The trial could prove to be a key development in the treatment of people with the rare inherited condition RP, which currently has no approved cure or standard treatment.
In collaboration with U.S.-based Kiora Pharmaceuticals Inc. and The Royal Adelaide Hospital, leading Australian CRO, Accelagen, today announced that dosing has commenced in the Phase 1 first-in-human trial for KIO-301.
According to a news release, the trial could prove to be a key development in the treatment of people with the rare inherited condition, retinitis pigmentosa (RP), which currently has no approved cure or standard treatment.
"Clinical research is not about just testing something in a group of trial participants. It is about creating measurable improvements for people's health and wellbeing that will impact generations to come," Greg Plunkett, CEO and Founder of Accelagen, said in the news release.
Moreover, Plunkett added that vision is a primary method for humans to make sense of the world around them.
“For those with Retinitis Pigmentosa, losing that ability can be debilitating. We're proud to be partnering with Kiora to launch this trial in Australia," Plunkett said in the news release.
This study - a three-way collaboration between Accelagen, Kiora and The Royal Adelaide Hospital - is a foundational Phase 1b open-label, single ascending dose clinical trial for people living with RP.
As a visible light-sensitive small molecule, KIO-301 acts as a reversible 'photoswitch', specifically designed to restore the eyes' ability to perceive and interpret light in visually impaired patients.
Currently enrolling a small group of RP patients, initial tests are currently being used to determine safety and tolerability of the experimental drug, as well as assessing whether patients have improved vision by evaluating their ability to identify objects, navigate through a mobility course and other ophthalmic and quality-of-life assessments. Also, the study is evaluating how the brain activity changes, specifically looking within the areas of image processing.
Principal Investigator from The Royal Adelaide Hospital in South Australia, Professor Robert Casson, MB BS, has been heavily involved in the program design since inception and shares:
"We believe KIO-301 is capable of restoring meaningful vision in patients living with retinitis pigmentosa, which is a pivotal development for patients,’ Casson said. “The hope is that promising early results may lead to further studies with a wider patient group, and also carry significance for patients with other inherited and/or age-related retinal degeneration."
Demonstrating a big step forward in establishing proof-of-concept for KIO-301, the study's commencement also represents a significant achievement for the clinical trial industry in Australia.
Moreover, Kiora President and CEO Brian M. Stream, PhD, noted that the team has been working with Accelagen for several years.
“We have greatly valued their collaboration and efficiency in moving this trial to action,” he explained in the news release. “Increasingly, Australia is an attractive location for clinical trials for us; we can trust the results we're seeing on account of the world-class healthcare system and research facilities and we have the opportunity to work with experienced and agile CRO's like Accelagen."
Plunkett pointed out that with his company’s infrastructure, diverse population and strong government support for internationally sponsored trials especially in high unmet diseases, trials like this are only going to become more common as pharmaceutical companies and biotechs venture Down Under.
“The fact that innovative international clients like Kiora want to bring their important trials to Australia is a glowing endorsement for our industry and our country," he concluded. “With early positive patient feedback, we look forward to sharing results as additional patients continue to enroll in this study.