Niclosamide

First Wave BioPharma to Participate in “Fireside Chat” at the H.C. Wainwright Global Investment Conference

Retrieved on: 
Tuesday, May 17, 2022
Company, U.S. Securities and Exchange Commission, Niclosamide, Ulcerative colitis, Patient, Cystic fibrosis, EPI, Digestion, FW, Clinical trial, COVID-19, Nutrient, Acquisition, Fats, Exocrine pancreatic insufficiency, Diarrhea, Security (finance), Pharmaceutical industry

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave BioPharmas niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV for COVID-19 gastrointestinal infections and FW-UP for ulcerative proctitis (UP) and ulcerative proctosigmoiditis.
  • The Company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.
  • First Wave BioPharma is headquartered in Boca Raton, Florida.

First Wave BioPharma Chairman and CEO Issues Letter to Shareholders

Retrieved on: 
Friday, April 29, 2022
CD, SARS2, CEO, Exocrine pancreatic insufficiency, Gastrointestinal disease, Patient, Letter, Cell death, GLOBE, UPS, Tissue, DDW, Oxidative phosphorylation, UC, Conference, Quality of life, EPI, Inflammatory bowel disease, IBD, Pancolitis, Acquisition, BOCA, First wave, Niclosamide, Research, Ulcerative colitis, UP, NASDAQ, Apoptosis, T helper 17 cell, FW, Mitochondrion, Inflammation, Severe acute respiratory syndrome coronavirus 2, Health, Cystic fibrosis, Safety, CP, Pharmaceutical industry

BOCA RATON, Fla., April 29, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (First Wave BioPharma or the Company), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases, today announced thatJames Sapirstein, Chairman, President and CEO First Wave BioPharma, has issued a Letter to Shareholders to provide an update on recent events and an outlook for the Companys clinical programs in 2022.

Key Points: 
  • BOCA RATON, Fla., April 29, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (First Wave BioPharma or the Company), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases, today announced thatJames Sapirstein, Chairman, President and CEO First Wave BioPharma, has issued a Letter to Shareholders to provide an update on recent events and an outlook for the Companys clinical programs in 2022.
  • FW-COV was demonstrated to be very safe with no serious adverse events reported by the more than 150 patients who participated in the trial.
  • We are still awaiting the complete set of data for analysis, including anti-inflammatory biomarkers, abdominal discomfort changes, and medium-term safety follow-up.
  • As a result of this development and the ongoing volatility in the biotechnology sector, effective immediately, First Wave BioPharma will be initiating austerity measures to conserve capital.

TFF Pharmaceuticals Announces Safety and Pharmacokinetic Data from Phase 1 Study of Niclosamide Inhalation Powder

Retrieved on: 
Tuesday, April 19, 2022
Irritation, Inhalation, Government, COVID-19, NASDAQ, Cmax, GLOBE, Patient, Blood, TFF, Tmax, Technology, Nasal cavity, Absorption, FDA, Therapy, Freezing, PK, MAD, Annual report, Food, Single, Powder, Șaeș, Company, Disease, FEV1, CEO, BID, Nose, Half-life, Entrepreneurship, Solubility, Skin, Principal, Safety, Niclosamide, SAD, Infection, Toxicity, Lung, Vaccine, Volunteering, Risk, Severe acute respiratory syndrome coronavirus 2, Voriconazole, Pharmaceutical industry, Generic drug, Delta, Omicron

FORT WORTH, Texas, April 19, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced safety and pharmacokinetic (PK) data from its Phase 1 study of Niclosamide Inhalation Powder, which is being developed for the treatment of COVID-19.

Key Points: 
  • We are very pleased to announce these positive safety and PK data for our Niclosamide Inhalation Powder, said Glenn Mattes, CEO of TFF Pharmaceuticals.
  • It is great to follow theprogress and success of the TFFNiclosamide Inhalation Powder program, stated Rasmus Toft-Kehler, Ph.D., Chief OperatingOfficerand Co-Founder of UNION Therapeutics.
  • The Phase 1 trial of Niclosamide Inhalation Powder consisted of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) phase.
  • Phase 1 study results show that Niclosamide Inhalation Powder was well tolerated with no dose limiting cough or irritation.

