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 1 SBIR, and the Phase II grant will enable the final selection of a clinical candidate and preparation of an IND.
Congenital hyperinsulinism is a rare disease that affects newborns and results in persistent hypoglycemia which can lead to serious neurological complications inluding seizures and brain damage. Dr. Diva D. De León-Crutchlow, MD, MSCE, Chief of the Division of Endocrinology and Diabetes and Director of the Congenital Hyperinsulinism Center at Children’s Hospital of Philadelphia (CHOP) will serve as a co-principal investigator on the grant. She is a recognized leader in the treatment of hyperinsulinism and in her role of co-PI, will provide the in vivo preclinical testing necessary for the program to progress to an IND stage.
“We are honored to receive this Phase II SBIR grant from the NIH. It is an acknowledgement of the success of our development under the Phase I SBIR and will allow us to complete our preclinical testing and produce sufficient therapeutic material to move forward with an IND,” said Pawel Fludzinski, CEO and President of AmideBio. “We are delighted to be able to continue to collaborate with Dr. Diva D. De LeónCrutchlow at CHOP who is a world leader in the treatment of CHI and brings significant expertise in the evaluation of potential drug candidates for this tragic disease.”
A solution-stable glucagon may also have potential benefits in the treatment of emergency hypoglycemia, for patients suffering from hypoglycemia after bariatric surgery and in an artificial pancreas for Type 1 and Type 2 diabetes treatment.
AmideBio has a pipeline of novel biotherapeutics generated by leveraging its knowhow to drive intelligent design of drug candidates targeting metabolic diseases. Its proprietary Cap-Clip™ technology delivers high-purity and difficult-to-manufacture BioPure™ peptides of any length with unprecedented purity for the pharmaceutical and biotech industry.