AUSTIN, Texas, May 23, 2016 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat inborn errors of metabolism and cancer, today announced it received Fast Track Designation from the U.S. Food & Drug Administration (FDA) for its lead investigational molecule, AEB1102, to treat hyperargininemia secondary to Arginase I deficiency.
The FDA’s Fast Track program is designed to facilitate drug development and expedite the review of drugs to treat serious conditions with an unmet medical need, such as hyperargininemia, which results from Arginase I deficiency. The advantages of Fast Track designation include actions to potentially expedite development, including opportunities for frequent interactions with the FDA review team to discuss all aspects of development to support approval and eligibility for accelerated approval and priority review depending on clinical data at the time of a Biologics License Application (BLA) submission. Aeglea is expected to initiate a clinical trial in the U.S. for AEB1102, in patients with Arginase I deficiency, in the first half of 2016.
“We are pleased that after reviewing the seriousness of Arginase I deficiency and the potential of AEB1102, the FDA has granted Fast Track designation for this program,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. “We look forward to working closely with the FDA to facilitate regulatory review as we advance the clinical development and potentially accelerate the delivery of an effective treatment for patients suffering from this devastating disease.”
About AEB1102 to treat Hyperargininemia
Hyperargininemia, or excessively high levels of arginine, is the result of a hereditary deficiency of Arginase I. Arginase I deficiency is a urea cycle disorder caused by a mutation in the Arginase I gene that leads to the inability to degrade arginine, the last step of the urea cycle. It is estimated that 1:350,000 to 1:1,000,000 live births are affected by this disorder, which results in a predisposition to neurologic symptoms including severe intellectual disabilities, seizures and spasticity, and loss of ambulation. AEB1102 is intended to replace the function of Arginase I in patients and return elevated blood arginine levels to the normal physiological range.
About Aeglea BioTherapeutics
Aeglea is a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat inborn errors of metabolism and cancer. The company’s engineered human enzymes are designed to degrade specific amino acids in the blood in order to reduce toxic levels of amino acids in inborn errors of metabolism or to exploit the dependence of certain cancers on specific amino acids. In addition to the ongoing Phase 1 clinical trial in patients with solid tumors in its lead product candidate AEB1102, Aeglea holds effective U.S. INDs for trials of AEB1102 in patients with Arginase I deficiency and in cancer patients with hematological malignancies. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocystine, a target for an inborn error of metabolism, as well as two potential treatments for cancer, AEB3103, which degrades cysteine/cystine, and AEB2109, which degrades methionine.
For more information, visit http://aegleabio.com.
Safe Harbor / Forward Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, statements we make regarding the timing and success of our clinical trials, success in our collaborations and the potential therapeutic benefits and economic value of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 filed with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.