Promore Pharma announces that a manufacturing agreement has been entered with APL for the production of investigational medicinal product for its LL-37 Phase IIb trial in patients with hard-to-heal leg ulcers.
The trial will be conducted in Europe with a planned start for patient enrolment in 2018. VLU constitutes the largest category of all chronic, or hard-to-heal, ulcers and represent significant challenges to patients and healthcare systems since they are frequent, costly to manage, recurring, and may persist for months or years. Standard treatment consist of compression bandaging and there are no approved pharmaceutical products for VLUs.
“It is satisfactory to have come so far in our development initiative on LL-37” said Jonas Ekblom, President and CEO of Promore Pharma. “To secure our supply chain of investigational medicinal product for the clinical trial is a key activity and this means we are able to further commit to an ambitious product development schedule. The development has proceeded according to plan and we are very happy about our continued work with APL whom we have learned to know as a high-quality provider of manufacturing services and support”, he continued.
LL-37 is based on a human antimicrobial peptide that stimulates several processes in wound healing. In the Phase IIa study conducted in patients with venous leg ulcers, LL-37 showed good efficacy. The product candidate can be combined with the standard wound care treatments and can be applied by nurses or potentially by the patient alone. The development of LL-37 focuses initially on venous leg ulcers but the company sees good potential in developing LL-37 for also diabetic foot ulcers.