Laurent Pharmaceuticals Awarded $3M to Initiate Phase 2 Study of Oral CF Therapy

The Cystic Fibrosis Foundation Therapeutics (CFFT) recently awarded Laurent Pharmaceuticals a Therapeutics Development Award, valued to up to $3 million, to support a Phase 2 clinical trial evaluating the company’s drug candidate, LAU-7b, as a potential treatment for cystic fibrosis (CF).

“People with CF have an exaggerated and persistent inflammatory response to lung infections, which leads to irreversible lung damage,”  Michael Konstan, MD, vice dean for Translational Research at Case Western Reserve University School of Medicine in Cleveland, Ohio, said in a press release.

“Resolution of inflammation is a new therapeutic approach using the body’s own ability to modulate inflammatory responses, thus addressing inflammation without inducing immunosuppression” said Konstan, who is also vice chair for Clinical Research at UH Rainbow Babies & Children’s Hospital.

LAU-7b is an oral drug designed to address the compromised immune-inflammatory response in CF patients. It is administrated as a once-a-day oral solid dose of fenretinide, a chemical agent with a well-documented safety profile from clinical trials in more than 3,000 adult and pediatric patients.  LAU-7b is designed to correct the defective metabolism and modulate chronic inflammation due to the CF genetic defect.

A Phase 1b dose-ascending study showed that LAU-7b is safe and tolerable in adult CF patients, and a Phase 2 trial also involving adults is now being prepared. This will be performed in collaboration with the Cystic Fibrosis Foundation, a U.S.-based group that is also the largest CF network in the world.

“CFFT is a transformational leader for the CF community and we are honored to become the first Canadian company to receive such an important award. This represents a double recognition for our LAU-7b program, after the investment made by Cystic Fibrosis Canada earlier this year, also a first of its kind,” said Radu Pislariu, MD, president and CEO of Laurent Pharmaceuticals. “We have been working closely with CFFT’s experts in designing of the upcoming Phase 2 study, and we are encouraged by the interest received from the clinical sites and potential investigators.”

Laurent Pharmaceuticals is a clinical stage orphan drug company based in Montréal, Canada.

CF, affecting around 70,000 people worldwide, is a serious genetic disorder characterized by severe pulmonary dysfunction that leads to inflamed airways. Although the management of CF has significantly improved over the past 70 years, new and better therapeutic agents are needed.