On August 9, 2016 Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE), a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare diseases and cancer, reported financial results for the quarter ended June 30, 2016 (Press release, Aeglea BioTherapeutics, AUG 9, 2016, View Source;p=irol-newsArticle&ID=2194025 [SID:1234514453]).
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"We have made significant progress in advancing our AEB1102 clinical program with the initiation of two Phase 1 clinical trials in Arginase I deficiency and hematological malignancies. At the same time, we’ve been working closely with regulatory agencies and are pleased with the momentum we have generated for the AEB1102 program, receiving both Orphan Drug Designation from the European Commission and Fast Track designation from the FDA," said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. "Additionally, we are continuing to make progress in the enrollment of our Phase 1 trial of AEB1102 in patients with advanced solid tumors."
Recent Highlights
Received Orphan Drug Designation for AEB1102 for the treatment of hyperargininemia from the European Commission.
Received Fast Track designation for AEB1102 for the treatment of hyperargininemia secondary to Arginase I deficiency from the U.S. Food & Drug Administration (FDA).
Initiated a Phase 1 clinical trial for the treatment of patients with Arginase I deficiency. Enrollment is anticipated to be completed in 2016 with topline data expected in the first half of 2017.
Initiated a Phase 1 trial of AEB1102 in patients with the hematological malignancies acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Enrollment is expected to be completed in 2017.
Second Quarter 2016 Financial Results
At June 30, 2016, Aeglea had available cash, cash equivalents and marketable securities of $73.6 million. Management believes that Aeglea has sufficient capital resources to fund anticipated operations through the first quarter of 2018.
Aeglea recognized grant revenue of $1.4 million in the second quarter of 2016 compared with $3.4 million in the second quarter of 2015. This grant revenue is the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The decrease was due to grant revenue recognized in connection with the execution of the CPRIT grant agreement in June 2015. Upon execution of the agreement, all accumulated qualified expenditures paid and incurred during the period from June 1, 2014 through June 30, 2015 were recognized as grant revenue in the three months ended June 30, 2015.
Research and development expenses totaled $4.4 million for the second quarter of 2016, compared with $2.7 million for the second quarter of 2015. The increase was primarily associated with the expanded nonclinical and clinical activity for Aeglea’s lead product candidate AEB1102, as Aeglea continued a Phase 1 trial in patients with advanced solid tumors, initiated a Phase 1 clinical trial for AEB1102 in patients with Arginase I deficiency, and prepared for the Phase 1 clinical trial in patients with hematological malignancies.
General and administrative expenses totaled $2.4 million for the second quarter of 2016, compared to $2.1 million in the second quarter of 2015. This increase was primarily due to additional employee compensation and insurance costs associated with being a public company.
Net loss totaled $5.4 million and $1.4 million for the second quarters 2016 and 2015, respectively.
About AEB1102
AEB1102 is a recombinant human arginase I enzyme designed to degrade the amino acid arginine. Aeglea is developing AEB1102 to treat two extremes of arginine metabolism, including arginine excess in patients with Arginase I deficiency, as well as some cancers which have been shown to have a metabolic dependency on arginine. In patients with Arginase I deficiency, AEB1102 is intended for use as Enzyme Replacement Therapy to restore the function of arginase I in patients and return elevated blood arginine levels to the normal physiological range. Aeglea is currently conducting a Phase 1 clinical trial in patients with advanced solid tumors to evaluate the safety and tolerability of AEB1102. Data from this trial demonstrated that AEB1102 has the ability to reduce blood arginine levels, providing initial human proof of mechanism.
About Arginase I deficiency
Hyperargininaemia, 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. AEB1102 is intended to replace the function of arginase I in patients by returning elevated blood arginine levels to the normal physiological range.
About Arginine Dependence in Cancer Cells
Dysregulation of amino acid metabolism has been shown to be a key event in tumor growth and development. Unlike healthy cells, these tumors cells have an abnormally high appetite for certain amino acids and are unable to create their own supply, making them vulnerable to starvation through depletion of that amino acid in the blood. AEB1102 is intended to address an unmet need for these tumor types by degrading arginine in the blood, reducing its level below the normal range to starve the tumor.