VIRO Pharmaceuticals will use the DioRaSSP (Diosynth Rapid Solution Synthesis of Peptides) process, first introduced in 2003, for the development and production of its peptide drug VIR-576, designed as a treatment for HIV infection.
DioRaSSP is a liquid phase technology that combines some of the characteristics of solid phase technologies. A spokesperson for the comany said that it follows a generic protocol so that development and scaling of new synthesis routes is very fast. Moreover, it ensures the complete removal of excess (active) reagents by a new quenching procedure, which results in products of high purity.
However, unnlike some solid phase-based syntheses, scale-up problems are avoided, she added. Using DioRaSSP, one single manufacturing process will be used from initial lab-scale synthesis up to industrial scale production. This is a unique feature of the technology, according to Diosynth, and makes this technology 'a very attractive solution to industrial challenges in the development of new pharmaceutical peptides'.
VIRO intends to conduct its clinical Phase I and II trials with API produced by Diosynth. The API in VIR-576 is composed of 2 identical peptide chains of 20 amino acids each, linked by a disulfide bridge, and was developed by IPF Pharmaceuticals, a subsidiary of Pharis Biotec to which VIRO also belongs.
Recently, VIRO successfully completed first round financing and is now ready to go ahead with the first part of a clinical trial programme for VIR-576 showing the safety and clinical efficacy of the drug candidate.