09:20:58 EDT Fri 26 Apr 2024
Enter Symbol
or Name
USA
CA



ProMetic Life Sciences Inc
Symbol PLI
Shares Issued 717,416,263
Close 2018-05-22 C$ 0.81
Market Cap C$ 581,107,173
Recent Sedar Documents

ProMetic's PBI-4050 could stop lung function decline

2018-05-22 13:49 ET - News Release

Mr. Pierre Laurin reports

PROMETIC PRESENTS NEW CLINICAL DATA ON PBI-4050 FOR THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

ProMetic Life Sciences Inc. has made an oral presentation of new clinical data assessing the effect of its lead small-molecule candidate, PBI-4050, on blood biomarkers for the treatment of idiopathic pulmonary fibrosis (IPF) at the American Thoracic Society (ATS) 2018 international conference. Four additional poster presentations on PBI-4050 and the company's lead plasma-derived product candidate, Ryplazim (plasminogen), were also delivered at the conference.

"Our evaluation of the effect of PBI-4050 on blood biomarkers linked to the fibrotic process in IPF patients has shown the positive impact the drug candidate has on anti-fibrotic pathways," said Dr. Lyne Gagnon, PhD, ProMetic's vice-president of research and development (preclinical). "These most recent data demonstrated that PBI-4050 was well tolerated when given alone or in combination with nintedanib or pirfenidone, two marketed IPF treatments. In addition, PBI-4050 given alone, as well as in combination with nintedanib, showed promise in stopping the decline in lung function, something that current treatments have been unable to achieve."

Pierre Laurin, president and chief executive officer of ProMetic, added: "The data generated to date have demonstrated the potential of PBI-4050 in addressing debilitating fibrotic diseases such as IPF. The data presented at this year's ATS conference further enhance our confidence that PBI-4050 and Ryplazim are well positioned to treat the full spectrum of the IPF condition. We look forward to continuing our clinical development of these two promising drug candidates to address the significant unmet needs of patients suffering from IPF."

The oral presentation, titled "Evaluation of the effect of PBI-4050 Alone or in Combination with Pirfenidone or Nintedanib on Blood Biomarkers Linked to the Fibrotic Process in IPF Patients," was presented by Dr. Gagnon. The data presented included:

  • PBI-4050 significantly increased levels of biomarkers known to have anti-fibrotic effects. Following 12 weeks of treatment, PBI-4050 increased the levels of IL-9, known to have anti-fibrotic activity, by 35 per cent (p less than 0.05); IL-7, which acts as a counterregulator to the pro-fibrotic cytokine TGF-s, by 14 per cent (p less than 0.05); and MIP-1s, of which an increase may reflect a change in the balance between a pro-fibrotic and an inflammatory, wound-healing environment, by 11 per cent (p less than 0.05).
  • PBI-4050 positively affected IL-1Ra, which could have a protective role in fibrotic diseases, by 98 per cent (p equal to 0.08).
  • PBI-4050 in combination with nintedanib significantly decreased CCL-18 levels by 10 per cent (p less than 0.01). CCL-18 is a recognized marker of disease severity and elevated levels in serum are associated with a high risk of disease progression.

Patients who responded to PBI-4050 treatment had significantly higher serum plasminogen levels, indicating the importance of plasminogen in IPF.

Key data presented in four additional poster presentations, titled "PBI-4050, a Novel First-in-Class Agent, Improves Hypoxia/Sugen Induced Pulmonary Arterial Hypertension in Rats," "PBI-4050 Therapy Selectively Improves Pulmonary Hypertension, Lung Remodeling and Right Ventricular Function in Heart Failure with Reduced Ejection Fraction," "PBI-4050, a Novel First-in-Class Antifibrotic Agent, Improves Pulmonary Hypertension and Fibrosis, as Well as Right Ventricular Hypertrophy and Fibrosis in Monocrotaline-Treated Rats," and "Plasminogen Reduces Lung Fibrosis in the Bleomycin-Induced Lung Fibrosis Model," included:

  • In a rat model of pulmonary arterial hypertension (PAH), PBI-4050 demonstrated strong efficacy in improving the severity of PAH. PBI-4050 showed a different efficacy profile when compared with standard of care, sildenafil, supporting the possible benefit of combination therapy.
  • In a rat model of pulmonary hypertension (PH), PBI-4050 showed promise as a potential treatment for Group II PH by reducing lung fibrosis and remodelling.
  • In a different rat model of PH, PBI-4050 demonstrated superior efficacy on PH, right ventricular hypertrophy, right ventricle fibrosis and interstitial pulmonary fibrosis, as compared with sildenafil.
  • In a mouse model of pulmonary fibrosis, plasminogen reduced fibrosis and fibrotic markers, demonstrating its potential as a treatment for IPF.

About idiopathic pulmonary fibrosis (IPF) and acute exacerbation

IPF is a chronic, devastating and, ultimately, fatal disease characterized by a progressive decline in lung function. It is a specific type of interstitial lung disease in which the small air sacs of the lung (alveoli) gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). IPF affects approximately 130,000 people in the United States, with about 48,000 new cases diagnosed annually. Nearly 40,000 people with IPF die each year, a mortality rate similar to breast cancer.

About fibrotic process

Fibrosis is characterized by the excessive accumulation of extracellular matrix (ECM) in damaged or inflamed tissues and is the common pathological outcome of many inflammatory and metabolic diseases. Numerous clinical conditions can lead to organ fibrosis and functional failure; in many disorders, acute or persistent inflammation is crucial to trigger the fibrotic response. PBI-4050, a synthetic ligand of GPR40 and GPR84, acts on cells involved in the fibrotic pathway: macrophages, fibroblasts and epithelial cells. Moreover, PBI-4050 reduces fibrosis in animal models of kidney, lung, heart, liver, pancreas and skin fibrosis.

About PBI-4050

PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles demonstrated in a large number of animal models of fibrosis affecting different organs, including the lung, liver, heart, kidney and pancreas. The effects of PBI-4050 demonstrated in animal models have been replicated in phase 2 studies in IPF, in metabolic syndrome with Type 2 diabetes and in Alstrom syndrome. PBI-4050 is entering pivotal placebo-controlled phase 3 clinical trials for the treatment of IPF and has already started placebo-controlled phase 2 trials in metabolic syndrome and Type 2 diabetes patients.

About ProMetic Life Sciences Inc.

ProMetic is a biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs.

The company is headquartered in Laval, Que., Canada, and has research and development facilities in Canada, the United Kingdom and the United States; manufacturing facilities in Canada and the Isle of Man; and corporate and business development activities in Canada, the United States, Europe and Asia.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.