Putting Australian clinical research on the map globally, comes the ground-breaking first-in-human clinical trial for KIO-301.

15 February 2023 | Wednesday | News

Groundbreaking clinical trial underway to improve vision in individuals with advanced Retinitis Pigmentosa (RP)
Image Source : Public Domain

Image Source : Public Domain

 In collaboration with US-based Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) and The Royal Adelaide Hospital, leading Australian CRO, Accelagen, is proud to announce that dosing has commenced in the Phase 1 first-in-human trial for KIO-301.

This trial represents a remarkable development in the treatment of people with the rare inherited condition, Retinitis Pigmentosa (RP), which currently has no approved cure or standard treatment.

Always at the forefront of full service pharmaceutical and medical device development worldwide, Accelagen's work is first and foremost about accelerating and improving the future of human health:

"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," shares Greg Plunkett, CEO and Founder of Accelagen.

"Vision is one of key ways that we, as humans, make sense of the world around us. 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 continues.

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.

RP is a rare, inherited genetic eye disease that creates significant loss of functional vision and degeneration of the retinal photoreceptors (rods and cones). Affecting approximately 1 in 4,000 people or 1.5 million people worldwide, those diagnosed are typically born with it, and the majority eventually lose most or all of their vision.  

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 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. 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.

President and Chief Executive Officer of Kiora, Brian M. Strem, Ph.D. shared:

"Members of our team have been working with Accelagen for several years. We have greatly valued their collaboration and efficiency in moving this trial to action. 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."

Accelagen founder and CEO, Greg Plunkett, concurs, adding:

"With our state-of-the-art 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.


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