ProMetic Life Sciences has announced that its orally active lead drug candidate, PBI-4050, has been issued a Promising Innovative Medicine (“PIM”) designation by the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) for the treatment of Alström Syndrome (“AS”).
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 the potential to address an unmet medical need following an early review of the clinical data by the agency.
Such a designation is a prerequisite to enter the EAMS scientific opinion assessment step.
Dr John Moran, ProMetic’s chief medical officer, commented on the PIM designation “We are very proud to have received the PIM designation. We are pleased to see the MHRA agree that the data generated so far with PBI-4050 in the Alström Syndrome phase 2 clinical trial demonstrates that it has the potential to address this very serious and debilitating medical condition for which there is basically no complete medical solution available at the moment”.
The EAMS provides an opportunity for important drugs to be used in UK clinical practice in parallel with the later stages of the regulatory process. It is anticipated that medicines with a positive EAMS opinion could be commercially made available to patients 12 – 18 months before receiving marketing authorisation.
Pierre Laurin, president and chief executive officer of ProMetic stated “We are very enthusiastic for patients afflicted with this disease with MHRA’s decision. We believe PBI-4050 to have first-in-class anti-fibrotic properties and look forward to continue working closely with the MHRA to advance PBI-4050 through its clinical program and provide Alström Syndrome patients with a new treatment option as soon as possible.”
The PIM designation follows the recent grant of an orphan drug designation status for the treatment of Alström Syndrome by the European Commission.
ProMetic Life Sciences is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs.