Nitrobenzenes

AzurRx BioPharma Doses First Patient In Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Monday, June 7, 2021

FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections.

Key Points: 
  • FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections.
  • Dosing the first patient in the RESERVOIR clinical trial marks a significant milestone for AzurRx and the development of niclosamide as a potential treatment for COVID-19-related GI infections, said James Sapirstein, Chief Executive Officer of AzurRx BioPharma.
  • The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study.
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Hyundai Bioscience leads in the repurposing of Niclosamide

Retrieved on: 
Thursday, April 8, 2021

CNPharm also filed international patent applications on this DDS technology for repurposing Niclosamide as COVID-19 treatment.

Key Points: 
  • CNPharm also filed international patent applications on this DDS technology for repurposing Niclosamide as COVID-19 treatment.
  • This means that the international pharmaceutical community has recognized that CNPharm, the parent company of Hyundai Bioscience, is leading the way to repurpose the anthelmintic drug.
  • An official at Hyundai Bioscience stated that this is the first time that Niclosamide's bioavailability improvement for drug repurposing has been published in an international journal.
  • Based on CNPharm's original technology, Hyundai Bioscience has dramatically improved the absorption rate and half-life of Niclosamide last year, developing CP-COV03, an oral treatment for COVID-19.

AzurRx BioPharma Initiates Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Tuesday, April 6, 2021

These long term observation data could indicate that niclosamide treatment has the potential to improve long haul COVID-19 symptoms.

Key Points: 
  • These long term observation data could indicate that niclosamide treatment has the potential to improve long haul COVID-19 symptoms.
  • We look forward to testing this hypothesis in the RESERVOIR Phase 2 trial and reporting topline data from the trial in early 2022.
  • FW-1022 is a niclosamide based small molecule which the Companys clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections.
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections

Retrieved on: 
Tuesday, February 9, 2021

Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022.

Key Points: 
  • Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022.
  • Licensed by AzurRx in January from FirstWave Bio, Inc., the goal of AzurRxs FW-1022 clinical program is to develop a safe, effective, non-systemic treatment for GI infections related to COVID-19.
  • FW-1022 is a niclosamide based small molecule which the Companys clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections.
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical companyspecializingin the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases.

AzurRx BioPharma and First Wave Bio Announce Allowance of U.S. Patent Application for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections

Retrieved on: 
Tuesday, January 12, 2021

AzurRx anticipates initiating a Phase 2 trial of oral niclosamide, also called FW-1022, in patients with COVID-19, in the first half of 2021.

Key Points: 
  • AzurRx anticipates initiating a Phase 2 trial of oral niclosamide, also called FW-1022, in patients with COVID-19, in the first half of 2021.
  • We are greatly encouraged by the allowance of the patent application, said James Sapirstein, President and CEO of AzurRx BioPharma.
  • Mr. Sapirstein continued, We believe that there is both a significant unmet clinical need in treating COVID-19 GI infections and a substantial untapped market opportunity.
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical companyspecializingin the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases.

AzurRx BioPharma Announces Exclusive Worldwide License Agreement with First Wave Bio for Use of Proprietary Niclosamide Formulations to Treat Immune Checkpoint Inhibitor-Associated Colitis and COVID-19 Gastrointestinal Infections

Retrieved on: 
Monday, January 4, 2021

We believe these niclosamide formulations could offer significant advantages over other currently available treatments.

Key Points: 
  • We believe these niclosamide formulations could offer significant advantages over other currently available treatments.
  • They are not systemically absorbed, potentially allowing for higher local GI concentrations of drug delivery and avoiding steroid-related immunosuppressant complications.
  • Mr. Sapirstein continued, With these new assets, combined with our current pipeline, we believe 2021 will be a very exciting and transformational year for AzurRx.
  • Under the terms of the agreement, AzurRx is granted a worldwide, exclusive right to develop, manufacture, and commercialize First Waves proprietary immediate release oral and enema formulations of niclosamide for the treatment of ICI-AC and COVID-19 GI infections.

