AmideBio Awarded SBIR Phase IIB Grant to Support Pre-Clinical Development of its Long-Acting Stable Glucagon Analog for the Treatment of Hyperinsulinism

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This two-year grant will allow AmideBio to select a long-acting soluble stable glucagon candidate and do the necessary work to support the filing of an Investigational New Drug (IND) application with the FDA at the end of the grant period.

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PR NewswirePR Newswire
Retrieved on: 
Tuesday, October 4, 2022
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MSCE, Birth defect, Hospital, Lists of diseases, IND, National Institute, Investigational New Drug, Biopure, CEO, Population, NIH, Hypoglycemia, Digestive, SBIR, FDA, CHOP, Phase, Brain damage, LLC, Kidney, Program, Child, HI, Division, Congenital hyperinsulinism, Seizure, NIDDK, Company, National Institute of Diabetes and Digestive and Kidney Diseases, Pharmaceutical industry, Diabetes, MD, Endocrinology
Geotags: 
COLORADO
Organisation: 
AMIDEBIO, LLC
Summary
Key Points: 
  • This two-year grant will allow AmideBio to select a long-acting soluble stable glucagon candidate and do the necessary work to support the filing of an Investigational New Drug (IND) application with the FDA at the end of the grant period.
  • In addition, the Company will file for both orphan drug and rare pediatric disease designation with the FDA.
  • Congenital hyperinsulinism is a rare disease that affects newborns and results in persistent hypoglycemia which can lead to serious neurological complications including seizures and brain damage.
  • "We are honored to receive this Phase IIB SBIR grant from the NIH.


AmideBio Awarded SBIR Phase IIB Grant to Support Pre-Clinical Development of its Long-Acting Stable Glucagon Analog for the Treatment of Hyperinsulinism

BOULDER, Colo., Oct. 4, 2022 /PRNewswire/ -- AmideBio, LLC, a privately held biopharmaceutical company, announced today that it has received $2.69M in funding through a Phase IIB Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This two-year grant will allow AmideBio to select a long-acting soluble stable glucagon candidate and do the necessary work to support the filing of an Investigational New Drug (IND) application with the FDA at the end of the grant period. In addition, the Company will file for both orphan drug and rare pediatric disease designation with the FDA.

Congenital hyperinsulinism is a rare disease that affects newborns and results in persistent hypoglycemia which can lead to serious neurological complications including 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 as she did in the Phase 2 SBIR grant. She will undertake the in vivo preclinical testing necessary for the program to progress to the IND stage.

"We are honored to receive this Phase IIB SBIR grant from the NIH. It is an acknowledgement of the strength of the data generated under the Phase II SBIR and the Company's focus on bringing a product to market that truly will meet the needs of these children suffering from HI," said Pawel Fludzinski, CEO and President of AmideBio. "The collaboration with Dr. Diva D. De León-Crutchlow at CHOP, who is a world leader in the treatment of HI, has been pivotal to supporting the continued development of treatment options for this patient population."

About AmideBio:

AmideBio has a pipeline of novel biotherapeutics targeting metabolic diseases. This pipeline was generated by leveraging its core competencies in intelligent design of drug candidates together with its proprietary BioPure™ technology which delivers high purity and difficult-to-manufacture peptides of any length with unprecedented purity for the pharmaceutical and biotech industry.

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SOURCE AmideBio, LLC

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