Prometic Announces Long Term Clinical Data on Ryplazym

Prometic Life Sciences (TSX:PLI; OTCQX:PFSCF) announced new data from its Phase 2/3 trial of Ryplazym in patients with congenital plasminogen deficiency.
As quoted in the press release:

The data demonstrates that in 10 patients treated with Ryplazym^TM for a total of 48 weeks, there was no recurrence of lesions and no safety or tolerability issues observed related to this longer-term dosing.
Prometic has previously reported data from this pivotal Phase 2/3 trial, which showed that Ryplazym^TM treatment consistently replaced and maintained the plasminogen concentration at an appropriate level and that it resolved all lesions in all 10 patients treated for 12 weeks. These data fulfilled the clinical information required for the Biologics License Application (BLA) filing with the US Food and Drug Administration (FDA) for the Accelerated Regulatory Pathway Approval.  Under the same pivotal Phase 2/3 protocol, these 10 patients have been treated for an additional 36 weeks, for a total drug exposure period of 48 weeks.  In addition to the dossier filed with the FDA, the 48-week clinical efficacy data will form the basis for the upcoming regulatory filing with Health Canada in the fourth quarter of 2017.
“This pivotal Phase 2/3 trial of Ryplazym^TM has successfully met all primary and secondary endpoints, and we are pleased to announce these follow-up results which confirm the durability of the positive clinical efficacy and safety profile out to 48 weeks”, stated John Moran, M.D., Chief Medical Officer of Prometic. “The 48-week clinical data will be submitted as a supplement to our BLA filing, after Ryplazym^TM receives its expected accelerated approval in the fourth quarter of 2017.”

Click here to read the full press release.

Source: www.newswire.ca