Locilex (pexiganan cream 0.8%) is being developed by Dipexium as an alternative to antibiotics by killing microbial targets through disruption of bacterial cell membrane permeability solely on the area to which it is applied.
The product contains the API 22-amino acid peptide, isolated from the skin of the African Clawed Frog and chemically synthesised, and was acquired from Genaera (formerly Magainin) – a pharma firm which went bankrupt in 2009 – which had suffered from a number of regulatory setbacks due to manufacturing deficiencies in Locilex’s development.
But reporting its end of year financials yesterday, Dipexium said Locilex is progressing well in phase III trials and manufacturing scale-up has put the firm on target for regulatory submissions later this year.
“The company’s manufacturer of active pharmaceutical ingredient [API] has now completed the first of three validation launch of API that we will need for a planned submission of a new drug application amendment to FDA and marketing authorisation application to the European Medicine’s Agency,” CEO David Luci said yesterday (transcript here).
“We’re planning to initiate the manufacture of the two remaining validation lots for regulatory guidelines in the first half of this year.”
He continued, adding the firm has “also scaled up the size of our API lots and have successfully completed the scale up of the first formulated batch of Locilex cream at the 140 kg batch size,” to be used in the upcoming OneStep pivotal phase III trials.
According to the firm’s annual report, the API is produced by Polypeptide Laboratories and the formulation carried out by DPT Laboratories. In all, Dipexium uses three contract manufacturing organisations (CMOs) to produce Locilex, the third being Almac Group, which labels, packages, and delivers the finished goods for clinical trials.
For the full year 2015, operating expenses stood at $18.7m, up 38% year-on-year.