Aeglea BioTherapeutics, Inc. AGLE announced new positive phase I/II data for pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D), a rare genetic disease. The data showed that pegzilarginase is highly effective in sustainably lowering plasma arginine, which is the primary endpoint in Aeglea’s single, global pivotal phase III PEACE study. Plasma arginine reduction was statistically significant (p<0.001) at eight weeks, with sustained control through longer term dosing.
Further, the new data showed that the marked improvement in plasma arginine control is accompanied by clinically meaningful responses in mobility and adaptive behavior, which are secondary endpoints in the PEACE trial. The treatment was generally well tolerated. Hypersensitivity reactions were infrequent, manageable with standard measures, and did not lead to treatment discontinuation.
Aeglea expects to begin the single, global pivotal phase III PEACE trial in ARG1-D in the second quarter of 2019.
Shares of the company have increased 17.1% in the past year compared with the industry’s growth of 12.1%.
The company is evaluating pegzilarginase in two ongoing clinical studies — one phase I study for the treatment of advanced solid tumors, and a phase I/II combination study of pegzilarginase and Merck’s MRK anti-PD-1 therapy, Keytruda (pembrolizumab) for the treatment of patients with small cell lung cancer (SCLC). After receiving the maximum tolerated dose in the phase Ib combination study, the company advanced pegzilarginase to phase II in December 2018 and dosed the first patient. The company expects to report topline data from open label phase II study in the first half of 2020.
Zacks Rank & Stock to Consider
Aeglea currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth considering are Johnson & Johnson JNJ and Bayer AG BAYRY, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Johnson & Johnson’s earnings per share estimates have increased from $9.20 to $9.21 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters at an average of 1.61%.
Bayer’s earnings per share estimates have increased from $1.92 to $1.95 for 2019 over the past 60 days.
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