AGTC Announces Departure of Chief Medical Officer, Company on Track to Announce XLRP and ACHM Data in January 2020
Given that the clinical results for the upcoming data releases are still being processed at external vendors and not yet available for internal review, Dr. Heah’s resignation does not relate to any knowledge of pending results. Dr. Heah has agreed to stay with the company until the end of the year to support the up-coming data analysis.
In addition, Dr. Heah’s departure does not affect the company’s previously announced guidance on the timing of data reporting from its ongoing Phase 1/2 clinical trials in patients with X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM):
AGTC expects to report interim six-month data from the expansion group of its Phase 1/2 XLRP study in
AGTC expects to report interim six-month data from the dose escalation group of both the achromatopsia B3 and A3 Phase 1/2 studies in
“We are on track to present data from our ongoing Phase 1/2 clinical programs in X-linked retinitis pigmentosa and both achromatopsia trials, and continue to advance discussions with the
The Company is exploring options to fill the role of CMO. In the interim, Dr.
Recently, AGTC announced positive data from the ongoing Phase 1/2 trial in patients with X-linked retinitis pigmentosa (XLRP), demonstrating stabilization of decline in the peripheral vision, improvement in central vision, and a favorable safety profile. Based on its ongoing discussion with physicians and advocacy groups, the company expects these results will be highly meaningful to XLRP patients, who today have no treatment options that address the underlying cause of their disease. AGTC also announced positive data demonstrating biological activity in its ongoing Phase 1/2 trials in patients with achromatopsia (ACHM) due to mutations in the ACHM B3 or A3 genes.
AGTC is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases. Its initial focus is in the field of ophthalmology, in which it has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). In addition to its clinical trials, AGTC has preclinical programs in optogenetics, adrenoleukodystrophy (ALD), which is a disease of the central nervous system (CNS) and other CNS, ophthalmology and other indications. The optogenetics program is being developed in collaboration with Bionic Sight. The otology program is being developed in collaboration with
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress and the expected timing thereof, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended
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Source: Applied Genetic Technologies Corporation