MONTREAL, QC, Canada – April 8th, 2021
- Announces Positive Outcome of Pre-Planned Interim DSMB Safety Review and Futility Analysis for Phase 2 RESOLUTION Study in Hospitalized COVID-19 Patients
- Completes Enrollment in Phase 2 APPLAUD Study in Patients with Cystic Fibrosis
- Topline Results Expected in H2 2021 for both RESOLUTION and APPLAUD Studies
Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing first-in-class pro-resolving drug LAU-7b, today announces that the independent Data Safety Monitoring Board (DSMB) for the Phase 2 RESOLUTION study in hospitalized patients with COVID-19 unanimously recommended to continue the study without modification following a pre-scheduled safety review and mid-study interim futility analysis of unblinded efficacy data from the first 102 patients treated in the study. The company also reports the completion of enrollment in its Phase 2 APPLAUD study in adult patients with Cystic Fibrosis (CF).
“We are thrilled to have met these important milestones confirming we are heading in the right direction, with both studies expecting topline results in the second half of 2021,” said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. “Despite the difficulties caused by the pandemic, we continued our lead clinical program in CF, started a new Phase 2 trial in COVID-19 and scaled-up manufacturing for Phase 3 clinical development, while securing sufficient funding for current operations through 2022. All in all, it was an exciting year of clinical advancement for the company and we cannot be more grateful for the support received from our investors, US CF Foundation, and both Canada and Quebec governments.”
LAU-7b is a novel oral form of fenretinide, an atypical retinoid that acts on fatty acid desaturases to modulate key membrane lipids that play central roles in inflammation and the immune defense. LAU-7b was initially developed for its potential to trigger the resolution phase of inflammation, a natural mechanism that keeps the inflammatory response under control, without inducing immune-suppression (a “pro-resolving” effect). More recently, fenretinide was shown to have antiviral activity in vitro against SARS-CoV-2 and synergistic potential when combined with remdesivir, evocative of different mechanism than typical antivirals.
"With viral mutations increasing uncertainty around coronavirus persistence and seasonality, the need for effective therapeutics against COVID-19 disease is more important than ever,” continued Dr. Pislariu. “Because fenretinide targets the human host cell membrane lipids involved in both viral replication and immune-inflammatory responses, its activity is expected to be maintained regardless of the coronavirus variants and be complementary to virus-specific antivirals such as remdesivir. LAU-7b has a well-established safety profile, a convenient once-a-day oral administration, and potential for a dual antiviral and inflammation-controlling mechanism of action, which bears the promise of a treatment candidate addressing multiple key contributors to the severity of COVID-19.”
About Phase 2 RESOLUTION trial
RESOLUTION is placebo-controlled Phase 2 trial with LAU-7b as a potential treatment against COVID-19 disease, aiming to demonstrate that LAU-7b is a safe and effective treatment option for hospitalized COVID-19 patients that are at risk of lung complications because of their age, underlying conditions or both. The study is expected to enroll 220 in hospitals across the United States and Canada, for a treatment duration of 14 days. RESOLUTION, which follows the FDA and WHO recommendations, will measure the disease progression on a 7-point ordinal scale to inform the primary and secondary endpoints of the study. The study also evaluates the duration of hospitalization and improvement in quality of life. More details about the study can be found on www.clinicaltrials.gov (#NCT04417257).
About Phase 2 APPLAUD trial
APPLAUD is a placebo-controlled Phase 2 study of the efficacy and safety of LAU-7b in the treatment of Cystic Fibrosis in adults, aiming to evaluate LAU-7b’s effect on the resolution of inflammation and preservation of lung function. A number of 166 patients were enrolled at hospital sites across Canada, the United States and Australia, for a treatment duration of 6 months. The study measures the lung function at 24 weeks, pulmonary exacerbations, quality of life, Pseudomonas aeruginosa infection level, systemic inflammatory and lipidomic biomarkers. More details about the study can be found on www.clinicaltrials.gov (#NCT03265288).
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on life-threatening inflammatory and fibrotic diseases. The company’s lead drug candidate, LAU-7b, is a unique, patent-protected oral formulation of fenretinide, ideally applicable to a once-a-day low-dose treatment regimen. Fenretinide is an investigational retinoid that has a well-documented safety profile established in more than 3,000 patients, in various indications. LAU-7b is currently being evaluated in two Phase 2 clinical trials, in Cystic Fibrosis and COVID-19. For more information, please visit www.laurentpharma.com.
Laurent Pharmaceuticals Inc.