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Find Clinical Drug Pipeline Developments & Deals by Agtc
On closing, AGTC will be Syncona’s third company focused on retinal gene therapy, and transitioning AGTC-501 to Syncona’s experienced stewardship with the goal of advancing this differentiated product candidate to patients with XLRP.
AGTC intends to use the net proceeds from this offering, to fund its ongoing Skyline and Vista clinical trials in its X-linked retinitis pigmentosa (XLRP) program, AGTC-501 (rAAV2tYF-GRK1-hRPGRco) and its ongoing Phase 1/2 clinical trials in its Achromatopsia program.
AGTC-501, recombinant AAV viral vector-based gene therapy targeting mutations in RPGR gene in patients with X-linked retinitis pigmentosa, demonstrated 62.5% of patients in dose group B were responders for improvements in visual sensitivity, study’s primary efficacy endpoint.
18 months after treatment, of eyes in study with visible foveal EZ at baseline underwent subretinal administration of AGTC-501 (rAAV2tYF-GRK1-hRPGRco), showed recovery of foveal EZ and nearly half had improved EZ appearance, correlated with improvement in macular sensitivity.
Administration of AVrh10-Based Gene Therapy, in non-human primates resulted in a dose-dependent and sustained expression of human progranulin in cerebrospinal fluid and achieved levels above physiological level in normal humans, without any vector-associated adverse effects.
AGTC-401, a recombinant AAV viral vector-based gene therapy targeting mutations in the CNGB3 gene in patients with achromatopsia demonstrated a favorable safety profile through second-highest dose (1.1E+12 vg/mL) in ACHMB3 pediatric patients.
AGTC intends to use the net proceeds from this offering, together with other available funds, to fund its ongoing Skyline and Vista clinical trials in its X-linked retinitis pigmentosa (XLRP) program and its ongoing Phase 1/2 clinical trials in its Achromatopsia program.
SKYLINE Trial of AGTC-501 (rAAV2tYF-GRK1-hRPGRco), on track to report three-month interim study results, including visual acuity, visual sensitivity, mobility and safety data, in Q2 2022 for the treatment of X-linked retinitis pigmentosa.
Adeno-associated virus (AAV)-based gene therapies for the treatment of rare inherited retinal diseases (IRDs), particularly dry-age related macular degeneration (AMD), including the relevance of expressing complement factor H as a therapeutic approach.
Adeno-associated virus (AAV)-based gene therapies, subretinal gene therapy used for treatment of Achromatopsia, and AGTC-501 for X-Linked Retinitis Pigmentosa.
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