Denmark-based Serendex Pharmaceuticals, a company developing drugs to treat severe respiratory conditions, recently announced the initiation of Phase I clinical trials for their drug candidate Molgradex, based on their Granulocyte Macrophage Colony Stimulating Factor (GM-CSF).
The compound uses Novozymes‘ recombinant human albumin named Recombumin as an effective, versatile stabilizer that eases the formulation of protein and peptide drugs for pulmonary delivery.
The compound prevents derivatization of the labile beneficial protein by searching against the commencement of reactive species, reducing the risk of undesirable immunological responses.
Molgradex® is a recombinant version of the human GM-CSF is aimed to treat rare pulmonary diseases such as Bronchiectasis (BE), Acute Respiratory Distress Syndrome (ARDS), Cystic Fibrosis (CF) and Pulmonary Alveolar Proteinosis (PAP).
The compound is the first inhalable option to treat these conditions and is expected to receive market authorization in 2018 for PAP. The companies have been cooperating to implement albumin in the final drug formulation.
“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,” said Kim Arvid Nielsen, CEO of Serendex in a recent news release. “It has also been important for us to have a partner capable of providing an undisputed product safety profile as well as supply security.”
The compound is used in marketed drug agents, and some pharmaceutics are assessing its efficacy in late-stage clinical studies both under United States and European Union regulations.
“We are excited about our collaboration with Serendex Pharmaceuticals,” said Peter Rosholm, Vice President of Novozymes Biopharma in the news release. “I consider it additional proof that our unique recombinant albumin products offer superior stabilizing benefits when other stabilization options fail. This provides further evidence that our well-documented products and technical support deliver value to our customers and help moving better therapies to market faster.”
“This whole process has been very fast and the collaboration with Novozymes has enabled us to quickly move to clinical trials and ultimately closer to market,” said Kim Arvid Nielsen in the news release.
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