AmideBio, LLC, a privately held biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) Office of Orphan Products Development granted an orphan drug designation to AmideBio’s glucagon analog (ABG-023) for the treatment of congenital hyperinsulinism (CHI). ABG-023 is a solution stable, soluble glucagon analog designed to overcome the limitations of glucagon – an effective treatment for CHI, but rendered impractical for long term administration given its instability in solution. Read the full press release.
AmideBio, LLC, a privately held biopharmaceutical company, announced today that it has received $1.56M in funding through a Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The goal of this two-year grant is to enable an Investigational New Drug (IND) filing with the FDA of a clinical candidate for the long term treatment of congenital hyperinsulinism. Several promising glucagon analogs were identified during the Phase I SBIR, and the Phase II grant will enable the final selection of a clinical candidate and preparation of an IND. Read the full press release.
AmideBio LLC, a privately held biopharmaceutical company, announced today that David Brunel, a board member of AmideBio, has assumed the role of Chairman of the Board, replacing Misha Plam. Dr. Plam, a founder of AmideBio who retired recently as President and CEO, is now Chairman Emeritus. Read the full press release.
AmideBio LLC, a privately held biopharmaceutical company, announced today that Pawel Fludzinski, Ph.D. has assumed the role of Company President in addition to Chief Executive Officer, effective immediately. Dr. Misha Plam is retiring from the role but will remain Chairman of the Board of Directors. Read the full press release.
AmideBio LLC, a privately held biopharmaceutical company, announced today that Dr. Pawel Fludzinski has joined the Company as its new Chief Executive Officer. With his extensive background in the development of drugs targeting diabetes at Eli Lilly & Co, Dr. Fludzinski was selected as the ideal candidate to lead AmideBio’s development of its pipeline of drug candidates targeting metabolic diseases. Read the full press release.
Charles A. Stanley MD joins AmideBio’s scientific advisory board to help further the Company’s soluble glucagon program for treating hyperinsulinism (HI). Dr. Stanley is a world-renowned expert on disorders of insulin regulation in children and founded the Congenital Hyperinsulinism Center at the Children’s Hospital of Philadelphia (CHoP). He helped define the various types of HI and has pioneered best practices for the diagnosis and treatment of congenital HI. Read the full press release.
Dr. Snitman who is a co-founder of Array BioPharma and served as Chief Operating Officer & Vice President, Business Development from 1998 to 2015 has joined AmideBio’s business advisory board. Read the full press release.
AmideBio closed a new private placement round of $764,000 of preferred equity financing. The proceeds will be used to further the development of the Company’s pipeline of improved diabetes drug candidates, with particular focus on soluble glucagon for hyperinsulinism and glucose responsive insulin for diabetes
AMIDEBIO has been awarded a $338,387 Phase 1 SBIR grant from the National Institute of Health to advance the company’s novel glucagon program for treating congenital hyperinsulinism.
AMIDEBIO has been granted European patent protection for novel peptide manufacturing process.