Laurent Pharmaceuticals Inc. (the “Company”), today announced that it has reached an agreement to receive an additional US$ 2 million commitment from US-based Cystic Fibrosis Foundation to further support the upcoming Phase 2 clinical study aimed at demonstrating the safety and efficacy of the Company’s lead compound LAU-7b in adult patients with cystic fibrosis (CF). This new award is in addition to the US$ 3 million development award already committed by the CF Foundation to the Company.
LAU-7b is a once-a-day oral pro-resolving therapy with potential to treat chronic pulmonary inflammation that leads to irreversible lung damage in patients with CF, regardless of their CFTR genotype. As opposed to typical anti-inflammatory drugs that inhibit the activation of the inflammatory response, LAU-7b uses the body’s own ability to timely terminate inflammation without interfering with the natural defense mechanisms.
“We are truly grateful for this additional support from Cystic Fibrosis Foundation. This will enable us to advance the LAU-7b treatment paradigm for patients with CF, and we are encouraged by the interest received from the foundation, the clinical sites and investigators to contribute and participate in this Phase 2 study”, said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals.
LAU-7b was tested in adults with CF in a dose-ascending Phase 1b study, showing good safety and pharmacokinetic profiles, coupled with promising positive effects on specific markers of inflammation.
The goal of the upcoming Phase 2 trial is to evaluate LAU-7b’s effect on the preservation of lung function in patients with CF, by reducing persistent unresolved inflammation in the lung and stimulating its return to homeostasis. The Phase 2 study received clearance from both the US FDA and Health Canada and is currently in advanced preparation in both countries. The study will enroll 136 adults with CF for treatment duration of 6 months.
About Cystic Fibrosis
Cystic Fibrosis (“CF”) is a progressive, life-threatening, genetic disease affecting about 75,000 people worldwide. CF is caused by various mutations in the CFTR gene and is characterized by viscous secretions in different exocrine tissues and an aberrant inflammatory response leading to chronic pulmonary infection and loss in lung function over time. Severe pulmonary dysfunction is the primary cause of death in CF.
LAU-7b (fenretinide) is a once-a-day oral pro-resolving therapy, a new class of drugs specifically designed to trigger the resolution phase of inflammation, which is responsible for healing and return to homeostasis after a bacterial attack or injury. LAU-7b works by endogenously modulating the metabolism of docosahexaenoic acid (DHA), an essential fatty acid involved in the resolution of inflammation. Previous preclinical work at McGill University demonstrated the ability of fenretinide to restore DHA in a specific animal model of CF, resulting in reduced lung inflammation and increased clearance of pulmonary infection with Pseudomonas aeruginosa, a bacterium involved in perpetuating the vicious cycle of inflammation-infection. In the same animal model, fenretinide has also shown potential in preventing the early onset of CF-related osteoporosis, an increasingly prevalent co-morbidity in patients with CF.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a Canada-based clinical stage company focusing on rare inflammatory diseases. Laurent’s lead drug candidate, LAU-7b, is a Phase 2 ready oral drug addressing the compromised immune-inflammatory response in cystic fibrosis, a critical but still unaddressed pathogenic pathway leading to pulmonary insufficiency in patients with CF. For more information, please visit www.laurentpharma.com.