Prometic Life Sciences (TSX:PLI; OTCQX:PFSCF) announced PBI-4050, its orally-active drug candidate PBI-4050, received a Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
As quoted in the press release:
“We are proud to have received a second PIM designation in the UK for PBI-4050, following the designation previously received for Alström syndrome,” said Pierre Laurin, President and Chief Executive Officer of Prometic. “We believe PBI-4050 has the capabilities to address various unmet medical conditions such as IPF and Alström syndrome, for which there are severe limitations with the existing standards of care. We look forward to continuing to collaborate with the MHRA with the goal of advancing both the PBI-4050 IPF and Alström syndrome clinical programs as quickly as possible.”
A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with unmet medical need. The PIM designation is a prerequisite to proceed to the EAMS scientific opinion assessment phase, the second and final step in the EAMS process.