Laurent Pharmaceuticals Inc. (the “Company”), today announced that it has reached an agreement to receive an additional funding of up to US$ 3 million from the US-based Cystic Fibrosis Foundation (the “Foundation”) to further support its APPLAUD Phase 2 clinical study evaluating the Company’s lead compound LAU-7b in adult patients with cystic fibrosis (CF). This adds to the US$ 5 million development award already made available by the Foundation.
“We are grateful for this additional contribution from the Foundation and the continued support received from the Foundation’s Therapeutic Development Network throughout the course of the ongoing APPLAUD trial”, said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. “At a time when CFTR modulating therapies are being made available to most patients, chronic inflammation is still untreated and the main cause of irreversible lung damage. The interest received from the Foundation and all APPLAUD participants is really motivating for our team, and it conveys a strong message that innovation is ongoing to address the CF disease from every angle.”
LAU-7b is a first-in-class therapy that acts on the resolution phase of the inflammation, with the potential to treat chronic pulmonary inflammation that leads to irreversible lung damage in patients with CF. LAU-7b was also shown to enhance functional CFTR expression in CF airway cells, an effect that was further improved in the presence of a CFTR modulator.
“I am thrilled that Laurent and the Foundation are committed to bringing an anti-inflammatory therapy to the CF community”, said Michael Konstan, MD, Vice Dean for Translational Research at Case Western Reserve University School of Medicine in Cleveland and US Principal Investigator for the study. “The APPLAUD trial is well-designed to provide the necessary information to lead to a Phase 3 trial of this novel therapeutic in patients with CF.”
“It is really exciting to see this strengthened effort for development of anti-inflammatory treatments, so much needed to halt lung destruction associated with CF”, added Larry Lands, MD, PhD, Director, Pediatric Respiratory Medicine at McGill University Health Centre in Montreal and Canadian Principal Investigator for APPLAUD trial. “LAU-7b proposes an interesting treatment approach that uses the body’s own ability to resolve inflammation, which is a more natural way to modulate inflammatory responses without directly interfering with body’s defence mechanisms.”
The goal of the APPLAUD 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 the return to homeostasis. LAU-7b is administered on top of the standard of care, including all commercially available CFTR modulators.
The Phase 2 study is currently enrolling patients in US and Canada, and will start recruiting in Australia by the end of 2019. APPLAUD is planned to enroll 136 adult patients with CF, regardless of their CFTR mutation, for a 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 (oral fenretinide) is a once-a-day 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. More recently, LAU-7b was shown to also enhance specific lipid micro-domains in the membrane of airways cells affected by CF, resulting in an increase in functional CFTR expression under cell stress, a self-protective mechanism that was further improved by co-administration of a CFTR corrector.
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 CF, a critical but still unaddressed pathogenic pathway leading to pulmonary insufficiency in patients with CF. For more information, please visit www.laurentpharma.com.