GI Medication Begins COVID-19 Phase 2 Study

A Massachusetts based biotechnology company announced plans to initiate a Phase 2a/2b study with FW-1022, a formulation of Niclosamide, in patients with COVID-19 disease.

With insights emerging into the crucial role of the gastrointestinal (GI) tract in COVID-19 severity and transmission, FirstWave Bio, Inc., said on April 9, 2020, ‘it is accelerating the clinical development of FW-1022 to meet the urgent need for new strategies to combat the virus.’

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A recent epidemiological study showed that COVID-19 patients admitted to the hospital with related GI symptoms progressed to severe/critical disease at a much higher rate than patients without these symptoms (22.97% vs 8.14%) and nearly 30 percent of patients only presented GI symptoms.

FW-1022 is a proprietary oral formulation of Niclosamide, an FDA-approved anthelminthic drug with broad-spectrum antiviral properties that are currently listed on the World Health Organization’s list of essential medicines.

FW-1022 is a gut-targeted small molecule that could have a meaningful impact on disease severity and duration, and we look forward to advancing this established antiviral strategy into clinical trials as rapidly as possible.

“FirstWave has been moving with great urgency since the emergence of COVID-19 to explore the potential of our MetaWave™ platform of oral gut-targeted medicines to address the underlying pathophysiology of this disease,” said Gary Glick, Ph.D, chief executive officer of FirstWave, in a press release.

“Studies have shown that COVID-19 invades human cells via the angiotensin-converting enzyme II receptor (ACE2), which is highly expressed on cells in lungs, GI tract, heart, kidneys, and other vulnerable organs.” 

“While lung cells that express ACE2 may be the main target for COVID-19 infection, the GI tract is believed to serve as a viral reservoir and be responsible for prolonged infection and transmission.”

FirstWave is currently scaling drug manufacturing and engaging with regulatory agencies to initiate a clinical trial of oral MetaWave, FW-1022, in patients with COVID-19. 

The company expects to initiate the clinical trial in the EU in mid-2020 and to initiate a U.S. clinical trial shortly thereafter.

Since 2015, the FirstWave team has invested in translational biology along with process development and manufacturing to develop proprietary forms of Niclosamide to maximize its therapeutic potential – producing a suite of novel therapies under the name MetaWave.

FirstWave Bio was founded to improve the lives of people living with IBD.

COVID-19 clinical trial news published by Precision Vaccinations.