TopiVert and Onynx initiate clinical trials of NSKI drugs


UK-based biotechnology firm TopiVert has initiated clinical trials of two of its narrow spectrum kinase inhibitor (NSKI) drug candidates TOP1288 and TOP1630 with support from contract research organisation (CRO) Onyx Scientific.

TOP1288 is a small molecule designed to target various kinases involved in signalling cascade that occurs in inflammatory diseases, while TOP1630 is being developed to treat underlying inflammation in dry eye syndrome (DES).

Onyx is aiding TopiVert in the accelerated development of the drug candidates and their evaluation.

TopiVert chemistry head Matthew Fyfe said: “We have been working with Onyx Scientific for several years and they have consistently delivered high-quality API for IND-enabling toxicology studies and early phase clinical trials on time and in a cost-effective manner.

"Supported by their technical team, we have been able to accelerate, scale-up and produce GMP batches, which are now being used in our clinical trials. It has been a great collaboration all round."

“Supported by their technical team, we have been able to accelerate, scale-up and produce GMP batches, which are now being used in our clinical trials. It has been a great collaboration all round.”

TOP1288 is being assessed in a Phase I trial to treat ulcerative colitis (UC) and in a Phase IIa trial as a rectal formulation, while TOP1630 is undergoing a Phase I/IIa proof-of-concept (POC) trial as an ophthalmic solution for the treatment of US patients with DES.

With results estimated to be available in the coming months, TOP1288 and TOP1630 are expected to demonstrate increased safety and efficacy compared to existing therapies.

The drug candidates are believed to have the potential to improve simultaneous key kinases inhibition with a localised and non-systemic mode of action.