Onyx helps to accelerate TopiVert’s compounds to clinic

With support from the CRO, TopiVert has been able to accelerate scale-up and produce GMP batches, which are now being used in clinical trials.

The CRO and small-scale API specialist has assisted TopiVert with the rapid development of two key drug compounds. The biotech company is developing next-generation medicines for the treatment of chronic inflammatory diseases of the gastrointestinal (GI) tract and the eye.

An oral formulation of TOP1288 has just entered a first-in-man Phase I study for the treatment of ulcerative colitis (UC), while a Phase IIa study with a rectal formulation continues to progress in parallel. The clinical-stage biotech’s second drug candidate is TOP1630, which has commenced a Phase I/IIa proof-of-concept (POC) study, involving an ophthalmic solution, in patients with dry eye syndrome (DES) in the US.

Matthew Fyfe, head of chemistry at TopiVert, 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.”

Both of TopiVert’s products are NSKIs that target several important kinases in signalling cascades in inflammatory cells. These agents display two key attributes which promise enhanced efficacy and improved safety over current therapies, specifically, simultaneous inhibition of key kinases playing pivotal roles in multiple inflammatory pathways and a localised, non-systemic mode of action. Clinical results are expected from both studies in the second half of this year.

Denise Bowser, commercial director at Onyx Scientific, said: “We have supported TopiVert from a very early stage and are really pleased to see them progress their compounds into clinical trials.

“They are a great example of a drug developer that has been able to speed up the development process by utilising our integrated approach with regards to solid state chemistry, salt screening, GMP synthesis and API manufacturing.”