Frontera Therapeutics Doses First Patient in a Clinical Trial of Gene Therapy for the Treatment of Wet AMD


Frontera Therapeutics recently announced it has dosed the first patient in a clinical trial of its innovative gene therapy product, FT-003, at the Ophthalmology Hospital of Tianjin Medical University in Tianjin, China. FT-003 is being studied for the treatment of neovascular or wet age-related macular degeneration (wAMD) and is Frontera’s second gene therapy product candidate to enter the clinic.

“I am excited by the momentum the Frontera team has achieved so far this year with the dosing of the first patients in two gene therapy Phase 1 clinical trials during the month of January for FT-001 and FT-003,” said Yong Dai, PhD, founder and CEO of Frontera. “FT-003 is designed as a one-time treatment for patients with wet-AMD, a leading cause of blindness globally in people over 60 years old. We remain committed to validating our novel AAV technology platform and to making further breakthroughs in bringing gene therapies to patients with unmet medical needs, and expect to have initial clinical results for both FT-001 and FT-003 later this year.”

Age-Related Macular Degeneration (AMD), also known as Senile Macular Degeneration (SMD), is an irreversible eye disease that leads to severe vision loss or even blindness in the middle-aged and the elderly. AMD is the third most common cause of blindness and the fourth leading cause of visual impairment worldwide. Wet AMD accounts for approximately 10% to 20% of patients with AMD, and is characterized by rapid visual deformation and loss of central vision over weeks to months. The main pathological changes of wet AMD are submacular choroidal neovascularization, vascular leakage, hemorrhage, edema, and finally fibrous scar formation, resulting in progressive impairment of central vision leading to severe blindness.

Frontera Therapeutics is a global, fully-integrated, clinical stage biotechnology company leveraging its novel APEX Technology & Manufacturing platform to develop and manufacture superior and novel gene therapy candidates across multiple disease areas. The platform is an innovative adeno-associated virus (AAV) gene expression system that aims to optimize both new and clinically validated AAV vectors to enhance the safety and efficacy profiles of gene therapy products. The in-house GMP manufacturing capabilities enable rapid production across the product lifecycle, and efficiently advance AAV therapies from research to clinical development. Frontera’s development pipeline spans not only orphan diseases, but also targets large patient markets – including ophthalmology, hematology, cardiovascular, neurology and metabolic diseases. Two of Frontera’s gene therapy product candidates, FT-001 for LCA-2 and FT-003 for wet AMD, have entered clinical development. Frontera Therapeutics has offices in the United States and China, allowing it to target global patient populations. For more information, visit www.fronteratherapeutics.com.