First wave

First Wave BioPharma Announces Initiation of Phase 2 Trial Investigating Enhanced Adrulipase Formulation in Exocrine Pancreatic Insufficiency in Patients with Cystic Fibrosis

Retrieved on: 
Tuesday, January 31, 2023
Food, PERT, Safety, EPI, Patient, First wave, Stomach, IND, Cystic fibrosis, Exocrine pancreatic insufficiency, SPAN, CFA, Capsule, Malabsorption, Clinical trial, FDA, Gastrointestinal tract, CNA, Investigational New Drug, BOCA, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Enzyme replacement therapy, Pharmaceutical industry

The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients.

Key Points: 
  • The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients.
  • First Wave BioPharma expects to initiate patient screening in early February 2023, with topline data anticipated by mid-2023.
  • “We are very pleased to announce the initiation of the Phase 2 clinical trial investigating our new formulation of adrulipase as a potential treatment for EPI associated with cystic fibrosis and chronic pancreatitis,” said James Sapirstein, President and CEO of First Wave BioPharma.
  • The Phase 2 SPAN trial is designed to investigate the safety, tolerability and efficacy of a new enteric microgranule formulation of adrulipase.

First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio

Retrieved on: 
Wednesday, January 25, 2023
Food, PERT, EPI, IND, First wave, Stomach, Steatorrhea, Cystic fibrosis, Exocrine pancreatic insufficiency, Intellectual property, Therapy, CP, Capsule, IP, Patient, Patent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Investigational New Drug, BOCA, Research, Pharmaceutical industry

Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile.

Key Points: 
  • Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile.
  • This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase.
  • Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.
  • “Enhancing the IP portfolio protecting adrulipase and the microgranule drug delivery formulation is an important value-building opportunity for First Wave as we prepare to soon initiate the Phase 2 clinical trial of adrulipase in exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis,” said James Sapirstein, President and CEO of First Wave BioPharma.

First Wave BioPharma Provides Update on IND Filing For Phase 2 Trial of Enhanced Microgranule Formulation of Adrulipase for Exocrine Pancreatic Insufficiency

Retrieved on: 
Friday, January 13, 2023
IND, CP, Cystic fibrosis, EPI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, First wave, Policy, Food, Patient, Investigational New Drug, Exocrine pancreatic insufficiency, BOCA, Clinical trial, Pharmaceutical industry

Under FDA’s policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources.

Key Points: 
  • Under FDA’s policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources.
  • The Company previously announced that it submitted the IND amendment to the FDA on November 30, 2022.
  • First Wave BioPharma has been in conversations with FDA and expects a forthcoming response around the end of January.
  • “We are eager to evaluate the potential of our enhanced microgranule delivery formulation of adrulipase in the proof-of-concept Phase 2 clinical trial, which we are prepared to initiate immediately after the IND protocol amendment is cleared,” said James Sapirstein, President and CEO of First Wave BioPharma.

First Wave BioPharma Announces Adjournment of Special Meeting

Retrieved on: 
Monday, January 9, 2023
EST, Communication, Special, First wave, BOCA, Proxy, Holding company, Shareholder

BOCA RATON, Fla., Jan. 09, 2023 (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 for gastrointestinal (GI) diseases, today announced that it has adjourned its Special Meeting of Stockholders (the “Special Meeting”) in order to provide stockholders additional time within which to vote on all proposals.

Key Points: 
  • BOCA RATON, Fla., Jan. 09, 2023 (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 for gastrointestinal (GI) diseases, today announced that it has adjourned its Special Meeting of Stockholders (the “Special Meeting”) in order to provide stockholders additional time within which to vote on all proposals.
  • Therefore, the Company adjourned the Special Meeting.
  • The adjourned meeting will be held at 9:00 a.m. EST on January 13, 2023 at the following url: www.virtualshareholdermeeting.com/FWBI2023SM.
  • Special Meeting of Stockholders of First Wave BioPharma, Inc.

ZyVersa Therapeutics Appoints Three New Board Members

Retrieved on: 
Thursday, January 5, 2023
Medical device, General counsel, Kidney, Cancer, Therapy, Drug development, Knowledge, Pfizer, Infection, VAR, Inflammation, PDS, Regenerative medicine, Gilead Sciences, Biotechnology, CPA, Retirement, BIO, Business development, Public policy, Degenerative disease, Guidant, Lundbeck, BMS, AxoGen, Neurology, First wave, Health care, Laboratory, Immunology, Richard Barker (life sciences and healthcare leader), Senior, Roche, Doctor of Philosophy, Pharmaceutical industry, Management, Allergan

ZyVersa appoints three new independent board members, bringing the total board membership to seven.

Key Points: 
  • ZyVersa appoints three new independent board members, bringing the total board membership to seven.
  • The existing board of ZyVersa appointed the following new board members: Gregory G. Freitag, J.D., CPA; Katrin Rupalla, PhD; and James Sapirstein.
  • "We are delighted to welcome our three new board members at this important time in ZyVersa's evolution," stated Stephen C. Glover.
  • Dr. Rupalla is also the Chair of the board of AMBRX, and a board member of the non-profit Cancer Drug Development Forum.

