Foresee Pharmaceuticals begins FP-025 phase 2/3 trial in Covid-19 associated ARDS

TAGS

Foresee Pharmaceuticals has started patient dosing in a phase 2/3 trial of in adults having severe to critical Covid-19 with associated (ARDS).

According to the Taiwanese pharma company, FP-025 is an oral small molecule inhibitor of MMP-12, whose main functions are the modulation of various components such as elastin and collagen of the extracellular matrix.

– founder and Chairman of said: “We are pleased to begin this Phase 2/3 study of FP-025. FP-025 showed significant therapeutic efficacy in preclinical inflammation and fibrosis models of the lung, suggesting that FP-025 may potentially avert the lung injury and fibrosis caused by COVID–19 infections.

See also  Northway Biotechpharma to manufacture Memo’s Covid1-9 drug MTX-COVAB

“We look forward to evaluating the potential of FP-025 in the fight against the pandemic.”

Foresee Pharmaceuticals begins FP-025 phase 2/3 trial in Covid-19 associated ARDS

Foresee Pharmaceuticals begins FP-025 phase 2/3 trial in Covid-19 associated ARDS. Image courtesy of PIRO4D from Pixabay.

The phase 2/3 clinical trial of FP-025 is a double-blind, placebo-controlled study for assessing its efficacy and safety in randomly grouped patients with severe to critical Covid-19 with associated acute respiratory distress syndrome, totaling around 99.

The phase 2 part of the clinical trial will be carried out in the US.

The patients will be grouped in a 1:1:1 ratio for getting FP-025 100mg, FP-025 300mg, or placebo daily two times for 28 days. The primary outcome measures of the mid-stage trial include the proportion of patients who have survived and do not need non-invasive or invasive ventilation at Day 28.

See also  CVC Capital Partners leads consortium in €3.03bn acquisition of Recordati

Foresee Pharmaceuticals plans to have an interim analysis at the end of the phase 2 trial, of which the efficacy results are anticipated to be out in Q4 2021.

Depending on the primary analysis results from the phase 2 study, an optimal dose will be picked to carry into phase 3 of the trial, where nearly 300 patients will be randomized in a 1:1 ratio to get either FP–025 or placebo for a period of 28 days.


Discover more from Business-News-Today.com

Subscribe to get the latest posts sent to your email.

CATEGORIES
TAGS
Share This