UCB Pharma has plans for a bridging study later this year of UCB0107 in progressive supranuclear palsy (PSP) patients, according to Tim Buchanan, the company’s director of experimental medicine, speaking on the sidelines of the recent International Congress of Parkinson’s Disease and Movement Disorders (MDS 2019) in Nice, France.
The bridging study will be necessary to provide the safety and pharmacokinetic (PK) data needed to advance the anti-tau drug into a Phase III trial planned for the second quarter of 2020, he said. UCB announced Phase III plans on 25 September in a press release. PSP is an uncommon brain disorder that causes serious problems with walking, balance and eye movements.
Buchanan declined to comment on the target enrolment size for the bridging study but said the design is likely to be similar to the Phase I trial, including approximate patients per dose cohort and study period. It will recruit mostly in the EU, but it could also recruit in the US, he said.
The placebo-controlled bridging study will explore the top few doses of the original seven doses explored in the Phase I trial (NCT03464227), Buchanan said. He declined to reveal the doses used in Phase I, but noted the lowest two doses were subtherapeutic and had been implemented at the request of regulatory agencies, adding they will likely not be used in the bridging study for safety. There were six subjects in each dose cohort that was described to be of therapeutic benefit, and outcomes were measured up to week 20. The maximum tolerated dose was not reached in the Phase I trial, and the top trial dose was still below the maximum dose tested in animal models, which means it is possible for even higher doses to be explored in a future trial, he said.
The presented 52-subject Phase I data showed that there were no safety differences in the 38 treated healthy volunteers compared to 14 volunteers who were given placebo (Buchanan, et al, Late-breaking abstract 3, MDS 2019). The most common adverse events were mild to moderate headache and back pain, and the only severe adverse event was a case of leg varicose ulceration that was determined to be not treatment-related.
It is too early to discuss Phase III trial designs until further information from the bridging study becomes available, Buchanan said.
There are no sales estimates for UCB0107, and UCB has a market capitalisation of EUR 12.8bn (US$14bn).
by Shuan Sim in Nice, France
Shuan Sim is a Senior Reporter for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.