Aura Biosciences announced the dosing of the first patient in a phase 2 study evaluating the safety and efficacy of suprachoroidal (SC) administration of AU-011, the company’s lead product candidate, as a potential first-line treatment for patients with primary choroidal melanoma.
“I am honored to have enrolled the first subject in this exciting trial of AU-011 that, if approved, may offer patients the first targeted therapy that has the potential to not only control tumors but also to preserve vision in the majority of those treated — which could usher in a very beneficial paradigm shift in the management of this challenging disease,” Timothy S. Fuller, MD, from Texas Retina Associates in Dallas, said in a company news release. “In addition, the suprachoroidal injection is a straightforward procedure that ocular oncologists should easily be able to perform.”
The first cohort of this phase 2 study (NCT04417530) demonstrated favorable safety data with no safety findings and no adverse events noted. The objectives of the study include the assessment of safety and preliminary efficacy of the treatment of choroidal melanoma utilizing suprachoroidal administration of AU-011. Other objectives include determining the highest tolerated dosing regimen, as well as assessing immunogenicity.
Carol L. Shields, MD, Director, Ocular Oncology Service at Wills Eye Hospital, Professor of Ophthalmology at Thomas Jefferson University, and lead investigator of the study, commented, “Choroidal melanoma is the most common intraocular cancer in adults and is of grave concern for patients based on its potential to develop into metastatic disease. We are very excited to partner with Aura Biosciences in the launch of this innovative clinical trial on behalf of the patients who need a new first line treatment option for early stage disease, where all current treatments are extremely invasive and result in severe vision loss in many patients. We believe this approach could provide an opportunity for the early treatment of a broader range of patients with this deadly disease.”
“Dosing of the first patient in this phase 2 study is a key milestone for both Aura and the AU-011 development program,” said Cadmus C. Rich, MD, MBA, Chief Medical Officer and Head of R&D for Aura Biosciences, said in the news release. “The suprachoroidal delivery route is compelling because it offers certain potential advantages over intravitreal injection, including higher bioavailability of drug to the posterior segment of the eye where choroidal melanomas are located, and reduced exposure of non-targeted tissues which may lead to an improved safety profile.”