MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Global health agency Unitaid has awarded Medincell (Paris:MEDCL) an extension grant of up to US$ 6 million over three years to fund the clinical phase 1 activities of long-acting injectable mdc-STM. If proven safe, effective, and acceptable, mdc-STM could have a significant impact on transmission of malaria among vulnerable populations in high-transmission areas.
mdc-STM is an investigational three-month active injectable formulation of ivermectin using Medincell’s BEPO® technology to fight malaria transmission. A previous grant of $6.4 million was awarded in March 2020 by Unitaid to fund the formulation research phase and preclinical activities of the program conducted by Medincell and the project consortium members, IRD, IRSS and CIRDES.
Medincell is committed to the fight against the major global health threats, such as malaria that remains endemic in 85 countries representing 50% of the world's population. According to WHO estimates, 249 million people were infected worldwide in 2022, 94% of them in Africa, leading to 580,000 deaths in the area.
Quiterie de Beauregard, Head of Global Health Development at Medincell, said: “The 2023 WHO’s World Malaria Report highlights the significant discrepancies between the objectives outlined in the Global Technical Strategy and the status of malaria indicators. This gap is particularly pronounced in the countries initially identified as high burden, which have seen little to no change in both malaria incidence and mortality rates. In 2022, these nations represented 67% of global cases and 73% of deaths. The report emphasizes the urgent need for additional tools to curb malaria transmission. Ivermectin emerges as a highly promising solution; however, logistical challenges associated with its oral administration may hinder its potential to make a significant epidemiological impact on malaria. At Medincell, bolstered by the support of the IVERMEN community and renewed confidence from Unitaid, we are firmly convinced that a long-acting injectable formulation could overcome these obstacles.”
Christophe Douat, Medincell’s CEO, added: "We are delighted that our long-acting injectable technology, which has reached the commercial stage following the approval of our first treatment by the US FDA, can address major global health challenges. The renewed support from Unitaid is crucial for advancing this project. It enables us to leverage our internal regulatory development expertise and continue our collaboration with consortium members IRD, IRSS, and CIRDES to conduct further studies. Our 3-month active ivermectin, if proven safe and effective, has the potential to significantly impact populations suffering from malaria."
About mdc-STM program
Ivermectin, a drug designed to combat parasites, could eliminate mosquitoes upon biting individuals or animals that have been administered it. The individual receiving the injection will not be protected against malaria directly, however the number of mosquitoes will decrease, thus benefiting the whole community by lowering the risk of transmission of malaria, particularly in children. This community-based intervention aims to disrupt the chain of transmission.
Currently in preparation, clinical trials initiation of mdc-STM is planned by the end of 2024. The product is based on BEPO®, a Medincell polymer-based injectable technology that enables the sustained release of ivermectin and has the potential from a single subcutaneous injection to protect people living in malaria-endemic areas throughout the rainy season.
This grant extension is funded through Unitaid’s IMPACT project, which aims to develop a long-acting injectable medicine that could both interrupt malaria transmission and be easier to administer and adhere to.
In 2022, Medincell signed a license agreement with The Medicines Patent Pool (MPP) that enables MPP to support the identification of suitable partners needed for the development and distribution of mdc-STM in low- and middle-income countries.
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™ (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.
UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals
About Unitaid
Unitaid saves lives by making critical health products available and affordable for people in low- and middle-income countries. We work with partners to identify innovative treatments, tests and tools, help tackle the market barriers that are holding them back and get them to the people who need them most – fast. Since its creation in 2006, Unitaid has facilitated access to more than 100 groundbreaking health products to help address the world’s biggest health challenges, including HIV, TB, and malaria; women’s and children’s health; and pandemic prevention, preparedness and response. Every year, more than 170 million people benefit from the products whose deployment Unitaid has supported.
unitaid.org
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