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Aeglea BioTherapeutics to Present New Interim Phase 1/2 Clinical Trial Data in Arginase 1 Deficiency at 2018 ASHG Annual Meeting

  Company to Host Clinical Update Conference Call on October 17 at 8:30 a.m. ET

Aeglea to Present Literature Review on Arginase 1 Deficiency

Positive Preclinical Efficacy Data on its AEB4104 Homocystinuria Therapeutic Program

AUSTIN, Texas, Oct. 10, 2018 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, today announced it will present new interim Phase 1/2 clinical trial data demonstrating clinical improvement in patients with Arginase 1 Deficiency at the 2018 American Society of Human Genetics (ASHG) Annual Meeting being held October 16 – 20 in San Diego, California. The Company will hold a clinical update conference call on October 17 at 8:30 a.m. ET to discuss these developments.

Title: Improvements in Arginase 1 Deficiency-related disease manifestations following plasma arginine reduction with pegzilarginase: Early phase 2 results

Location/Poster: San Diego Convention Center, Exhibit Hall, Ground Level / #1095

Presentation Date/Time:Wednesday, October 17 at 5:00 p.m.6:00 p.m. ET

In addition, Aeglea BioTherapeutics will present a literature review on Arginase 1 Deficiency and preclinical efficacy data on its homocystinuria therapeutic program:

Title: Clinical features of arginase 1 deficiency: Review of literature case series

Location/Poster: San Diego Convention Center, Exhibit Hall, Ground Level / #1124

Presentation Date/Time: Friday, October 19 at 6:00 p.m.7:00 p.m. ET

Title: Improved survival and amelioration of disease-related liver pathology in a mouse model of homocystinuria with a novel homocysteine degrading enzyme

Location/Poster: San Diego Convention Center, Exhibit Hall, Ground Level / #980

Presentation Date/Time: Friday, October 19 at 6:00 p.m.7:00 p.m. ET

Conference Call & Webcast Details
Aeglea will hold a clinical update conference call on Wednesday, October 17, 2018 at 8:30 a.m. ET. To access the live conference call via phone, please dial 1-877-709-8155 (toll free) within the United States, or 1-201-689-8881 internationally. A replay of the call will be available through October 24, 2018 by dialing 1-877-660-6853 within the United States or 1-201-612-7415 internationally. The conference ID is 13683373.

To access the live and archived webcast of the presentation, please visit the Presentations & Events section of the Aeglea BioTherapeutics investor relations website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

About Pegzilarginase in Arginase 1 Deficiency
Pegzilarginase is an enhanced human arginase that enzymatically depletes the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a rare debilitating disease presenting in childhood with persistent hyperargininemia, severe progressive neurological abnormalities and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. The Company’s interim Phase 1/2 data demonstrated clinical improvements and rapid and sustained lowering of plasma arginine in Arginase 1 Deficiency patients.

About Homocysteinase (AEB4104) in Homocystinuria
AEB4104 is a novel recombinant human enzyme that degrades the amino acid homocysteine and its oxidized form homocystine. Aeglea is developing AEB4104 for the treatment of patients with cystathionine beta synthase (CBS), also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including skeletal abnormalities, cognitive impairment, psychiatric disease, and thromboembolism. AEB4104 is intended to lower the abnormally high blood levels of homocysteine to the normal range in patients with homocystinuria. Preclinical data demonstrated that AEB4104 improved important disease-related abnormalities and survival in a mouse model of homocystinuria.

About Aeglea BioTherapeutics
Aeglea is a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer. Aeglea is developing pegzilarginase, its lead investigational therapy, for the treatment of Arginase 1 Deficiency, as monotherapy in arginine-dependent cancers and in combination with an immune checkpoint inhibitor for small cell lung cancer. In addition, Aeglea has an active research pipeline of other human enzyme-based approaches in both therapeutic areas. For more information, please 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. 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, the potential therapeutic benefits and economic value of our lead product candidate or other product candidates and our eligibility to receive a priority review voucher. 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 June 30, 2018 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.
                              
Media Contact:
David Calusdian
Sharon Merrill Associates
617.542.5300
AGLE@investorrelations.com

Investor Contact:
Joey Perrone
Director, Finance & Investor Relations
Aeglea BioTherapeutics
investors@aegleabio.com

 

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Source: Aeglea BioTherapeutics, Inc.