- Measures taken to safeguard workforce and continuity of operations
- Recent FDA update on continued efforts to facilitate development of treatments
LAVAL, QC and CAMBRIDGE, UK – March 22, 2020 – Liminal BioSciences Inc. (Nasdaq & TSX: LMNL) (“Liminal BioSciences” or the “Company”), 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, commented today on the impact of the current COVID-19 pandemic on its operations.
“We have been following the rapidly-changing situation with COVID-19 and following the appropriate advice from government agencies with respect our operations. We have taken active steps to ensure continuity in our operations with many of our employees working remotely. For those employees continuing to operate in our production facilities, laboratories, plasma collection centers and administrative offices, as necessary, we have taken reasonable additional precautions and measures”, stated Kenneth Galbraith, Liminal’s Chief Executive Officer. “To date, we are thankfully not aware of any employees stricken with COVID-19, and we have not had any material disruptions to our ongoing business activities – although it is possible that we could be subject to disruptions or delays as the situation evolves.”
Mr. Galbraith added “The current COVID-19 pandemic and our industry’s response is a reminder of the critical importance of innovation in healthcare, and the value of development of new medicines to sustain and improve human health. We at Liminal BioSciences remain committed to advancing our work in discovering, developing and commercializing novel product candidates for patients suffering from diseases related to fibrosis, including respiratory, liver and kidney diseases that have high unmet medical needs.”
“Despite not having internal R&D capabilities in virology or vaccines, we are still evaluating specific ways that we could use our expertise and experience to be helpful to our industry and government response to the COVID-19 pandemic.”
Liminal’s wholly owned subsidiary, Prometic Bioproduction Inc. (PBP) is focused on the development, manufacture and commercialization of Liminal’s lead plasma-derived product candidate, Ryplazim® (plasminogen). We expect to resubmit a Biologics License Application (BLA) for Ryplazim® (plasminogen) for the treatment of patients with congenital plasminogen deficiency with the U.S. Food and Drug Administration (FDA) in the first half of 2020. PBP is focused on bioseparation technologies to isolate and purify biopharmaceuticals from human plasma, with production facilities in Laval, Quebec, plasma collection centres in Canada and the United States and R&D operations in Rockville, Maryland.
On March 19, 2020, the FDA announced that it continues to play a role in facilitating medical countermeasures to treat and prevent COVID-19. In that same announcement, the FDA indicated that there is interest in evaluating whether therapies, such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length, or lessen the severity, of the illness. The FDA further announced that it is taking the lead on an urgent cross-government approach to facilitate the development of these products.
“We are reviewing our own research conducted on plasminogen and other plasma-derived product candidates to determine if there are any further steps that we could be taking towards evaluating the potential benefit to COVID-19 patients,” added Mr. Galbraith. “Given the global healthcare emergency and that these activities are outside our current focus, we expect to coordinate further actions, if any, with other researchers, government departments, regulatory authorities and non-profit agencies, all of whom continue searching in an integrated manner for potentially effective treatments and vaccines.”
About Ryplazim® (plasminogen)
Ryplazim® (plasminogen) is an investigational product candidate based on a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
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 G-protein-coupled receptor 40, or GPR40, and 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 to evaluate multiple ascending doses of fezagepras in healthy volunteers, at dose levels higher than those previously evaluated in our completed Phase 1 and Phase 2 clinical trials. The data from this Phase 1 clinical trial will inform dose selection for future clinical trials of fezagepras, including placebo-controlled, randomized Phase 2 clinical trials in respiratory disease indications such as Idiopathic Pulmonary Fibrosis (IPF) and other Interstitial Lung Diseases (ILDs).
Liminal BioSciences has also leveraged its experience in bioseparation technologies through its wholly owned 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 with the FDA in the first half of 2020 seeking approval to treat patients with congenital plasminogen deficiency.
Liminal BioSciences has active business operations in Canada, the United Kingdom and the United States.
Forward Looking Statement
This press release contains forward-looking statements about Liminal BioSciences’ objectives, strategies and businesses and unaudited financial information that involve risks and uncertainties. Forward‐looking information includes statements concerning, among other things, statements with respect to the timing of any planned BLA resubmission, development of R&D programs, the timing of initiation of clinical trials, the potential impact of COVID-19 on our operations and ongoing business activities and any potential benefit of our product candidates to COVID-19 patients.
These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. At this stage, the product candidates of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include, but are not limited to, Liminal BioSciences’ ability to develop, manufacture, and successfully commercialize product candidates, if ever, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical trials, the ability of Liminal BioSciences’ to take advantage of business opportunities in the pharmaceutical industry, uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals and general changes in economic conditions. You will find a more detailed assessment of these risks, uncertainties and other risks that could cause actual events or results to materially differ from our current expectations in the Company’s Securities and Exchange Commission filings and reports, including in the Annual Report on Form 20-F for the year ended December 31, 2019 and future filings and reports by the Company. As a result, we cannot guarantee that any forward-looking statement will materialize. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. We assume no obligation to update any forward-looking statement contained in this Press Release even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
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