Hyundai Bioscience announced that its COVID-19 oral drug solved Niclosamide's inhibitory concentration problem

Retrieved on: 
Tuesday, December 8, 2020

CP-COV03 is a Niclosamide-based modified oral drug developed by CNPharm, a bio tech company holding major shares of Hyundai Bioscience.

Key Points: 
  • CP-COV03 is a Niclosamide-based modified oral drug developed by CNPharm, a bio tech company holding major shares of Hyundai Bioscience.
  • After the efficacy testing, Hyundai Bioscience plans to go for phase 2 clinical trials and then apply for emergency use approval.
  • However, Niclosamide's low bioavailability and poor inhibitory concentration level against viral activity kept it from being repositioned as a treatment for COVID-19.
  • In October, Hyundai Bioscience already confirmed the solution to the problem of low bioavailability by revealing CP-COV03's Cmax level, which was 12.5 times higher than that of existing Niclosamide.

Hyundai Bioscience: A Korean bio-tech solves the bioavailability issue of Niclosamide

Retrieved on: 
Thursday, October 29, 2020

Hyundai Bioscience's parent company, CNPharm, has succeeded in dramatically increasing the bioavailability, or absorption rate, of Niclosamide into the blood system.

Key Points: 
  • Hyundai Bioscience's parent company, CNPharm, has succeeded in dramatically increasing the bioavailability, or absorption rate, of Niclosamide into the blood system.
  • As CNPharm has solved the low bioavailability issue of Niclosamide, the possibility of an early emergence of an oral COVID-19 treatment through drug repositioning has increased.
  • In April, Niclosamide, currently an anthelmintic, was selected by the Institute Pasteur Korea as the No.
  • Since the outbreak of the COVID-19 crisis, Niclosamide has been attracting much attention as a candidate drug due to its high effectiveness in treating COVID-19.

ANA Therapeutics Begins Phase 2/3 Clinical Trial of Proprietary Oral Niclosamide Formulation to Treat COVID-19

Retrieved on: 
Monday, October 26, 2020

ANA Therapeutics announced today that it has begun a multicenter, Phase 2/3 clinical trial to evaluate the safety and efficacy of its proprietary, oral niclosamide (ANA001) formulation for the treatment of patients with moderate COVID-19 disease.

Key Points: 
  • ANA Therapeutics announced today that it has begun a multicenter, Phase 2/3 clinical trial to evaluate the safety and efficacy of its proprietary, oral niclosamide (ANA001) formulation for the treatment of patients with moderate COVID-19 disease.
  • ANA Therapeutics refocused its business with the emergence of COVID-19 to utilize our expertise in niclosamide and drug formulation, said Akash Bakshi, Co-Founder and CEO of ANA Therapeutics.
  • ANA Therapeutics is a Silicon Valley-based biotech start-up developing a proprietary niclosamide formulation as a widely accessible antiviral treatment for patients with COVID-19.
  • ANA Therapeutics is the first Y Combinator portfolio company to initiate a Phase 2 clinical trial.

Danish biotech UNION adds program to prevent COVID-19 with intranasal delivery of niclosamide

Retrieved on: 
Wednesday, October 21, 2020

HELLERUP, Denmark, Oct. 21, 2020 /PRNewswire/ -- UNION therapeutics A/S (UNION) announces expansion of the clinical pipeline with the addition of UNI91103 (intranasal niclosamide) to prevent COVID-19 and reduce the severity of the diseases among those already infected.

Key Points: 
  • HELLERUP, Denmark, Oct. 21, 2020 /PRNewswire/ -- UNION therapeutics A/S (UNION) announces expansion of the clinical pipeline with the addition of UNI91103 (intranasal niclosamide) to prevent COVID-19 and reduce the severity of the diseases among those already infected.
  • Several high-risk patient groups do not respond well to vaccination suggesting a persistent need for alternative prophylactic measures.
  • In response, UNION has expanded its clinical program for COVID-19 with a niclosamide based nasal spray (UNI91103) to prevent and alleviate infection among people at risk.
  • Furthermore, niclosamide has been demonstrated to prevent fatal outcomes in a murine model of COVID-19 when administered intranasally2.