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Israeli PolyPid Ready for Clinical Trials of Anti-Infective Surgical Products
March 4, 2016
PolyPid expects to use a $22 million cash infusion to get its surgical drug reservoir lead candidate into Phase III testing, while completing a trial for its doxycycline-loaded synthetic bone substitute. The latter, for BonyPid-1000, is expected to be sufficient to gain a CE mark by next year.
BonyPid-1000 is expected to offer an alternative for patients with severe open tibia fractures who are highly prone to infection at the fracture site, which can lead to several subsequent surgical inventions and are associated with longer healing time and higher amputation rates. The bone graft substitute contains broad-spectrum antibiotic doxycycline hyclate, which is released over four weeks.
The trial started in December; it is a randomized, single-blind, standard-of-care-controlled study. It’s expected to enroll 64 patients with severe open tibia fractures at 5 sites in Israel and three in Asia. The primary endpoint of the study is performance and safety of BonyPid-1000 on bone healing in traumatic open fracture patients over 6 and 12 months as compared with standard of care.
In pilot testing in the open fracture indication, there were no infections in the target fracture and no amputations after 6 to 12 months of follow-up.
The company’s lead product is D-Plex, an antibiotic drug reservoir that’s intended to be administered after surgical procedures and release the entrapped antibiotic over the course of several weeks, thereby reducing the incidence of infection. The Phase III trial will be to prevent post-cardiac surgery sternal infections, of which it said about 40% are fatal.
The financing was co-led by new investor Shavit Capital, a late-stage Israeli investor with $125 million under management, and existing investor Aurum Ventures. It also included participation from Chaim Hurvitz, who is the son of former Teva ($TEVA) CEO Eli Hurvitz, who now will head its board, as well as other existing shareholders. The fundraising comes after a pair of failed IPO attempts in 2014 and 2015.
“The commitment from both new and existing investors provides us with the necessary resources to advance our pipeline towards commercialization, initiate our own GMP manufacturing facility and further invest in early-stage PLEX programs that can fuel our growth over the long term in the area of post-surgery infections and pain management,” said PolyPid CEO Amir Weisberg in a statement. “With this financing in place, we are well positioned to advance our drug candidates that address unmet medical needs in post-surgical care.”