Applied Genetic Technologies Corporation (Nasdaq: AGTC) a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for treatment of rare diseases., announced the presentation of two abstracts at the approaching American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting.
The abstracts establish newer data from the research-stage retinal studies of unique AAV vectors to support clinical phase product release for the X-linked retinitis pigmentosa (XLRP) and enhancement of production process for clinical trials held in the future. The ASGCT Annual Meeting is to be held virtually on May 11-14, 2021
At last check-in after-market trading, shares of Applied Genetic Technologies Corporation (AGTC) were up 3.89% at $4.01. AGTC stock closed last session at $3.86, declining -0.52% or -$0.02. Shares of the company fluctuated between $3.82 and $4.03 throughout the day.AGTC shares have fallen by -3.98% over the last 12 months, and they have moved down by -7.43% in the past week.
About AGTC clinical trials
Data generated among the 28 patients in the XLRP trial comes from six dose groups, which were previously reported in November 200. The data depicts a high safety profile with no dose-limiting inflammatory responses assessed.
In 6 months, the data depicted a rise in mean sensitivity in relation to baseline as observed by microperimetry, and the results were durable through month 12. The most improved corrected visual acuity (BCVA) observations in 20 patients who were centrally dosed at six months shows supportive evidence of enhanced visual acuity between the dose groups, with excessive supportive evidence of adequate improvement in eight out of a total nine patients who were available for observation at month 12.
AGTC has also reported interim data from its currently proceeding Phase 1/2 trials in patients effected with mutations in the ACHMB3 or ACHMA3 gene. Data from the trials demonstrate that the subretinal injection of AGTC has had a high safety review and was well tolerated in one year. Results also show potential refinement in visual sensitivity and light sensitivity in the patients that were identified to depict positive data
AGTC is expected to finish registration of pediatric patients in the two highest dose groups in the ACHMB3 and ACHMA3 trials and intends to follow all the patients for the whole year. The company has revised the study protocol for the trials to permit registration of patients starting from the age of four and to include functional magnetic resonance imaging (fMRI) and enhanced color brightness tests.
Abstract data from retinal stage studies and several clinical trials has shown a positive result and consisted of supportive evidence for improvement in visual activity in the dose groups. Hence investor expectations rose exponentially for the company with AGTC stock price soaring immensely.