LocilexSkin and skin structure infections; For mild diabetic foot infection in adults
Development and Regulatory status
Feb 16: company reports that both clinical trials have reached 75% enrolment and are expected to complete by the second half of 2016. Target dates for regulatory submissions are now first half of 2017 for the US and the second half of 2017 for the EU .
Oct 15: DPX-305 and DPX-306 studies have reached 56% and 50% enrolment mark, respectively. Dipexium Pharmaceuticals intends to conduct the DPX-305 and DPX-306 trials simultaneously, and expects to complete enrolment in the trials in 2016 .
Aug 15: OneStep-1 PIII trial has completed 50% enrolment. The Company anticipates completing enrollment and filing a New Drug Application for FDA approval in 2016 .
Dec 14: An NDA submission to the FDA anticipated in the second half of 2015 while a submission to the EMA is targeted during the first half of 2016 under the EMA´s centralised process without the need to conduct European clinical trials. This submission will consist of efficacy results from the OneStep-1 and OneStep-2 pivotal PIII trial programme in the U.S [1,2].
Pexigananis disrupts the lipid bilayer of the negatively charged bacterial cell membrane, leading to bacterial cell lysis. It is active against gram-positive and gram-negative bacteria that commonly infect skin and soft tissue, including MRSA. It has low potential for resistance and no cross-resistance with existing therapeutic antibacterials. The product was originally developed by the Genaera Corporation as pexiganan cream 1% which was denied approval by the FDA. Dipexium Pharmaceuticals modified the formulation and developed 0.8% pexiganan cream. Dipexium Pharmaceuticals now intend to complete phase III development of 0.8% pexiganan cream and re-submit for approval [1,2].
Trial or other data
Oct 16: Dipexium announces two of its PIII programs (OneStep-1 and OneStep-2) missed the primary and secondary endpoints in diabetic foot infections. There were also no meaningful difference in wound closure rate between the Locilex arm and the vehicle arm in each study, and neither trial met the secondary endpoint of gaining a higher rate of eradication of bacteria for the Locilex arm. There was also higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study. Dipexium are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible clinical indications based on an evaluation of all data emerging from the PIII studies .
June 15: Dipexium Pharmaceuticals has received advice from the EMA CHMP with regard to the clinical and regulatory aspects of Dipexium´s planned submission of a Marketing Authorization Application (MAA) for Locilex® for topical treatment of pts with diabetic foot infection (DFI) in the EU .
June 14: Dipexium Pharmaceuticals initiated two simultaneous pivotal, randomised, double-blind, placebo-controlled PIII trials of pexiganan 0.8% cream for the treatment of mildly infected diabetic foot ulcers (OneStep-1; DPX-305; NCT01590758 and OneStep-2; DPX-306; NCT01594762). The treatment was applied twice-daily for 14 days in 180 affected pts in the US. The primary efficacy endpoint is resolution of infection and results are expected during Q2 of 2015 [1,2].