MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
In vivo studies demonstrated the feasibility of three new long-acting injectable treatments:
mdc-GRT (organ transplant), mdc-KPT (pain / animal health) and mdc-TTG (Covid-19)
The MedinCell team has selected the lead formulation and started the regulatory preclinical development of those three programs.
« With the admission of three new products into preclinical development and the achievement of this milestone for our contraceptive program last April, our team has achieved its goals” stated Christophe Douat, CEO of MedinCell. “The most advanced product of our portfolio – whose pivotal Phase 3 ended with positive results – is only the tip of the iceberg. On top of this product which is about to enter the final stage of the approval process, Phase 3 should start this year for two other products”.
The three new programs into regulatory development are:
mdc-GRT: organ transplant - molecule: Tacrolimus
This treatment is intended to prevent graft rejection in organ transplant patients. It uses Tacrolimus, an immunosuppressant already widely used, as the active ingredient. In addition, to improve compliance, a major issue in patients who have received a transplant associated with a necessary lifelong treatment, this product could reduce the risk of adverse effects. The regulatory activities that have just begun should make it possible to launch the first-in-human study in 2022.
mdc-KPT: pain in animal health - molecule: confidential
MedinCell’s first animal health program, mdc-KPT is a 5- to 7-day treatment targeting acute pain for pets, based on an active ingredient already widely used. The regulatory activities, which have just started, should enable the beginning of the product’s clinical trials before the end of 2021.
mdc-TTG: Covid-19 - molecule: Ivermectin
The objective of MedinCell's mdc-TTG program is to protect humans from Covid-19 and its variants with a long-acting injection of Ivermectin. A first formulation candidate potentially active for more than a month has entered regulatory preclinical development. The context of the pandemic could lead to approval in 2022.
In addition, in April 2020, MedinCell announced the regulatory development of the mdc-WWM program, a contraceptive administered by subcutaneous injection, fully bioresorbable and active for six months. This program is developed with the support of The Bill & Melinda Gates Foundation through a grant of up to $19 million over four years to fund preclinical activities and initial clinical studies, scheduled to begin in 2023.
MedinCell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 130 people representing over 25 different nationalities.