First Wave BioPharma to Participate in BIO Partnering @ JPM During “J.P. Morgan Week 2023”

Retrieved on: 
Monday, December 12, 2022
Nutrient, Acquisition, Ulcerative colitis, CP, Digestion, Clinical trial, Security (finance), EPI, CF, Cystic fibrosis, Exocrine pancreatic insufficiency, First wave, Niclosamide, FW, Patient, Fats, 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 is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).
  • First Wave BioPharma is headquartered in Boca Raton, Florida.
  • This press release may contain certain statements relating to future results which are forward-looking statements.

First Wave BioPharma Announces Initial Clinical Sites for its Phase 2 Trial of Enhanced Microgranule Delivery Formulation of Adrulipase

Retrieved on: 
Monday, December 5, 2022
Nutrient, Conference, Ulcerative colitis, Capsule, Weight loss, Acquisition, CP, Digestion, Clinical trial, Cystic fibrosis, Diarrhea, Security (finance), EPI, CF, M.D, Cystic Fibrosis Foundation, Yarrowia, Exocrine pancreatic insufficiency, PERT, First wave, Disease, Niclosamide, FW, Steatorrhea, Patient, Fats, Pharmaceutical industry

First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.

Key Points: 
  • First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.
  • This ‘pill burden’ presents a substantial challenge for EPI patients,” said Dr. Steven Boas, M.D, founder of the Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).

One Solution / One X Studios Takes Home a "Model D" Award for Best Documentary, Single or Series for One Yard "The Show" During the 2022 Cynopsis Model D & It List Awards

Retrieved on: 
Thursday, December 15, 2022
One Solution, Jackson State Tigers football, Show, CLEO, Culture, Russ Parr, Television, HBCU, Sonic boom, Urban One, Jackson State University, Life, School, Partnership, African Americans, Rickey Smiley, Sonic Boom of the South, First wave, Radio, Student, MadameNoire, Jackson, AM, TV1, Interview, Tiger, CLEO TV, Historically black colleges and universities, News, Multimedia, Yard, Players, MGM National Harbor, Video game

Urban One Inc. applauds the One Solution / One X Studios teams for winning a "Model D Award" for Best Documentary, Single or Series - One Yard "The Show."

Key Points: 
  • Urban One Inc. applauds the One Solution / One X Studios teams for winning a "Model D Award" for Best Documentary, Single or Series - One Yard "The Show."
  • The range of contenders was dynamic, including Black Planet Documentary, Rise of the Players, The First Wave and Jacinta.
  • This recognition takes the One Solution / One X Studios team's growing total to an impressive thirty-nine accolades.
  • Produced series to provide viewers with the opportunity to engage in a homecoming experience they know andlove.

Michael Dowling Named America’s Most Influential Health Care Leader

Retrieved on: 
Monday, December 5, 2022
General Health, Health, Health Insurance, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Physician, UnitedHealth Group, Feinstein Institute for Medical Research, Heel, Gun, Patient, First wave, Darkness, Hospital, Death, Nursing, Credit, Office of Inspector General, U.S. Department of Health and Human Services, Maternal health, Medicine, Health care, Health equity, Border, COVID-19, Multimedia, CVS Health, Mortality, Mother, Violence, Medical research, Médecins Sans Frontières, Organization, Pharmaceutical industry, Health, Modern Healthcare, Northwell Health

Northwell Health President and CEO Michael Dowling , who championed innovation to combat the COVID-19 pandemic and was just as aggressive toward health equity and gun violence as a public health crisis, has been selected as Americas most influential leader in health care by Modern Healthcare.

Key Points: 
  • Northwell Health President and CEO Michael Dowling , who championed innovation to combat the COVID-19 pandemic and was just as aggressive toward health equity and gun violence as a public health crisis, has been selected as Americas most influential leader in health care by Modern Healthcare.
  • View the full release here: https://www.businesswire.com/news/home/20221205005551/en/
    Northwell Health President and CEO Michael Dowling.
  • As leader of New York States largest health care provider and private employer, Mr. Dowling guided Northwell Health through the darkest days of the First Wave and then worked to upend health inequalities laid bare by the pandemic.
  • Our 81,000 employees 18,900 nurses and 4,900 employed doctors, including members of Northwell Health Physician Partners are working to change health care for the better.

First Wave BioPharma Files Investigational New Drug Application for Enhanced Microgranule Delivery Formulation of Adrulipase

Retrieved on: 
Wednesday, November 30, 2022
Digestion, Fats, Diarrhea, Weight loss, Food, PERT, AAPS, IND, FW, Acquisition, Steatorrhea, Cystic Fibrosis Foundation, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CP, Exocrine pancreatic insufficiency, Nutrient, CF, BOCA, Capsule, Niclosamide, Yarrowia, Security (finance), Gastrointestinal tract, Ulcerative colitis, Cystic fibrosis, Research, EPI, First wave, Investigational New Drug, Clinical trial, Stomach, FDA, Pharmaceutical industry

BOCA RATON, Fla., Nov. 30, 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 for gastrointestinal (GI) diseases, announced today that it has submitted an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) in human clinical trials. Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.

Key Points: 
  • Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.
  • Filing the IND is an important step in enabling First Wave to initiate the planned Phase 2 trial of our new formulation for adrulipase, said James Sapirstein, President and CEO of First Wave BioPharma.
  • In vitro data suggest the microgranule drug delivery formulation offers improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.