First Wave BioPharma Files U.S. and PCT Patent Applications for Niclosamide in Long-Haul COVID-19

Retrieved on: 
Monday, March 28, 2022
Diarrhea, Niclosamide, Ulcerative colitis, World Health Organization, CEO, Fats, Intellectual property, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gastrointestinal disease, GLOBE, Security (finance), Vaccination, FW, Biopharma LLC, Cystic fibrosis, GI, U.S. Securities and Exchange Commission, Vomiting, Exocrine pancreatic insufficiency, Nutrient, NASDAQ, WHO, Clinical trial, Digestion, World, Severe acute respiratory syndrome coronavirus 2, SARS2, Infection, BOCA, COVID, FDA, Patient, IP, Company, First wave, PCT, Viral load, Food, USPTO, Safety, Patent, COVID-19, EPI, Acquisition, Abdominal pain, Pharmaceutical industry

The Company has filed U.S. Patent and Patent Cooperation Treaty (PCT) applications entitled Treatment of Long Haulers Syndrome with Niclosamide (U.S.

Key Points: 
  • The Company has filed U.S. Patent and Patent Cooperation Treaty (PCT) applications entitled Treatment of Long Haulers Syndrome with Niclosamide (U.S.
  • Niclosamide is a widely prescribed small molecule with anti-inflammatory and antiviral properties that has been safely used on millions of people worldwide.
  • First Wave BioPharma is developing a proprietary oral formulation of niclosamide, FW-COV, as a treatment for COVID-19-related GI infections.
  • First Wave BioPharma expects to report top-line data in the first half of 2022.

First Wave BioPharma to Participate in Maxim’s 2022 Virtual Growth Conference

Retrieved on: 
Tuesday, March 22, 2022
Exocrine pancreatic insufficiency, Company, Nutrient, FW, Diarrhea, Clinical trial, Digestion, Niclosamide, Ulcerative colitis, Cystic fibrosis, U.S. Securities and Exchange Commission, Fats, COVID-19, EPI, Acquisition, Patient, Security (finance), Pharmaceutical industry

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave BioPharmas niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV for COVID-19 gastrointestinal infections and FW-UP for ulcerative proctitis (UP) and ulcerative proctosigmoiditis.
  • The Company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.
  • First Wave BioPharma is headquartered in Boca Raton, Florida.

First Wave BioPharma to Participate in ”Fireside Chat” at the 34th Annual Roth Conference

Retrieved on: 
Tuesday, March 8, 2022
EPI, Patient, Ulcerative colitis, Security (finance), U.S. Securities and Exchange Commission, Digestion, Nutrient, Company, COVID-19, Acquisition, FW, Fats, Niclosamide, Clinical trial, Diarrhea, Cystic fibrosis, Exocrine pancreatic insufficiency, Pharmaceutical industry

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave BioPharmas niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV for COVID-19 gastrointestinal infections and FW-UP for ulcerative proctitis (UP) and ulcerative proctosigmoiditis.
  • The Company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.
  • First Wave BioPharma is headquartered in Boca Raton, Florida.

First Wave BioPharma, Inc. Announces Closing of $9 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Retrieved on: 
Wednesday, March 2, 2022
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The gross proceeds from the offering were approximately $9 million.

Key Points: 
  • The gross proceeds from the offering were approximately $9 million.
  • The offering was made by the Company pursuant to a shelf registration on Form S-3 (File No.
  • 333-256476) (including a base prospectus) with the Securities and Exchange Commission (SEC), which was declared effective on June 2, 2021.
  • These forward-looking statements are subject to risks and uncertainties including, among other things, the intended use of proceeds from the registered direct offering.

