CombiGene AB (publ) (“CombiGene”, the “Company”) today announces that the Company, after a thorough evaluation process, has chosen the American company AmbioPharm as contract manufacturer/CDMO partner (Contract Development and Manufacturing Organization), in CombiGene’s and Zyneyro’s peptide-based pain project COZY01. AmbioPharm is a world-leading company with many years of experience in the development and manufacture of peptides, and has the full potential to be a long term partner in this project.
The choice of AmbioPharm is an important milestone in the COZY01 project. AmbioPharm can produce the COZY01 peptide in accordance with all regulatory requirements (GMP), which paves the way for both future toxicology studies and future studies in humans. AmbioPharm can also produce a commercial product and will thus be a long-term partner in the COZY01 project.
“It is very satisfying that we have now chosen AmbioPharm as our CDMO partner in the COZY01 project. The team at CombiGene and Zyneyro has conducted a thorough evaluation, which in AmbioPharm’s case also included a small-scale production of COZY01. The fact that we have now chosen a CDMO partner means that the COZY01 project has taken an important step towards being able to initiate the toxicology studies that are carried out in order to be able to submit a clinical trial application,” says CombiGene’s CEO Peter Ekolind.
About the pain program COZY
Chronic pain can be devastating for those affected. The disease also leads to enormous costs for society. Between six and eight percent of the adult population is estimated to suffer from severe chronic pain, and the societal costs of chronic pain are estimated at USD 635 billion annually in the US alone.
Conventional treatment consists mainly of anti-inflammatory drugs, antidepressants, anticonvulsant drugs and opioids (a group of substances with a morphine-like mechanism of action).
The problem with these treatments is that they are not specifically developed to treat chronic pain. The pain relief that is achieved therefore often has a number of debilitating side effects such as substance abuse problems, depression, anxiety, fatigue, reduced physical and mental ability.
The COZY program is being developed to address these enormous challenges by offering effective pain relief without the problems that today’s drugs can bring.