FirstWave Bio to Initiate Phase 2a/2b Study of FW-1022, a Proprietary Form of Niclosamide, to Treat COVID-19

April 9, 2020

Proprietary formulation of approved antiviral medicine targets viral “reservoir” in the gut believed responsible for prolonged infection and transmission

Company accelerating to dose first COVID-19 patients beginning mid-2020

BOSTON, Mass. – April 09, 2020 – FirstWave Bio, Inc., a clinical-stage biotechnology company developing novel gut-targeted small molecules for inflammatory bowel disease and other serious conditions, today announced plans to initiate a Phase 2a/2b study in patients with COVID-19, beginning in mid-2020.

With insights emerging into the crucial role of the gastrointestinal (GI) tract in COVID-19 severity and transmission, the company is accelerating clinical development of FW-1022 to meet the urgent need for new strategies to combat the virus. FW-1022 is a proprietary oral formulation of Niclosamide, an FDA-approved anthelminthic drug with broad spectrum antiviral properties that is currently listed on the World Health Organization’s list of essential medicines.

“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. “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.

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% of patients only presented GI symptoms. 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 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.

Beyond COVID-19, the company is currently advancing an ongoing Phase 2a trial of MetaWave product candidate FW-424 which has generated strong efficacy and safety results in patients with mild-to-moderate ulcerative colitis (UC) who received a low dose of the therapy.

About FirstWave Bio

FirstWave Bio was founded to improve the lives of people living with IBD. Recent discoveries in immune cell metabolism have opened up the possibility of selectively targeting disease-causing immune cells to treat inflammatory diseases without unwanted side effects such as broad immunosuppression. FirstWave has developed a suite of MetaWave product candidates, gut-restricted small molecules that target the metabolism of disease-causing Th17 cells. The company’s first clinical MetaWave program, FW-424, has shown benefits for patients with mild-to-moderate ulcerative colitis in a Phase 1b/2a trial. FirstWave is advancing FW-424 through additional clinical studies in patients with mild-to-moderate IBD. Given FW-424’s novel mechanisms of action and established safety profile, FirstWave believes that it has the potential to replace current standard-of-care and improve the lives of patients at all stages of IBD. For more information, visit firstwavebio.com

Media Contact

Stefan Riley, (617) 461-2442
Ten Bridge Communications
stefan@tenbridgecommunications.com

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