Clinical-stage biotechnology firm Applied Genetic Technologies Corp. (AGTC:NASDAQ), which is engaged in exploring gene therapies for the treatment of rare and inherited diseases, today announced positive interim six-month data from its ongoing Phase 1/2 clinical program in X-linked retinitis pigmentosa (XLRP). The company reported that "the results show that patients treated centrally with its product candidate demonstrated durable improvement in visual function six months after dosing."
The firm claimed that the additional data reinforces previously reported efficacy and safety results and that the updated data will be used in the design and implementation of the company's XLRP pivotal trial that is anticipated to commence by the end of 2020. AGTC stated that it plans to review the data from the XLRP and achromatopsia Phase 1/2 clinical programs at an R&D Day in New York City on January 28, 2020.
The company's President and CEO Sue Washer commented, "These promising results further demonstrate that our XLRP candidate has tremendous potential to provide meaningful benefit to XLRP patients who today have no treatment options...The positive results observed to date give us confidence that the data as a whole will support advancement of our XLRP clinical program to a pivotal trial in 2020."
Dr. Paul Yang, MD, PhD, assistant professor of ophthalmology at the Casey Eye Institute, Oregon Health & Science University in Portland, stated, "The sustained improvement in visual sensitivity in centrally dosed patients are compelling and, if confirmed in a pivotal trial, would be highly meaningful to patients...This is the first investigational therapy for XLRP to report on encouraging improvements in visual acuity. The combination of improved visual function across two endpoints in centrally treated patients and the previously reported stabilization of visual function in peripherally dosed patients, suggest that this gene-based therapy has the potential to be an important new approach to treating XLRP."
The company explained that X-linked Retinitis Pigmentosa (XLRP) "is an inherited condition that causes progressive vision loss in boys and young men. Characteristics of the disease include night blindness in early childhood and progressive constriction of the visual field. In general, XLRP patients experience a gradual decline in visual acuity over the disease course, which results in legal blindness around the 4th decade of life."
Applied Genetic Technologies is a is a clinical-stage biotechnology company headquartered just north of Gainesville in Alachua, Fla., that employs a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare inherited conditions and debilitating diseases. The firm indicates that its initial focus is in the field of ophthalmology and that its most advanced therapy programs are designed to restore visual function and meet the needs of patients with rare blinding conditions. The company has active clinical trials in X-linked retinitis pigmentosa and achromatopsia. AGTC additionally has preclinical programs in optogenetics and other ophthalmology indications and other central nervous system diseases including adrenoleukodystrophy (ALD).
Applied Genetics started off the day with a market capitalization of about $75.8 million with approximately 18.22 million shares outstanding. AGTC shares opened nearly 60% higher today at $6.65 (+$2.49, +59.86%) over yesterday's $4.16 closing price. The stock set a new 52-week high price of $8.80/share in morning trading and has traded today between $5.90 and $8.80 per share on extremely high relative volume. The firm's shares are currently trading at $8.77 (+$4.61, +110.73%).
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