Serendex Pharmaceuticals, Novoenzymes’ Therapy For Cystic Fibrosis, Molgradex, to Begin Clinical Trials

Denmark-based Serendex Pharmaceuticals, a company developing drugs to treat severe respiratory conditions, recently announced the initiation of a Phase I clinical trial 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. Improving immune system responses is important for people with CF, who frequently have to fight off bacterial infections in the lungs.

Molgradex, a recombinant version of the human GM-CSF is targeted towards treating rare pulmonary diseases such as Cystic Fibrosis (CF), Bronchiectasis (BE), Acute Respiratory Distress Syndrome (ARDS), and Pulmonary Alveolar Proteinosis (PAP). The therapy 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.

Cystic fibrosis (CF) is a life-threatening genetic disease that primarily affects the lungs and digestive system. An estimated 30,000 children and adults in the United States (70,000 worldwide) have CF.

In people with CF, a defective gene and its protein product cause the body to produce unusually thick, sticky mucus that clogs the lungs, obstructs the pancreas and stops natural enzymes from helping the body break down food and absorb vital nutrients. Serendex believes that Molgradex could help to mitigate these health risks in CF patients and offer a viable, new therapeutic option.