Committed to developing treatments
for complex degenerative conditions with high unmet needs.
Laurent Pharma capitalizes on 10+ years of clinical development with LAU-7b in respiratory diseases.
Preserving lung function.
Cystic fibrosis (CF)
Lung inflammation is associated with tissue damage in cystic fibrosis. LAU-7b was shown to control inflammation and stabilize CFTR protein in the epithelial membrane during inflammatory stress in preclinical models of CF, via a therapeutic approach that appears to be complementary to CFTR modulators.
A double-blind, randomized, placebo-controlled Phase 2 study was conducted to evaluate efficacy and safety of LAU-7b in adults with CF. LAU-7b or placebo was administered over 24 weeks as six 21-day treatment cycles each separated by 7 days. The primary efficacy endpoint was the absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) at 24 weeks.
Study results achieved a statistically significant treatment difference in favour of LAU-7b in the absolute change in the ppFEV1 through 24 weeks (p=0.0486) in people that completed at least five months of treatment (per protocol population, N=122), and a clinically meaningful reduction of 49% in the loss of lung function at 24 weeks, relative to placebo.
Proposed mode of action for LAU-7b in CF
Statistically significant clinical benefit was also observed in the relative change in ppFEV1 through 24 weeks (p=0.0351), as well as in the plasma levels of C-reactive protein (p=0.029), an important marker of systemic inflammation.
The effect appears to be maintained in the subgroup of subjects already receiving CFTR modulators, including elexacaftor-tezacaftor-ivacaftor (ETI) triple therapy. The results also passed robustness analyses, despite heterogeneous study population and pandemic interference. The study confirmed that LAU-7b has a predictable and acceptable safety profile, with no unexpected serious adverse events reported.
More details about the study can be found on www.clinicaltrials.gov (#NCT03265288).
COVID-19
A global health crisis requiring effective treatments.
COVID-19 is an acute respiratory disease borne from infection with SARS-CoV-2 coronavirus and rapidly qualified as a pandemic. While most patients are thought to have a favorable prognosis, certain patients may have worse outcomes with hyperinflammation in the lungs that may require mechanical ventilation, or chronic manifestations (long COVID).
LAU-7b: potential for dual antiviral and inflammation-controlling mechanism in COVID-19
LAU-7b
has multiple potential advantages in the treatment of COVID-19.
Once-a-day oral drug with potential for dual antiviral and inflammation-controlling effects.
Host-directed antiviral, potential to be mutation-agnostic against variants, and complementary to all virus-specific antivirals.
Pro-resolving effect on inflammation, not expected to be immunosuppressive.
Potential to be used in both the viral and inflammation phases, in the hospital or at-home, on top of standard of care.
RESOLUTION Phase 2 study with LAU-7b in hospitalized COVID-19 patients
RESOLUTION is a placebo-controlled Phase 2/3 study of oral LAU-7b, administered once-a-day for 14 days on top of standard of care, in hospitalized COVID-19 patients at risk of developing pulmonary complications.
Results from RESOLUTION Phase 2 pilot portion showed 100% reduction in the risk of progression to mechanical ventilation and death in LAU-7b-treated hospitalized moderate-to-severe COVID-19 patients, relative to placebo. Both study arms were highly comparable in terms of mean age, number of comorbidities and concomitant medications.
Patients on LAU-7b tended to recover more rapidly and leave hospital faster. LAU-7b was well-tolerated, with safety comparable to placebo.
More details about the study can be found on www.clinicaltrials.gov (#NCT04417257).
ESSOR Phase 2 study with LAU-7b in patients with Long COVID
ESSOR is a randomized, placebo-controlled, Phase 2/3 clinical trial evaluating the efficacy and safety of LAU-7b as a potential treatment for patients with Long COVID, aiming to reduce the overall disease burden on performance of daily activities. The trial builds on the known efficacy and safety profile of LAU-7b in hospitalized adults with COVID-19, as well as on the preclinical evidence of LAU-7b as a host-directed antiviral with inflammation-controlling effects in several preclinical models of respiratory and neurological inflammation.
The ESSOR Phase 2 portion will enroll 270 adults with moderate to severe Long COVID, randomized in three (3) study arms, each receiving the study medication for three (3) treatment cycles for a total duration of 12 weeks, on top of standard of care. Each treatment cycle will consist of 14 consecutive days of once-a-day oral study medication self-administered at home, followed by a 14-day drug-free period. The primary endpoint will measure the overall functional health status evaluated with the physical component score (PCS) of the SF-36 questionnaire at Week 12 compared to baseline. Secondary endpoints include evaluation of symptoms and their impact on daily activities using various tests such as the Patient Global Impression of Change (PGI-C), FACIT-Fatigue scale, the DePaul Post-Exertional Malaise Questionnaire, the EQ-5D-5L quality of life questionnaire, and Likert score.
More details about the ESSOR clinical trial can be found on www.clinicaltrials.gov, using Identifier NCT05999435.