Candidate: Niclosamide (FW-1022)

Type: Oral small molecule chlorinated salicylanilide analog with antihelminthic and potential antineoplastic activity. Niclosamide was approved by the FDA in 1982 for the treatment of intestinal tapeworm infections.

2021 Status: AzurRx said February 9 it entered into an agreement with the global contract research organization (CRO) PPD to oversee a planned Phase II clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal (GI) infections.  PPD plans to manage the Phase II clinical trial for an immediate-release capsule formulation of micronized oral niclosamide.

Licensed in January from First Wave Bio, AzurRx’s FW-1022 clinical program is designed to develop a safe, effective, non-systemic treatment for GI infections related to COVID-19. AzurRx said it anticipated starting the trial in the first half of 2021.

On January 12, AzurRx and First Wave said the U.S. Patent and Trademark Office (USPTO) provided a notice of allowance for issuance of a patent (U.S. patent application number 16/835,307) covering use of niclosamide as a treatment for COVID-19-associated GI disease.  The allowed claims related to a method for treating a digestive symptom in a subject diagnosed as having a COVID-19 viral infection comprising orally administering an effective amount of niclosamide to decrease the COVID-19 viral RNA load relative to a baseline.

AzurRx said January 4 it signed an exclusive worldwide licensing agreement with First Wave to use their patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and COVID-19 GI infections.

First Wave granted AzurRx a worldwide, exclusive right to develop, manufacture, and commercialize niclosamide. In return, AzurRx agreed to pay First Wave $10.25 million in cash upfront, payable $9 million at closing and $1.25 million by June 30, 2021, followed by $3 million of Convertible Junior Preferred Stock, to be convertible into common stock following shareholder approval, and up to $74 million in payments tied to achieving development and commercial milestones, as well as mid single-digit royalties on product sales for the ICI-AC and COVID-19 GI indications.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types: