View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
October 1, 2021updated 11 Jul 2022 2:47pm

Laurent’s LAU-7b fails to meet primary goal in Phase II Covid-19 trial

In moderate-to-severe Covid-19 patients, LAU-7b plus SOC offered a complete decline in the risk of all-cause mortality by day 60.

Laurent Pharmaceuticals has reported that its pro-resolving drug candidate, LAU-7b, failed to meet the primary goal of the Phase II RESOLUTION clinical trial in hospitalised Covid-19 patients.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

LAU-7b is a new oral form of fenretinide, an atypical retinoid that acts on certain cell membrane lipids linked to viral replication and immune-inflammatory responses.

The double-blind, placebo-controlled Phase II trial assessed the efficacy and safety of a once-daily oral dose of LAU-7b administered for 14 days, along with the standard of care (SOC).

It enrolled a total of 232 hospitalised patients with moderate, severe or critical Covid-19 disease.

Of these, 148 subjects had moderate-to-severe disease who did not need oxygen or low-flow oxygenation and 84 patients were critically ill needing high-flow oxygen but not mechanical ventilation.

According to data from the overall moderate-to-critical patient population, the trial failed to meet its primary goal of improving the proportion of subjects alive and free of respiratory failure on day 29.

A clinically meaningful efficacy signal was attained in the pre-specified subgroup of moderate-to-severe Covid-19 patients.

In addition, LAU-7b plus SOC offered a complete decline in the risk of all-cause mortality and the risk of progression to mechanical ventilation by day 60 versus placebo.

In the moderate-to-severe Covid-19 patients, the trial demonstrated a 6.9% relative rise against placebo in the proportion of patients alive and free of respiratory failure at day 29 in those receiving LAU-7b.

Furthermore, LAU-7b demonstrated to be well-tolerated, with a safety profile in line with the placebo group and consistent with the already known safety data.

The subgroup analysis of critically ill Covid-19 patients did not demonstrate an improvement in the LAU-7b group versus placebo. This indicates that these patients may be too severely affected to benefit from the LAU-7b therapy, Laurent noted.

Laurent Pharmaceuticals president and CEO Radu Pislariu said: “The results from the moderate-to-severe subgroup are very promising, suggestive of a potential clinical benefit of LAU-7b in Covid-19 patients that are not yet in respiratory failure, which also represents the patient population with the fewest treatment options.

“An oral therapeutic that prevents serious Covid-19 illness and death, also allowing patients to continue the treatment at home after discharge from hospital, would be a powerful tool in the therapeutic arsenal against Covid-19.”

Based on the topline data from the trial, Laurent intends to focus its future development on moderate-to-severe Covid-19 patients and the key goals linked to the observed clinical benefit.

The company also plans to seek guidance from various drug regulators on potential future strategies.

In April 2021, Laurent decided to continue the study of LAU-7b without modification in the Phase II RESOLUTION study in hospitalised Covid-19 patients.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena