PHASE 2 STUDY SUPPORTED BY A $1.6M GRANT FROM THE FDA OFFICE OF ORPHAN PRODUCT DEVELOPMENT
Therabron Therapeutics, a privately held clinical stage biopharmaceutical company, today announced that it has initiated the Phase 2 study for its orphan drug, CG100, for the prevention of chronic lung disease in premature infants. This Phase 2 study is supported by a $1.6 M grant from the FDA Office of Orphan Product Development.
The CG100 product consists of recombinant human CC10 protein in a formulation designed for delivery by intratracheal instillation in intubated premature infants with respiratory distress syndrome (RDS).
Over half a million premature infants are born in the US every year. Of those, about 60,000 are very low birthweight (VLBW) and develop RDS and, about 10-15% die. Of those who survive, 10-15,000 will develop neonatal BPD, which is a life-long lung condition that predisposes the child to life-threatening respiratory infections and asthma. These infants typically experience repeated hospitalizations, the need for numerous respiratory medications, and frequent doctor visits throughout infancy and childhood. An estimated $26 billion are spent annually on medical care during the first year of life in these VLBW premature infants and the human cost, in terms of families impacted by having a child with this condition, is enormous. CG100 has the potential to reduce both the human and economic cost of this condition.
Aprile L. Pilon, Ph.D., CEO of Therabron Therapeutics stated: “The initiation of this Phase 2 clinical study is a significant milestone for Therabron Therapeutics. We are very happy to have the opportunity to further evaluate CG100 for the prevention of BPD in premature babies. And we are very fortunate to be able to work with two Boston Hospitals including The Floating Hospital for Children at Tufts Medical Center and Harvard-affiliated Brigham and Women’s Hospital in this study. CG100 could improve the quality of life for these premature babies and their families, and reduce the financial burden of the condition.”
About Therabron Therapeutics (therabron.com)
Based in Rockville, Maryland, CLARASSANCE is a privately-held biopharmaceutical company that develops novel drugs to address the unmet needs in the respiratory market. The Company develops synthetic versions of native human proteins. These proteins are naturally secreted by club cells in the small airways to protect the lining of the respiratory tract. Therabron Therapeutics’s lead product, CC10 protein, has completed two Phase 1 clinical trials; one in adults and one in premature infants. CG100 (infants) is currently in Phase 2 while CG201 (adults) is ready to enter Phase 2 clinical trials for recurrent sinusitis in adults. The Company has three other products at different stages of pre-clinical development. The Company intends to partner its products at early stage, Phase 1 or 2, with the possible exception of CG100 in the US market.
Aprile L. Pilon, CEO
Tel.: +1 (240) 205-7270