Prometic reports first subject dosed in phase I clinical study with single ascending doses of PBI-4547

September 9, 2019
  • Novel, orally active immuno-metabolic agent
  • Potential therapy for NAFLD/NASH, metabolic syndrome and other liver diseases
  • Fully owned and proprietary to Prometic

LAVAL, CANADA, ROCKVILLE, USA and CAMBRIDGE, UK – September 9, 2019 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic), a biopharmaceutical company focused on developing novel therapeutics to treat unmet needs in liver, respiratory, and kidney diseases, announced today that the first subject has been dosed in a Phase I clinical study of PBI-4547. PBI-4547 is a novel, orally active immune-metabolic agent which displays antidiabetic, antihyperlipidemic, anti-inflammatory and anti-fibrotic activity as shown in multiple animal models.

"We are excited to progress our second small molecule anti-fibrotic compound into  clinical studies consistent with our new strategy to focus the cash resources from our strengthened financial position primarily on the development of a portfolio of novel anti-fibrotic compounds in multiple therapeutic categories," said Kenneth Galbraith, Prometic’s Chief Executive Officer, who added, “We continue to make progress on both our discussions with the FDA and EMA in order to commence Phase 3 clinical studies of our lead small molecule compound, PBI-4050, in patients with Alstrom Syndrome, and the filing of our proposed BLA amendment with the FDA for RyplazimTM (plasminogen)”.

The current clinical study is designed to assess the safety, tolerability and pharmacokinetics of single ascending doses of PBI-4547 in healthy subjects (ClinicalTrials.gov Identifier: NCT04068259). A total of 40 adult participants will sequentially receive 1 of 5 doses of PBI-4547 or matching placebo, with each cohort of 8 participants randomized in a 3:1 ratio to receive PBI-4547 or matching placebo. The Phase 1 clinical study is being conducted by the CRO, Syneos, at locations in Quebec City and Montreal, QC, Canada.

Nonalcoholic Steatohepatitis (NASH) is a multi-faceted disease including metabolic dysregulation, chronic inflammation and fibrosis. In relevant animal models, PBI-4547 displays activity against each of these aspects of the disease.

More About PBI-4547

PBI-4547 is part of a novel class compounds discovered by Prometic with primary activity against a group of GPCR’s known as free fatty acid receptors (“FFAR’s”). The target family has a dual mode of action on inflammation and fibrosis. We have observed activity in various inflammatory preclinical models with compounds targeting the class. Prometic is currently evaluating multiple compounds in this class aimed at activity across several fibrotic and inflammatory conditions in respiratory, liver and kidney disease, with a primary focus on orphan conditions.

PBI-4547 is a novel, orally active small molecule that is a GPR84 antagonist, GPR40 (FFAR1)/GPR120 (FFAR4) agonist, and a partial activator of peroxisome proliferator-activated receptors (PPAR). PBI-4547 treatment significantly improved metabolic regulation of glucose and lipids, and reduced hepatic steatosis, ballooning and overall NAFLD (non-alcoholic fatty liver disease) score in high fat diet (HFD)-fed mice. Fatty acid oxidation and expression of mitochondrial uncoupling proteins were increased by PBI-4547 in the liver. Metabolomic profiling demonstrated that the metabolic dysregulation induced by HFD was abolished by PBI-4547. Preclinical studies suggest that PBI-4547 offers the potential as a novel therapy for NAFLD/NASH, metabolic syndrome and other liver diseases.

PBI-4547 is an investigational drug and its safety and efficacy have not yet been established.

For information about the Phase 1 clinical study with PBI-4547: please visit http://www.clinicaltrials.gov.

About Prometic

Prometic (www.prometic.com) is an innovative biopharmaceutical company with a broad pipeline of small molecule therapeutics under development to treat unmet needs in patients with liver, respiratory and kidney disease, with a focus on rare or orphan diseases. Prometic's research involves the study of several G-protein-coupled-receptors, GPR40, GPR120 and GPR84, known as free fatty acid receptors (FFAR’s). These drug candidates have a novel mechanism of action as agonists ("stimulators") of GPR40 and GPR 120, and antagonists ("inhibitors") of GPR84. Our lead drug candidate, PBI-4050, is expected to enter Phase 3 clinical studies for the treatment of Alström Syndrome after approval by the FDA and EMA. A second drug candidate, PBI-4547, is in a Phase 1 clinical study.

Prometic also has leveraged its experience in bioseparation technologies to isolate and purify biopharmaceuticals from human plasma. The lead plasma-derived therapeutic product is RyplazimTM (plasminogen) which the Company expects to file a BLA with the US FDA the first half of 2020 seeking approval to treat patients with congenital plasminogen deficiency. The Company also operates a contract development and manufacturing operation in the United Kingdom, deriving revenue through sales of affinity chromatography media.

Prometic has active business operations in Canada, the United States, Isle of Man and the United Kingdom.

Forward Looking Statements

This presentation contains forward-looking statements about Prometic’s objectives, strategies and businesses that involve risks and uncertainties. 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. Such risks and assumptions include, but are not limited to, Prometic’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Prometic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in the Annual Information Form for the year ended December 31, 2018, under the heading “Risks and Uncertainties related to Prometic’s Business”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement 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. All amounts are in Canadian dollars unless indicated otherwise.

For more information, please visit www.prometic.com.

For further information please contact:

Bruce Pritchard

b.pritchard@prometic.com

+1 450.781.0115

 

Patrick Sartore

p.sartore@prometic.com

+1 450-781-0115

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