Mr. Kenneth Galbraith reports
LIMINAL BIOSCIENCES PROVIDES GUIDANCE UPDATE ON CERTAIN EXPECTED KEY MILESTONES FOR 2020
Liminal Biosciences Inc. has provided a guidance update on the timing of certain expected key milestones for 2020.
"While we announced in May the withdrawal of all previously issued guidance on expected key milestones for our business given the uncertainty created by the global COVID-19 pandemic and the priority on the health and safety of our employees during this pandemic, we are continuing to execute and move our business forward, and remain committed to providing further updates on certain key expected milestones, as appropriate." stated Kenneth Galbraith, Chief Executive Officer of Liminal Biosciences. "We now expect the following timing for two important priorities of the Company for 2020:
The re-submission of our biologics licensing application (BLA) with the US Food and Drug Administration (FDA) for Ryplazim (plasminogen) for the treatment of congenital plasminogen deficiency is anticipated to be filed in the third quarter of 2020; and
Our multiple ascending dose (MAD) Phase 1 clinical study of fezagepras is expected to be initiated in the second half of 2020."
About Liminal Biosciences Inc.
Liminal Biosciences is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases related to fibrosis, including respiratory, liver and kidney diseases that have high unmet medical need. Liminal Biosciences has a deep understanding of certain biological targets and pathways that have been implicated in the fibrotic process, including fatty acid receptors such as FFAR1, or GPR40, G-protein-coupled receptor 84, or GPR84, and peroxisome proliferator-activated receptors, or PPARs. In preclinical studies, we observed that targeting these receptors promoted normal tissue regeneration and scar resolution, including preventing the progression of and reversing established fibrosis. We also have encouraging clinical data that we believe supports the translatability of our preclinical data observations to the clinic. We have leveraged this understanding, as well as our experience with generating small molecules, to build a pipeline of differentiated product candidates. Our lead small molecule product candidate, fezagepras (PBI-4050), is expected to enter an additional Phase 1 clinical trial in 2H-2020 to evaluate multiple ascending doses of fezagepras in healthy volunteers, at daily dose exposures higher than those previously evaluated in our completed Phase 1 and Phase 2 clinical trials.
Liminal Biosciences has also leveraged its experience in bioseparation technologies through its subsidiary Prometic Bioproduction Inc. to isolate and purify biopharmaceuticals from human plasma. Our lead plasma-derived product candidate is Ryplazim (plasminogen), for which the Company expects to resubmit a BLA in Q3-2020 with the FDA seeking approval to treat patients with congenital plasminogen deficiency.
Liminal Biosciences has active business operations in Canada, the United Kingdom and the United States.
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