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Applied Genetic Technologies Announces Enrollments in Phase 1/2 Clinical Trials
Apr. 08, 2019 09:57AM PST
Biotech InvestingApplied Genetic Technologies (NASDAQ:AGTC) has announced it has reached two milestones in two of its Phase 1/2 clinical trials. As quoted in the press release: The company completed enrollment of the dose escalation portion of the achromatopsia (ACHM) CNGB3 trial, which is evaluating the safety and efficacy of its product candidate (rAAV2tYF-PR1.7-hCNGB3) for the treatment …
Applied Genetic Technologies (NASDAQ:AGTC) has announced it has reached two milestones in two of its Phase 1/2 clinical trials.
As quoted in the press release:
The company completed enrollment of the dose escalation portion of the achromatopsia (ACHM) CNGB3 trial, which is evaluating the safety and efficacy of its product candidate (rAAV2tYF-PR1.7-hCNGB3) for the treatment of ACHM caused by mutations in the CNGB3 gene. The company also completed enrollment in the expansion group, which includes pediatric patients, of its product candidate (rAAV2tYF-GRK1-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene. Both investigational therapies utilize the company’s proprietary AAV delivery technology and are administered by subretinal injection.
“Continued success enrolling in all our clinical trials is critical to advancing new and innovative gene therapies for patients with inherited retinal diseases that lack approved treatment options and we are pleased with the progress we have made,” said Sue Washer, president and CEO of AGTC. “Achieving these important milestones is a testament to the dedication of the AGTC clinical teams and our clinical investigators, underscoring the support that our investigational therapies have among the patient communities we seek to serve.”
The company is enrolling patients in two parallel Phase 1/2 clinical trials of its product candidates for ACHM caused by mutations in the two most common ACHM genes, CNGB3 and CNGA3. To date, AGTC has enrolled 12 patients in the ACHM CNGB3 trial and six patients in the ACHM CNGA3 trial. AGTC plans to provide topline interim six-month data for the dose escalation portion of the CNGB3 study in the second half of 2019. To date, AGTC has completed enrollment of 10 and six patients in the dose escalation and expansion portions of the XLRP trial, respectively. The company plans to provide topline interim six-month data for the dose escalation portion of the trial in the third quarter of 2019 and the expansion portion in the fourth quarter.