise
The company strives to make medicine better, affordable, and sustainable. To achieve it, they rely on strong collaborations, with the academy, NGOs, and industrial partners. Their approach to market needs relies on tight interactions with patients and practitioners, so they can express the unmet medical needs they face, and they can work on relevant and efficient solutions.