Infant Bacterial Therapeutics
IBT is granted Breakthrough Therapy Designation for its Drug Candidate
The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation for IBP-9414’s potential to reduce gastrointestinal-related mortality. A breakthrough designation is intended to facilitate and expedite the development and review of new drugs that address unmet medical needs in treating a serious or life-threatening condition.
Last year, IBT reported the outcomes from “The Connection Study” IBT’s large pivotal Phase 3 trial. The results from the study have been discussed with the FDA, allowing the FDA to conclude, based on their preliminary assessment performed, that IBP-9414 can address unmet medical needs.
“The Breakthrough Therapy designation for IBP-9414 underscores the urgent need for new and effective treatment options for reducing the high rate of mortality and morbidity in very low birthweight (VLBW) premature infants. The designation validates IBT’s pharmaceutical approach to treating the underdeveloped gut, reducing severe conditions like NEC and thereby saving lives. In December 2024, the FDA and IBT agreed that IBT should submit all available clinical data enabling a full review by the FDA of the totality of evidence. IBT is now preparing for the submission in parallel with the activities for the launch of IBP-9414. With the Breakthrough Therapy Designation approved I am very hopeful that full review of the available data leads to an approval. The Breakthrough Therapy Designation from the FDA allows us to collaborate even more closely with the agency to quickly bring IBP-9414 to the market.”, says Staffan Strömberg, CEO of IBT.
| Datum | 2025-03-28, kl 18:52 |
| Källa | MFN |
Investera som eToros bästa investerare! Med eToros CopyTrader™, kan du automatiskt kopiera andra investerares beslut. Hitta investerare som du tror på och kopiera deras investeringar i realtid. Inga extra avgifter tas ut för funktionen.