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 September 10 that it had activated seven new clinical trial sites in India for the ongoing Phase II RESERVOIR trial (NCT04858425) evaluating FW-1022. The seven new clinical trial sites in India, together with the existing 11 sites in the U.S. and five trial sites recently added in the Ukraine, brings the total number of RESERVOIR trial sites to 23. AzurRx said it expected to report topline results during the first quarter of 2022.
On June 7, AzurRx administered the first dose of Niclosamide to a volunteer in the ongoing Phase II RESERVOIR trial. Topline results from the trial are expected in the first quarter of 2022.
RESERVOIR is a two-part, two-arm, placebo-controlled study whose primary objectives are to confirm the safety of Niclosamide in the treatment of patients with COVID-19-related GI infections and to evaluate its efficacy in clearing SARS-CoV-2 from the GI tract. The primary efficacy measure of RESERVOIR is the rate of fecal SARS-CoV-2 clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months. According to AzurRx, the long-term observation data could indicate that niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms.
On February 9, AzurRx 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: