Crushed by PhI­II an­tibi­ot­ic flop, PolyPid says it got FDA sup­port for a come­back — by fo­cus­ing on sub­group

When PolyPid re­vealed its lead pro­gram had flunked the main goal of the first Phase III tri­al, it un­der­scored pos­i­tive re­sults from a sub­group analy­sis. The Is­raeli biotech, which al­ready had an­oth­er Phase III un­der­way, said it would talk to the FDA be­fore de­cid­ing what to do with the sec­ond tri­al.

Al­most five months lat­er, the com­pa­ny says the FDA is keep­ing the doors open for an ap­proval.

PolyPid’s lead can­di­date, D-PLEX100, is a for­mu­la­tion of the an­tibi­ot­ic doxy­cy­cline. On the mol­e­c­u­lar lev­el, it com­pris­es al­ter­nat­ing lay­ers of poly­mers and lipids that en­trap the drug, there­by al­low­ing for a pro­longed and sus­tained re­lease; prac­ti­cal­ly, it’s a paste that can be ap­plied di­rect­ly dur­ing surgery to sur­gi­cal sites to pre­vent in­fec­tions.

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