Plakous Therapeutics Lands $1.7 Million Fast-Track SBIR Grant
Plakous Therapeutics, a pre-clinical regenerative medicine company based in Winston-Salem, has received a notice from the National Institutes of Health that it is being granted up to $1,725,000 to help it develop a novel therapy targeting a rare disease in premature babies.
Plakous is developing human placenta-derived regenerative therapies, initially focused on Protego-PD, a platform product to treat a devastating and costly disease of premature babies called necrotizing enterocolitis (NEC).
The company’s award is a Phase 1-2 Fast-Track Small Business Innovation Research grant from the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. Plakous’s Chief Scientific Officer Seth Tomblyn, Ph.D., is the principal investigator for the three-year project.
“This grant, combined with our recent orphan drug and rare pediatric disease designations from the FDA, allows Plakous to take the next steps toward preventing NEC, which has no approved treatment or diagnostic tests,” said Plakous CEO Robert Boyce. He added that the grant “validates our scientific and business approach.”
He said the award will fund the potency and preclinical effectiveness milestones for an Investigational New Drug (IND) filing for Protego-PD, an orally delivered acellular biotherapeutic developed by Plakous from post-delivery placentas.
“The grant will complement our currently open $4 million seed round to complete the IND filing requirements,” said Boyce.
NEC is a devastating disease caused by inflammation and lack of development of the intestine. More than 90% of the 6,000 annual cases in the United States occur in very-low-birthweight babies – those born weighing less than three pounds. NEC carries a 30% mortality rate. Managing NEC consumes 20% of hospitals’ $5 billion annual neonatal intensive care unit expenditures, plus an estimated $4 billion in hospital costs for subsequent treatments.
Plakous seeks to prevent NEC with Protego-PD by accelerating intestinal maturation of premature infants.