Israeli company PolyPid Optimized Therapeutics, which is developing a localized delayed release antibiotic for treatment of bone infections, has announced its acceptance to the US Food and Drug Administration (FDA) Qualified Infectious Disease Program (QIDP). QIDP is a fairly new FDA status for innovative products in the treatment of bacteria resistant to antibiotics.
QIDP status gives a company preference in the FDA testing process and five years of exclusivity in the market independently of patents. PolyPid's product is a combined implant of polymers (plastic) and lipids (fat). When implanted in the bone, it releases the antibiotic gradually and in measured amounts over a prolonged period as a replacement for oral antibiotics or surgery.
The product is about to enter Phase III trials for prevention of post cardiac surgery sternal infections. Such infections are extremely significant following cardiac surgery; the mortality rate among patients who develop them is 40%.
Initial results from a Phase IB/II trial in Israel showed complete prevention of sternal infections among patients treated with the product for three months following surgery.
"The receipt of QIDP designation from the FDA represents an important milestone that expedites and extends the commercial path for D-PLEX in the US,“ says PolyPid CEO Amir Weisberg, "We look forward to the availability of additional data by year-end 2017 from our ongoing Phase Ib/II study in Israel of D-PLEX in post-cardiac surgery sternal infection.”
PolyPid also announced positive interim results from a trial of another product, BonyPid, a synthetic bone substitute that releases antibiotics. The trial involves 64 patients suffering from open shin fractures. Of the 25 first patients treated, the healing time for the fractures was 33% shorter than in the control treatment group given the standard existing treatment.
Published by Globes [online], Israel Business News - www.globes-online.com - on March 13, 2017
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