In an exclusive interview with The Fly, AzurRx BioPharma (AZRX) President and CEO James Sapirstein talked about the company, ongoing clinical trials, COVID-related GI infections and much more. Here are some highlights:
COVID-ASSOCIATED GI INFECTIONS: Last month, AzurRx announced a pact with PPD (PPD) for a Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal infections.
"Niclosamide is a very old product for parasites and antiparasitic that was approved in the U.S. in 1982. When COVID broke out and people started looking at products that could be repurposed to work against COVID, niclosamide showed incredible activity against COVID. We now contracted with PPD to conduct our Phase 2 trial," AzurRx's CEO James Sapirstein explained to The Fly. "First Wave Bio had its IND approved by the FDA back in September, so they're allowing us to go right to a proof-of-concept trial with PPD, most likely by the end of this month or early next month. We should get emergency authorization use if it works."
Earlier this year, AzurRx signed an exclusive worldwide licensing agreement with First Wave Bio for the use of its patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis and COVID-19 GI infections.
MARKET OPPORTUNITY IN COVID-RELATED GI INFECTIONS: AzurRx CEO sees the market opportunity in COVID-19 GI infections as "quite large." "We believe COVID hides in certain reservoirs. That's why we have people – they are calling them the 'long haulers' – who had COVID and still have symptoms associated with it: they can't breathe very well, they get headaches, brain fog... and we have seen studies that in 48% of patients who had COVID, they still have positive RNA in their stools," the CEO explained.
"We're positive that COVID lives in the GI tract and that niclosamide will be able to take COVID out of the GI tract and hopefully also prevent it from hiding there as well. The sky is the limit in terms of market opportunity. [...] You're looking at a several billion-dollar asset."
MS1819 PHASE 2 TRIALS: The company's lead therapeutic candidate MS1819 is also currently in two Phase 2b clinical trials with data expected in the first half of 2021, namely Phase 2b OPTION 2 extension study evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis, and a Phase 2b combination therapy trial. "We're pretty close to finishing up the OPTION 2 trial right now and we will have top line data at the end of this month. The other trial [...] is also very close to closing. We will have data on that in the second quarter of this year," Sapirstein said.
FW-420 TRIALS: Discussing candidate FW-420, AzurRx's CEO said he expects to launch the trial in the first half of this year, "probably closer to June," with the study taking anywhere from 14 to 18 months. "This is niclosamide for checkpoint inhibitor colitis. Some of products used in cancer therapy right now – such Opdivo and Keytruda – have diarrhea as a side effect that leads to colitis. Our goal is having niclosamide prevent the inflammation process around colitis. We're going to look specifically at checkpoint inhibitor colitis," he explained to The Fly.
FULLY CAPITALIZED: Looking at the remainder of the year, AzurRx CEO sees things "progressing nicely" and believes "2021 will be a super year" for the company. "We're getting closer to data and we were able to do a capital raise that paid for the deal with First Wave Bio. Things are going great. We're fully capitalized, with enough money to get us through the end of MS1819 trials and launch the other two trials," Sapirstein said.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
For more on AzurRx BioPharma's Niclosamide Phase 2b trials click here.
For more on the market opportunity in COVID-related GI infections click here.
For more on AzurRx BioPharma's MS1819 trials click here.
For more on AzurRx BioPharma's FW-420 trials click here.
For more on AzurRx capital situation click here.