Danish company Serendex announced it has begun Phase I trials of Molgradex, a recombinant version of human granulocyte macrophage colony stimulating factor (GM-CSF).
The drug candidate uses Novozymes’ recombinant human albumin, Recombumin, as a stabiliser to help delivery of the biologic to the lungs.
The drug is easily broken down into a different chemical structure, which could provoke a dangerous immunological response in patients. Recombumin’s job is to prevent this unwanted derivatisation by scavenging against chemically reactive molecules.
Serendex is developing Molgradex to treat rare pulmonary diseases such as Pulmonary Alveolar Proteinosis (PAP), Acute Respiratory Distress Syndrome (ARDS), Bronchiectasis (BE) and Cystic Fibrosis (CF). The company aims to make it the first inhalable drug for these diseases with a launch of Molgradex for PAP in 2018.
Serendex CEO Kim Arvid Nielsen said the two companies worked closely to formulate the drug with albumin before first-in-human studies:
“Novozymes Biopharma has been instrumental in smoothly moving our drug candidate through development and regulatory filings. Their regulatory and technical product support has been of great value to us in preparation for our clinical trials.
“It has also been important for us to have a partner capable of providing an undisputed product safety profile as well as supply security.”
Recombumin is already present in several biopharmaceuticals and drug products on the market. Novozymes has a supply agreement for the albumin with MSD for its MMR II and Proquad vaccines.
Other companies experimenting with inhalable biopharmaceuticals include Sanofi and MannKind, and Pfizer – all with mixed success.