Sweden-based PledPharma has started patient enrolment in Asia for its Phase I SUNCIST clinical trial of drug candidate, PledOx, in healthy volunteers.
PledOx is being developed to prevent chemotherapy-induced peripheral neuropathy in patients suffering from colorectal cancer.
The Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of a single dose of 2-, 5- or 10µmol/kg PledOx in up to 24 Japanese and 24 Caucasian healthy subjects.
Results from the trial are intended to support an expansion of the drug candidate’s global Phase III programme to include Asian patients.
The Phase III programme is scheduled to be launched by the end of this year, while the top-line results are expected to be available in 2020.
PledPharma CEO Nicklas Westerholm said: “The initiation of this first clinical trial in Asian patients provides a kick-start in PledPharma’s and Solasia’s recently announced ambition to develop and commercialise PledOx for the major Asian markets.
“We will work closely with Solasia and local regulatory bodies to facilitate a swift expansion of the Phase III programme, and the data from the now commenced trial will be key during this process.”
PledPharma has signed a licensing agreement with Solasia Pharma granting exclusive development and commercialisation rights to PledOx in Japan, China, Hong Kong, Macau, South Korea, and Taiwan.
As per the agreement, Solasia is set to make upfront, development, regulatory and sales milestones payment of up to $83m and will fully fund the expansion of the Phase III programme.