Frontera Therapeutics has announced the dosing of the first subject in a clinical trial of its recombinant adeno-associated virus gene therapy drug, FT-002, to treat X-linked retinitis pigmentosa (XLRP).
FT-002, which is intended for the treatment of patients with XLRP caused by a mutation in the RPGR gene, is the company’s third gene therapy product candidate to enter clinical trials.
Frontera Therapeutics president and chief medical officer Xinyan Li said: “I am very pleased with our speed of execution and the rapid buildup of our medical and clinical operations capabilities. As a company, we now have three gene therapy clinical studies running in parallel.”
The therapy FT-002 is an intraocular injection of a recombinant adeno-associated virus (AAV) carrying the gene that helps repair damaged retinal cell structures and functions and expresses active functional proteins.
One injection of FT-002 is said to delay the progression of the disease or restore the visual function of a patient.
Frontera noted that it is the first AAV gene therapy drug the company is studying in patients with XLRP in China. It is also a potential first-in-class drug.
Frontera Therapeutics founder and CEO Yong Dai said: “FT-002 was manufactured entirely in-house and administered to the first patient as a first-in-class product, again validating the maturity and advancement of the company’s AAV research and development (R&D) platform technology.
“Driven by our mission to develop novel and best-in-class gene therapies, the Frontera team accelerated the R&D process to enable FT-002 to enter the clinic smoothly, and we believe FT-002 could greatly improve the quality of life for XLRP patients for whom there are currently no effective treatments.”
The company hopes to advance additional products into preclinical and clinical trials this year.
Last month, Frontera dosed the first participant in a Phase I clinical trial of FT-001 to treat Leber Congenital Amaurosis-2 (LCA-2).
