The collaboration combines the proven peptide production capabilities of Biocon with the proprietary oral peptide-delivery technology of Nobex.
Biocon and Nobex also had plans to advance the oral human brain-type natriuretic peptide (hBNP) programme towards an IND (Investigational New Drug) filing with the FDA (US Food and Drug Administration) in 2007 and
clinical trials beginning later that year.
Administration of hBNP by continuous infusion was approved by the FDA in August 2001 for the treatment of acute congestive heart failure in the hospital care setting.
The intent of an oral hBNP is to have a product available for chronic use, rather than only for acute use for a number of potential indications, including early-stage heart failure patients. This will herald a new paradigm for potentially multiple indications in cardiovascular therapy.
Also earlier this year, Nobex conducted pre-clinical exploratory studies with Mayo Clinic, using a modified human brain-type natriuretic peptide (hBNP) delivered by oral administration. A paper on the results was published in the journal circulation.
The paper reports, for the first time, that the Nobex-modified hBNP had a significant reduction in mean arterial pressure and increased blood levels of a second messenger called cyclic GMP in an animal model.
The study also showed the activity of the hBNP is maintained and its oral bio-availability is several times greater than the unmodified natural peptide at the same oral dose and the same liquid formulation.