Niclosamide

AzurRx BioPharma Announces Acquisition of First Wave Bio and its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease Indications

Retrieved on: 
Monday, September 13, 2021

BOCA RATON, Fla., Sept. 13, 2021 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has entered a definitive agreement to acquire First Wave Bio, Inc. (“First Wave Bio”) in a stock and cash transaction valued at $229 million, including certain development, regulatory and sales milestones. First Wave Bio is a clinical-stage biotechnology company specializing in the development of novel, gut-targeted, small molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious conditions.

Key Points: 
  • First Wave Bio is a clinical-stage biotechnology company specializing in the development of novel, gut-targeted, small molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious conditions.
  • Our portfolio now includes new indications for several IBDs that represent multi-billion dollar commercial market opportunities.
  • We believe the acquisition of First Wave Bio by AzurRx will unlock the value of our proprietary niclosamide formulations targeting IBD.
  • ET, to discuss the acquisition of First Wave Bio and provide a strategic outlook for the new company, First Wave BioPharma, Inc.

AzurRx BioPharma Announces Reverse Stock Split

Retrieved on: 
Friday, September 10, 2021

Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-10 reverse stock split.

Key Points: 
  • Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-10 reverse stock split.
  • It is not necessary for stockholders holding shares of the Companys common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish.
  • The reverse stock split will affect all stockholders uniformly and will not alter any stockholders percentage interest in the Companys equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share.
  • The reverse stock split will reduce the number of shares of AzurRxs common stock outstanding from approximately 93 million shares to approximately 9.3 million shares.

AzurRx BioPharma Activates New Clinical Trial Sites in India for Phase 2 RESERVOIR Trial Evaluating Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Friday, September 10, 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.
  • The seven new clinical trial sites in India, together with the existing eleven sites in the U.S. and the five trial sites recently added in the Ukraine, brings the total number of RESERVOIR trial sites to twenty-three.
  • The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study.
  • These long-term observation data could indicate that niclosamide treatment has the potential to improve long haul COVID-19 symptoms.

AzurRx BioPharma Announces Positive Results from Independent Data Monitoring Committee Review of Safety Data from Part 1 of RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Thursday, September 9, 2021

BOCA RATON, Fla., Sept. 09, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that an independent data monitoring committee (DMC) approved initiating patient enrollment in Part 2 of the ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary, oral, tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.

Key Points: 
  • The committees recommendation followed its review of safety data collected from 9 patients enrolled in Part 1 of the RESERVOIR trial.
  • James Sapirstein, President and CEO of AzurRx BioPharma, stated, We greatly appreciate the thoughtful analysis and guidance provided by the DMC following its review of the data from Part 1 of the RESERVOIR trial.
  • Consistent with our expectations, the early safety data supports the continued exploration of FW-1022 and the committee has recommended that we continue to Part 2 of the trial without modification.
  • Patients enrolled in Part 2 of the study will be chosen randomly to receive either niclosamide or a placebo.

AzurRx BioPharma to Present at the Virtual H.C. Wainwright 23rd Annual Global Investment Conference

Retrieved on: 
Tuesday, September 7, 2021

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • The Company has a pipeline of two gut-restricted GI assets in three clinical indications.
  • The lead therapeutic candidate is MS1819, a recombinant lipase developed for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.
  • This press release may contain certain statements relating to future results which are forward-looking statements.

AzurRx BioPharma Announces Positive Topline Data For Phase 2 MS1819 Combination Therapy Trial in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency (EPI)

Retrieved on: 
Wednesday, August 18, 2021
Company, Hand, CF, Standard of care, AES, Quality of life, Steatorrhea, Body mass index, U.S. Securities and Exchange Commission, Yarrowia, Incidence, GLOBE, CFA, Survival, Șaeș, Human, Cystic fibrosis, Absorption, Defecation, Malnutrition, Exocrine pancreatic insufficiency, Weight gain, Nutrient, Clinical trial, Niclosamide, NASDAQ, Safety, Cystic Fibrosis Foundation, CP, Patient, PERT, Coefficient, Diarrhea, CEO, EPI, Biopharma LLC, BOCA, Weight loss, COVID-19, Security (finance), Pharmaceutical industry, Medical imaging, Fertilizer

Topline data clearly show that combining MS1819 to the daily dose of PERT had clinical benefits for all patients and improved quality of life.

Key Points: 
  • Topline data clearly show that combining MS1819 to the daily dose of PERT had clinical benefits for all patients and improved quality of life.
  • Roughly 25% to 30% of refractory cystic fibrosis patients with severe EPI are unable to achieve adequate nutrition using PERT alone.
  • MS1819 is a recombinant lipase enzyme that is being developed for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.
  • The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.

