Global contract development and manufacturing organisation (CDMO) Recipharm is partnering with Ahead Therapeutics to develop a ground-breaking treatment for a rare autoimmune disease, myasthenia gravis. Ahead Therapeutics is a Spanish start-up biotech company, using proprietary technology to develop treatments for different autoimmune disorders.
Under the agreement, Recipharm will provide analytical and process development capabilities to support toxicology studies, as well as GLP manufacturing of lipid nanoparticles to encapsulate the active pharmaceutical ingredient, an antigen peptide. Recipharm also offers the capacity to scale up manufacturing, ready for commercialising the therapy.
Myasthenia gravis is a rare autoimmune disease that most commonly affects the muscles controlling the eyes and eyelids, facial expressions, chewing, swallowing, and speaking, but can also impact other parts of the body. It is estimated that the condition affects roughly 150,000 people worldwide. At present, there is no cure and treatments are chronic and symptomatic.
Dr. Martí Dalmases Arnella, CEO of Ahead Therapeutics, said: “Autoimmune diseases affect approximately one in ten individuals, meaning 0.8 billion patients globally will be able to benefit from the drugs derived from our platform. Recipharm is dedicated to helping organisations like ours that work to develop treatments for rare diseases. This agreement represents a key milestone and the beginning of an exciting journey. Recipharm is the pharmaceutical industry’s best-in-class provider of contract development and manufacturing solutions, and we are looking forward to working closely with the team on this project.”
Ulrike Lemke, President of Recipharm’s Sterile Fill & Finish business unit added: “There are more than 7,000 rare diseases that need a cure. We are proud to be partnering with Ahead Therapeutics and look forward to providing a GLP environment to scale up production for a vital treatment to tackle what is currently an unmet patient need. Together with our partner, we are determined to help them turn hope into reality for people living with myasthenia gravis. We have the expertise to help Ahead Therapeutics bring drugs to market faster, so they can continue to deliver on their promise to change patients’ lives.”
Ahead Therapeutics has extensive experience in fighting autoimmune conditions, as well as other orphan diseases. Its newly developed solution for myasthenia gravis — intended for parenteral administration — is based on the use of phospholipid liposomes containing the antigen peptide. Through a biomimetic process, these liposomes can induce antigen-specific immune tolerance, thereby interrupting the autoimmune reaction. By changing the encapsulated autoantigen, the technology can address the treatment of different auto-immune diseases, Type 1 Diabetes; Multiple Sclerosis; and Celiac Diseases, among others.
