The Government of Quebec, in Canada, has approved a loan of $2.7 million Canadian (about $2.05 million U.S.) to Laurent Pharmaceuticals to help the company conduct a Phase 2 clinical trial to evaluate its investigational oral candidate LAU-7b for the treatment of adults with cystic fibrosis (CF) of any genetic cause.
The loan was given under the BioMed Propulsion Program, an investment fund owned by the Ministry of Economy and Innovation, whose goal is to support life-sciences companies in Quebec. The fund is administered by Investissement Québec.
“We are very pleased with the participation from the Quebec Government through its BioMed Propulsion program,” Radu Pislariu, MD, president and CEO of Laurent Pharmaceuticals, said in a press release.
“The Québec government implemented the BioMed Propulsion program with the goal of supporting companies with high growth potential in Québec’s life sciences sector to help them commercialize their research findings. Of course, one of this program’s objectives is to help patients suffering from diseases such as cystic fibrosis to improve their quality of life and treatment options,” said Pierre Fitzgibbon, Quebec’s minister of economy and innovation.
LAU-7b is an orally available treatment designed to help resolve lung inflammation in people with CF. The therapy consists of an oral form of retinoid fenretinide, a molecule related to vitamin A that is able to correct defects in the metabolism of fatty acids and prompt the resolution of chronic inflammation.
Resolution of inflammation is a new approach that uses the body’s own ability to modulate inflammatory responses to address inflammation without inducing immunosuppression — suppression of the body’s immune system and its ability to fight infections and other diseases.
The investigational therapy was shown to enhance the production of a working CFTR — the protein channel whose deficiency is the root cause of CF — in airway cells. This positive effect was even greater if LAU-7b was combined with a CFTR modulator, an innovative class of CF medicines.
Through such effects, LAU-7b is expected to reduce persistent, unresolved inflammation in the lungs of people with CF, and help them return to a more balanced and healthy state.
“CF is the most common fatal genetic disease affecting Canadian children and adults, with Quebec having prevalence rates that are among the highest in the world,” Pislariu said.
The Phase 2 trial APPLAUD (NCT03265288) will evaluate LAU-7b efficacy and safety, administered with standard-of-care treatments — including all available CFTR modulators — in adult CF patients, regardless of their CFTR mutation.
The goal is to determine if LAU-7b can preserve lung function by reducing persistent inflammation, and improve the lungs’ capacity to defend against resistant bacteria such as Pseudomonas aeruginosa.
Participants will be randomly selected to receive once-daily 300 mg oral capsules of LAU-7b or placebo, for six months. Treatment will consist of six consecutive cycles of 21 days each, spaced by treatment-free periods of one week.
A total of 136 adult patients with CF are expected to be enrolled in the trial. Recruitment is ongoing in the U.S. and Canada, and will start in Australia by the end of 2019. More information about trial contacts and locations is available here.