AzurRx BioPharma Announces WHO Publication of “Adrulipase Alfa” as International Nonproprietary Name for MS1819

Retrieved on: 
Tuesday, August 17, 2021
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The assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology, said James Sapirstein, President and CEO of AzurRx.

Key Points: 
  • The assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology, said James Sapirstein, President and CEO of AzurRx.
  • AzurRx is pursuing parallel monotherapy and combination therapy clinical pathways with MS1819.
  • The WHO is expected to render a final decision on the use of adrulipase alfa for MS1819 by November 2021.
  • 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 Announces Appointment of Terry Coelho to its Board of Directors

Retrieved on: 
Monday, August 16, 2021
NASDAQ, MBA, Graduate School of Economics and International Relations, U.S. Securities and Exchange Commission, Arbutus Biopharma, Novartis, Committee, Niclosamide, DC, Mars, Clinical trial, CEO, Achievement, IBMEC, Company, American University School of International Service, Bachelor, COVID-19, International Service for the Acquisition of Agri-biotech Applications, GLOBE, EPI, Exocrine pancreatic insufficiency, Nature, Security (finance), Patient, Board, Growth, Sealed Air, Executive, Board of directors, BCPC, Knowledge, Diarrhea, Cystic fibrosis, BOCA, International relations, Management, Pharmaceutical industry

BOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (AzurRx or the Company) ( NASDAQ: AZRX ), a company specializing in the development of targeted non-systemic, therapies forgastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately.

Key Points: 
  • BOCA RATON, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (AzurRx or the Company) ( NASDAQ: AZRX ), a company specializing in the development of targeted non-systemic, therapies forgastrointestinal (GI) diseases, today announced the appointment of Terry Coelho to its Board of Directors effective immediately.
  • Terry brings to AzurRx unrivaled financial and operational experience, which will be critical to our growth and long-term success.
  • On behalf of the Board, I am pleased to welcome Terry to AzurRx and look forward to benefitting from her knowledge and expertise.
  • I am honored to be joining the Board of AzurRx BioPharma, said Ms. Coelho.

AzurRx BioPharma Completes Initial Cohort Enrollment into Part 1 of its RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Thursday, August 12, 2021
EPI, SARS2, Niclosamide, Gastrointestinal disease, Institut Pasteur Korea, Infection, World, Recurrence, GLOBE, Security (finance), COVID, FDA, Safety, DMC, PCR, Vaccine, BOCA, Patient, NASDAQ, CEO, Cystic fibrosis, Gastrointestinal tract, Diarrhea, Food, Viral load, Clinical trial, Abdominal pain, U.S. Securities and Exchange Commission, Severe acute respiratory syndrome coronavirus 2, Part Two, Tablet, Company, Vomiting, Observation, Research, Part, Biopharma LLC, GI, World Health Organization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, WHO, Review, COVID-19, Disease, Exocrine pancreatic insufficiency, Data monitoring committee, Pharmaceutical industry

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

Key Points: 
  • FW-1022 is a proprietary oral tablet formulation of micronized niclosamide for the treatment of COVID-19-related GI infections.
  • Successful DMC review will then trigger enrollment into Part 2 of the trial, focused on demonstrating efficacy and extending safety observations.
  • The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study.
  • The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of niclosamide in patients with COVID-19 Gastrointestinal Infection.

AzurRx BioPharma Adds New Clinical Trial Sites in Ukraine for Phase 2 RESERVOIR Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Retrieved on: 
Tuesday, August 10, 2021
NASDAQ, CEO, Infection, World, PPD, Inc., FDA, Patient, Population, Food, COVID-19, Viral load, GI, Clinical trial, U.S. Securities and Exchange Commission, Severe acute respiratory syndrome coronavirus 2, Institut Pasteur Korea, WHO, Cystic fibrosis, Biopharma LLC, Vomiting, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Niclosamide, Coronavirus, Recurrence, Observation, PPD, Gastrointestinal disease, GLOBE, CRO, EPI, Vaccination, Company, Exocrine pancreatic insufficiency, World Health Organization, COVID, BOCA, Diarrhea, Nature, Security (finance), Vaccine, RT-PCR, Abdominal pain, Pharmaceutical industry

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.
  • The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study.
  • These long-term observation data could indicate that niclosamide treatment has the potential to improve long haul COVID-19 symptoms.
  • AzurRx is also developing a proprietary formulation of micronized niclosamide ( FW-420 ) as a treatment for immune checkpoint inhibitor-associated colitis.