PolyActiva commences first Phase I clinical trial with potential to improve lives of millions
August 31, 2018
PolyActiva Pty Ltd, a clinical-stage Australian biotechnology company, has recently recruited first patients into its Phase I clinical study designed to show its glaucoma implant is safe and well tolerated.
PolyActiva has used its proprietary polymer prodrug technology to develop ocular implants that, when placed in the eye, provide sustained treatment over a six-month period, compared to current glaucoma treatment where patients often need to administer four eye drops daily. The revolutionary technology could in the future mean millions of people with open-angle glaucoma no longer need to use daily eye drops.
The potential of removing the reliance on the patient to remember to use eye drops, and the associated difficulty in administering them from the paradigm of glaucoma treatment, is being heralded as major potential health breakthrough by ophthalmologists. Several studies have demonstrated that up to 46 percent of patients have been found not to remember to use their drops or administer them poorly. Failure to adhere to treatment can lead to faster progression of glaucoma, one of the most common causes of blindness.
“This product is designed to make the lives of glaucoma sufferers easier by removing the need for daily drop administration and thus improving treatment management,” says PolyActiva CEO Dr Russell Tait. “The implant is designed to deliver treatment for six months after which it will disappear without further intervention. We’re excited about starting our first clinical study and look forward to seeing how our lead candidate performs.”
Glaucoma is the second leading cause of irreversible blindness globally, affecting 2.7 million Americans and is expected to affect approximately 80 million people worldwide by 2020. In the US, more than 120,000 people are blind from glaucoma, accounting for 9 to 12 percent of all cases of blindness. The global glaucoma market is estimated to be valued at over USD$1 billion.
“The major investors, MRCF and Yuuwa Capital, see this technology having a major potential impact on the lives of millions of glaucoma patients globally,” says Dr Chris Nave, Chairman of PolyActiva and CEO of the Medical Research Commercialisation Fund (MRCF). “This innovative drug delivery technology has further potential applications, such as being used to administer other types of medication, including antibiotics and steroids for cataract surgery patients.”
PolyActiva’s first clinical candidate is designed to provide a constant daily therapeutic dose of latanoprost free acid for at least 26 weeks. Latanoprost is the active ingredient of a commonly prescribed glaucoma eye-drop treatment (Xalatan®).
The clinical trial will assess the safety and tolerance of the implant when administered to glaucoma patients. The implant is also designed to biodegrade within 90 days after the treatment period and is capable of being administered in an ophthalmologist’s office under a slit-lamp using a custom-designed administration device.
One of the lead investigators, renowned ophthalmologist and cataract surgeon, Dr Nathan Kerr says, “PolyActiva’s treatment approach offers significant potential benefits for patients, addressing adherence and improving treatment of this disease. The bespoke administration device is simple to use and intuitive to operate.”
The Phase I clinical trial is being conducted under the Therapeutic Goods Administration Clinical Trial Notification (CTN) scheme at the Royal Victorian Eye and Ear Hospital in Melbourne, Australia, through the Centre of Eye Research Australia (CERA). The Phase I clinical trial will see seven glaucoma patients enrolled to evaluate the safety and tolerability of its PA5108 ocular implant, with initial results expected in Q1 2019.
PolyActiva has secured investment funds to date of USD$11.8m from Australian-based venture capital firms Brandon Capital and Yuuwa Capital.
Further details of the study design can be found on www.anzctr.org.au or www.clinicaltrials.gov