LOS ANGELES, Nov. 24, 2020 (GLOBE NEWSWIRE) -- via InvestorWire – InvestorBrandNetwork (“IBN”), a multifaceted communications organization engaged in connecting public companies to the investment community, is pleased to announce the release of the latest episode of the Stock2Me Podcast as part of its sustained effort to provide specialized content distribution via widespread syndication channels.
Stock2Me Podcasts feature a fascinating array of companies and individuals, many of whom are actively revolutionizing age-old business practices within their respective markets.
“AzurRx Bio has been around for five years. … Our main product, MS1819, is being studied in chronic pancreatitis and in the GI effects of cystic fibrosis,” Sapirstein stated in the interview. “The market for this particular product (in chronic pancreatitis, competing against pancreatic enzyme replacement therapy (PERT) is about $1 billion outside of the United States and several hundred million dollars inside the United States. The other market is cystic fibrosis. It’s over a $2 billion market worldwide for PERT.”
AzurRx currently has two ongoing clinical trials for MS1819. The first is a Phase 2 Cystic Fibrosis Combination Trial examining MS1819 in combination with PERT, which is expected to produce topline data in Q2 2021.
The company’s second ongoing trial is a Phase 2b Cystic Fibrosis Option 2 monotherapy trial that is expected to produce topline data in Q1 2021. Describing this study, Sapirstein noted, “This is a crossover design study. We place patients on PERT, the existing standard of care therapy, and we also put another line of patients on our drug. These patients take the drugs for three weeks, then we crossover. These patients are not being studied versus placebo. … We’re actually adding another arm where we can dose escalate, because we enrolled the trial very quickly despite COVID. … Because of that, we decided to get some more data out of this trial with another arm.”
Sapirstein went on to discuss the impacts of COVID-19 on AzurRx. The company made a number of adjustments to its clinical development strategy in an effort to better navigate the pandemic. “I immediately, back in February, told my clinical group that this virus is going to be pretty bad and a lot of countries are going to start shutting down. For our combination trial, we decided to start getting some backups. We called the folks in Europe that were working on our trial and told them to get as many patients as possible,” he said. “We also opened up Poland and Turkey. … It takes several months to get these sites up and running and calibrated, so, on the combination trial, we lost about a month on COVID, but not a significant amount of time.”
“In the United States, we took a very different approach with our Option 2 trial,” Sapirstein continued. “Because these patients don’t need a lot of bloodwork, we decided to sequester these folks in hotels. Obviously, there was a lot of hotel space available. We put that into our protocol; we got it approved by the FDA. … That’s how we were able to do it this quickly.”
Join InvestorBrandNetwork’s Stuart Smith and AzurRx’s James Sapirstein in exploring how AzurRx is working to redefine the standard of care for patients living with cystic fibrosis and chronic pancreatitis.
To catch the entire episode and subscribe for future episodes please visit: https://podcast.stock2me.com
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