CF Foundation Giving Laurent $2 Million to Conduct Phase 2 Trial of Therapy

The Cystic Fibrosis Foundation is giving Laurent Pharmaceuticals $2 million to conduct a Phase 2 clinical trial of Laurent’s cystic fibrosis therapy LAU-7b.

The additional funding comes on top of $3 million that the foundation has already given the company.

“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, Radu Pislariu, the president and chief executive officer of Laurent Pharmaceuticals, said in a press release.

LAU-7b is an oral form of the retinoid fenretinide that Laurent is developing as a treatment for the chronic lung inflammation seen in CF. Traditional anti-inflammatory therapies inhibit the activation of an inflammatory response. LAU-7b uses the body’s own ability to terminate inflammation without interfering with its natural defense mechanisms.

More specifically, LAU-7b works by correcting the defective metabolism of arachidonic acid (AA) and docosahexanoic acid (DHA). These two fatty acids play a key role in maintaining a healthy immune response, and help resolve inflammation.

The aim of the Phase 2 trial (NCT03265288) is to see if LAU-7b can preserve lung function in patients with CF by decreasing inflammation there.

The study has received clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada and is currently in preparation in both countries. The study is not yet recruiting. The enrollment goal is 136 adults with CF, who will be treated for six months.

Participants will have a treatment regimen of six cycles of 21 days each, with drug-free periods of seven days between the cycles. Participants will receive either 300 mg of LAU-7b or a placebo.

In a Phase 1b study (NCT02141958), LAU-7b showed good safety and pharmacokinetic profiles, as well as promise in improving markers of inflammation. The trial included three increasing oral doses of LAU-7b compared to a placebo. Researchers considered a 300-mg dose the safest and best-tolerated.