First Wave BioPharma Announces Appointment of Sarah Romano as Chief Financial Officer

Retrieved on: 
Tuesday, March 1, 2022
GLOBE, Niclosamide, BOCA, Board of directors, Ulcerative colitis, Holy Cross, First wave, Board, Nutrient, TechTarget, Interim, Security (finance), NASDAQ, Cognex Corporation, College, Diarrhea, CFO, Digestion, COVID-19, Genesys, Company, Inflammatory bowel disease, PricewaterhouseCoopers, Clinical trial, Cystic fibrosis, Comptroller, U.S. Securities and Exchange Commission, Acquisition, FW, Senior, Exocrine pancreatic insufficiency, Steatorrhea, Market for corporate control, Patient, EPI, Interim management, CEO, Fats, Software, Pharmaceutical industry, Management

BOCA RATON, Fla., March 01, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (First Wave BioPharma or the Company), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases, announced today that Sarah Romano has joined the Company as its Chief Financial Officer (CFO) effective immediately.

Key Points: 
  • BOCA RATON, Fla., March 01, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (First Wave BioPharma or the Company), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases, announced today that Sarah Romano has joined the Company as its Chief Financial Officer (CFO) effective immediately.
  • James Sapirstein, Chairman and CEO of First Wave BioPharma, stated, We are excited to add Sarah to the First Wave BioPharma team.
  • Her recent positions as Chief Financial Officer, Corporate Controller, and her other financial and accounting roles within pharmaceutical and healthcare companies, showcase her ability to support a fast-growing organization.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

First Wave BioPharma, Inc. Announces $9 Million Registered Direct Offering Priced At-The-Market Under NASDAQ Rules

Retrieved on: 
Monday, February 28, 2022
GLOBE, Niclosamide, BOCA, U.S. Securities and Exchange Commission, Ulcerative colitis, Nutrient, Security (finance), NASDAQ, SEC filing, Diarrhea, Digestion, COVID-19, Company, Clinical trial, Sale, Cystic fibrosis, LLC, Form, Acquisition, Exercise, FW, Degenerative disease, Exocrine pancreatic insufficiency, Park, Patient, EPI, Fats, Telephone, SEC, Pharmaceutical industry, Nasdaq

The closing of the offering is expected to occur on or about March 2, 2022, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering is expected to occur on or about March 2, 2022, subject to the satisfaction of customary closing conditions.
  • H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
  • The gross proceeds from the offering are expected to be approximately $9 million.
  • These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds from the registered direct offering.

TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2

Retrieved on: 
Thursday, February 24, 2022
GLOBE, Niclosamide, Lung, Risk, SAD, Mortality, COVID-19, UNION, Pharmacokinetics, NASDAQ, Single, University of Alabama at Birmingham School of Medicine, TFF, Annual report, Therapy, Company, Volunteering, UAB School of Dentistry, Safety, Disease, Temperature, Food, Severe acute respiratory syndrome coronavirus 2, News, Infection, FDA, BID, MAD, Safety management system, Solubility, Microbiology, CEO, Urinary tract infection, Absorption, Vaccine, Pharmaceutical industry, Generic drug, Omicron, Delta, Medicine

AUSTIN, Texas, Feb. 24, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the Company’s inhaled niclosamide product candidate completely inhibits viral replication of both the Delta and Omicron variants of SARS-CoV-2.

Key Points: 
  • Compared to data from previously published studies, the results demonstrate that inhaled niclosamide appears to be the most potent inhibitor of SARS-CoV-2 replication, including the Omicron variant.
  • More specifically, nirmatrelvir and molnupiravir each showed complete inhibition of the Omicron variant at 2.5M.1 In the studies announced today by TFF Pharmaceuticals, inhaled niclosamide demonstrated complete inhibition of Omicron at only 1M.
  • In a Phase 1 study, TFF Pharmaceuticals has already demonstrated that a 6 mg BID dosing of inhaled niclosamide is well tolerated.
  • The data demonstrating that niclosamide inhibits viral replication of the Omicron variant is proof of concept for the activity of the drug against SARS-CoV-2, said Dr. Michael Saag, Professor of Medicine at UAB School of Medicine and Member of the TFF Pharmaceuticals Scientific Advisory Board.Niclosamides mechanism of action, which inhibits human pathways involved in viral replication, restricts development of mutations in the viral genome.