Wed, 29 Mar 2023

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

MELBOURNE, Australia, Feb. 15, 2023 /PRNewswire/ -- 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.

With early positive patient feedback, we look forward to sharing results as additional patients continue to enrol in this ground-breaking study.

For more information, images or interview requests, please contact:

Nicole Kanellopoulos/ Remy Arena @ Mkt. Communications

0474 305 140  /  0421 642 487

Email: accelagen@mktcommunications.com.au

About Accelagen

Accelagen is a leading Contract Research Organisation (CRO) that works with innovative clients both in Australia and across the globe, employing a unique approach to process and people to co-create meaningful outcomes that have a tangible impact on the future of human health and wellness.

Accelagen is underpinned by the desire and courage to do things differently. Guided by purpose, the company continues to attract like-minded experts who share this desire and who won't settle for the status quo. By bringing attention to the human side of what can be a very clinical field, Accelagen leads the way in using data and research to solve social and environmental issues that will change the world.

About Kiora Pharmaceuticals

Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercialising products for the treatment of ophthalmic diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-101 is being developed for the treatment of the Ocular Presentation of Rheumatoid Arthritis ("OPRA"). It is a next-generation, non-steroidal, immuno-modulatory and small molecule inhibitor of Dihydroorotate Dehydrogenase ("DHODH") with what Kiora believes is best-in-class picomolar potency and a validated immune modulating mechanism (blocks T cell proliferation and proinflammatory cytokine release) designed to overcome the off-target side effects and safety issues associated with commercially available DHODH inhibitors. In addition, Kiora is developing KIO-201, a chemically cross-linked form of the natural polymer hyaluronic acid, designed to accelerate corneal wound healing. In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts.

Forward-Looking Statements

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbour provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, completing enrollment in planned clinical studies, including the ABACUS study, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-101, KIO-201 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Amendment No. 1 to Annual Report on Form 10-K/A filed with the SEC on July 7, 2022 or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.

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