News

Frontera Therapeutics’ FT-002 Achieves Orphan Drug Designation from the U.S. FDA for Inherited Retinal Dystrophies

BEDFORD, Mass., and Suzhou, China, January 23, 2024 — Frontera Therapeutics announces that its pioneering AAV gene therapy product, FT-002, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of Inherited Retinal Dystrophies (IRD) caused by RPGR gene variants. About Orphan Drug Designation Orphan Drug Designation, granted …

Frontera Therapeutics’ FT-002 Achieves Orphan Drug Designation from the U.S. FDA for Inherited Retinal Dystrophies Read More »

Preliminary Clinical Study Results of Frontera Therapeutics FT-002 Injection Presented at APVRS Congress

Hongkong, China, Decemeber 8th, 2023 – Preliminary clinical study results of FT-002, an AAV gene therapy treatment of Frontera Therapeutics, a potential first in class therapy for the treatment of XLRP, were reported at the 16th Asia-Pacific Vitreo-Retina Society, APVRS, 2023). Professor Sui Ruifang from Peking Union Medical College Hospital was invited to participate in …

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Frontera Therapeutics Initiates Phase II Clinical Trial for FT-001 in Hereditary Retinopathy Treatment

Beijing, China, Decemeber 3rd, 2023 – Frontera Therapeutics (Suzhou) Co., Ltd. (hereinafter referred to as Frontera Therapeutics) convened a meeting in Beijing on December 3 to conclude the Phase I clinical study of FT-001, and initiate the Phase II clinical study. The meeting was attended by esteemed clinical experts, including Professor Sui Ruifang, Professor Yu …

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Frontera Therapeutics announces CDE clearance to initiate clinical trial of a First-in-class gene therapy for the treatment of RPGR-associated X-linked Retinitis Pigmentosa

BEDFORD, Mass., and SHANGHAI, China, Nov 6th, 2023 – Frontera Therapeutics (Suzhou) Co., Ltd (referred to as Frontera) announced the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has given clearance of the Investigational New Drug (IND) application to begin a clinical trial of an innovative gene therapy drug, FT-002, for …

Frontera Therapeutics announces CDE clearance to initiate clinical trial of a First-in-class gene therapy for the treatment of RPGR-associated X-linked Retinitis Pigmentosa Read More »

The Frontera’s third gene therapy treatment has been approved by CDE for clinical studies

BEDFORD, Mass., and SHANGHAI, China, July 12, 2023 – An application for an investigational study in human patients with FT-004, an innovative gene therapy drug independently developed by Frontera Biotechnology (Suzhou) Co., Ltd. (hereinafter referred to as “Frontera Biotechnology”), was approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration for …

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A first in China – Frontera Therapeutics Doses First Patient in a Clinical Trial of FT-003 Gene Therapy for the Treatment of DME

BEDFORD, Mass., and SHANGHAI, China, June 13th 2023 – Frontera Therapeutics announced another major clinical milestone: FT-003 was successfully dosed for the first patient with Diabetic Macular Edema (DME) in the Ophthalmic Hospital of Tianjin Medical University. This marks the first treatment of gene therapy  for this indication in China. Read the original article Li …

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Frontera Therapeutics Doses First Patient in a Trial of FT-002 Gene Therapy for the Treatment of X-Linked Retinitis Pigmentosa

Three of Frontera’s gene therapy product candidates have entered clinical trials since the beginning of 2023 BEDFORD, Mass., and SHANGHAI, China, February 16, 2023 — Frontera Therapeutics, a global clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of patients across multiple disease areas, announced that it …

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Frontera Therapeutics Doses First Patient in a Clinical Trial of FT-003 Gene Therapy for the Treatment of Wet AMD

BEDFORD, Mass., and SHANGHAI, China, February 2, 2023 – Frontera Therapeutics, a global clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of patients across multiple disease areas, announced that it has dosed the first patient in a clinical trial of its innovative gene therapy product, FT-003, …

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Frontera Therapeutics Doses First Patient in Phase 1 Clinical Trial for Gene Therapy FT-001 for the Treatment of Leber Congenital Amaurosis-2

BEDFORD, Mass., and SHANGHAI, China, January 6, 2023 — Frontera Therapeutics, a global clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of patients across multiple disease areas, today announced that it has dosed the first patient in a Phase 1 clinical trial of its lead gene …

Frontera Therapeutics Doses First Patient in Phase 1 Clinical Trial for Gene Therapy FT-001 for the Treatment of Leber Congenital Amaurosis-2 Read More »

Frontera Therapeutics Receives Additional IND Clearance for its Lead Program FT-001

China CDE accepts Investigational New Drug (IND) application for lead gene therapy product candidate, FT-001, for the treatment of a rare inherited eye disease. BEDFORD, Massachusetts, and SHANGHAI, China September 21, 2022 — Frontera Therapeutics, a global clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of …

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