NEWTON, Mass.--(BUSINESS WIRE)--Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company focused on developing and commercializing innovative, non-systemic, oral protein therapeutics to treat metabolic and orphan diseases, today announced that Louis Brenner, M.D., has joined the company as chief operating officer. Dr. Brenner brings to Allena more than a decade of industry leadership experience, including pharmaceutical clinical development strategy, regulatory affairs, business development and marketing. Co-founder and former COO, Robert Gallotto, will remain as a strategic adviser to the company as he transitions to focus more exclusively on his role as president of Alcresta, Inc.
“We are pleased to welcome Lou to the Allena team at this critical time, as we are advancing our Phase 2 program for the management of hyperoxaluria and kidney stones,” said Alexey Margolin, Ph.D., co-founder, president and CEO of Allena Pharmaceuticals. “Lou’s breadth of experience in drug development, regulatory strategy and commercial preparedness, especially in the nephrology space, will be a great asset for us, as we work to accelerate the development of our lead compound, ALLN-177.”
Dr. Brenner joins Allena from Idera Pharmaceuticals, where he served as senior vice president and chief medical officer. He had earlier played key roles in fostering the growth of several biotechnology organizations, including Radius Health, AMAG Pharmaceuticals and the renal and transplantation business units of Genzyme. Dr. Brenner has designed, planned and directed successful clinical trials at all stages and in multiple indications, including managing the late stage development and regulatory submission for Feraheme in patients with chronic kidney disease (CKD). At Radius, he led the conduct of a global Phase 3 trial of a novel candidate for the treatment of osteoporosis. Previously at Genzyme, he led global commercial planning for Renvela in patients with end stage renal disease. Dr. Brenner earned an M.D. from Duke University and an M.B.A. from Harvard Business School. He completed his residency in internal medicine at Brigham and Women’s Hospital and his fellowship in nephrology at Brigham and Women’s Hospital and Massachusetts General Hospital. Dr. Brenner holds a clinical appointment at Brigham and Women’s Hospital.
“Allena is rapidly advancing a novel treatment approach for patients with hyperoxaluria. There are extremely limited options for patients with this difficult condition,” said Dr. Brenner. “The company has demonstrated encouraging clinical results to date, and I am excited for the opportunity to pursue this targeted approach, as we progress ALLN-177 into Phase 2b studies later this year.”
About Hyperoxaluria and ALLN-177
Hyperoxaluria is a condition resulting from high oxalate levels in the urine due to either hyper- absorption of oxalate from the diet (secondary) or from overproduction of oxalate by the liver (primary) due to a genetic defect. Oxalate cannot be further degraded and is primarily excreted by the kidneys. Hyperoxaluria can initially cause the development of kidney stones, and may also lead to kidney damage (nephrocalcinosis), chronic kidney disease, end-stage renal disease and dialysis. There are currently no approved pharmacologic treatments for hyperoxaluria.
ALLN-177 is an orally-administered, recombinant oxalate degrading enzyme in development for the chronic management of hyperoxaluria and kidney stones (nephrolithiasis). ALLN-177 targets oxalate in the gastrointestinal tract, in an effort to reduce the burden of both dietary and endogenously produced oxalate. ALLN-177 has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce the incidence of calcium oxalate related complications. Effective management of hyperoxaluria could reduce long term kidney complications as well as the number of interventions required for the management of kidney stones such as emergency room visits, hospital admissions, extractions and lithotripsy.
Based on positive Phase 2a clinical trial results, Allena is initiating two randomized, placebo-controlled, Phase 2b studies in patients with enteric and idiopathic hyperoxaluria later this year.
About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing non-systemic protein therapeutics to treat metabolic and orphan diseases. Allena’s lead program, ALLN-177, is expected to enter a Phase 2b clinical trial in patients with hyperoxaluria in 2015. The company’s proven approach enables the design and development of oral protein therapies that remain in the gastrointestinal (GI) tract, where the protein exerts its therapeutic effect by reducing toxic metabolites without being absorbed into the bloodstream. Led by a proven management team with deep expertise in protein therapeutic design and development, Allena is committed to bringing breakthrough new treatments to patients with unmet medical needs. Based in Newton, Mass., the company is backed by top-tier venture investors including Frazier Healthcare, Third Rock Ventures, HBM Partners, Bessemer Venture Partners and other investors. For more information, please visit www.allenapharma.com.