Yarrowia

BioInnovation Institute welcomes innovative mycoprotein meat project into Bio Studio program

Retrieved on: 
Thursday, March 9, 2023
BII, Synthetic biology, CSO, Meat, University of Washington, Pi, Metabolic engineering, Engineering, European Molecular Biology Laboratory, Research, Principal investigator, Intellectual property, Animal, EUR, Imperial College London, Taste, Health, Food, FNC, University, MVP, EMBL, Institute of technology, UN, Technical University of Denmark Department of Mathematics, Consultant, Agriculture, Yarrowia

COPENHAGEN, Denmark, March 9, 2023 /PRNewswire/ -- BioInnovation Institute (BII), an international non-profit foundation, incubating and accelerating world-class life science research, today announces that it has accepted a new project into its Bio Studio program to develop an engineered mycoprotein meat alternative.

Key Points: 
  • COPENHAGEN, Denmark, March 9, 2023 /PRNewswire/ -- BioInnovation Institute (BII), an international non-profit foundation, incubating and accelerating world-class life science research, today announces that it has accepted a new project into its Bio Studio program to develop an engineered mycoprotein meat alternative.
  • BII's Bio Studio program supports world-leading entrepreneurial Principal Investigators (PIs) who want to translate their innovative research ideas into new solutions to the benefit of planetary and human health.
  • Thus, the goal of this project is to create an initial minimum viable product (MVP) of a holistically engineered mycoprotein meat alternative.
  • The Bio Studio program is a recently established BII program with the ambition to build and run a leading life science company creation facility in Europe.

BioInnovation Institute welcomes innovative mycoprotein meat project into Bio Studio program

Retrieved on: 
Thursday, March 9, 2023
BII, Synthetic biology, CSO, Meat, University of Washington, Pi, Metabolic engineering, Engineering, European Molecular Biology Laboratory, Research, Principal investigator, Intellectual property, Animal, EUR, Imperial College London, Taste, Health, Food, FNC, University, MVP, EMBL, Institute of technology, UN, Technical University of Denmark Department of Mathematics, Consultant, Agriculture, Yarrowia

COPENHAGEN, Denmark, March 9, 2023 /PRNewswire/ -- BioInnovation Institute (BII), an international non-profit foundation, incubating and accelerating world-class life science research, today announces that it has accepted a new project into its Bio Studio program to develop an engineered mycoprotein meat alternative.

Key Points: 
  • COPENHAGEN, Denmark, March 9, 2023 /PRNewswire/ -- BioInnovation Institute (BII), an international non-profit foundation, incubating and accelerating world-class life science research, today announces that it has accepted a new project into its Bio Studio program to develop an engineered mycoprotein meat alternative.
  • BII's Bio Studio program supports world-leading entrepreneurial Principal Investigators (PIs) who want to translate their innovative research ideas into new solutions to the benefit of planetary and human health.
  • Thus, the goal of this project is to create an initial minimum viable product (MVP) of a holistically engineered mycoprotein meat alternative.
  • The Bio Studio program is a recently established BII program with the ambition to build and run a leading life science company creation facility in Europe.

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).

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.

First Wave BioPharma Engages Rho to Manage Phase 2 Clinical Trial of Enhanced Adrulipase Formulation

Retrieved on: 
Monday, October 31, 2022
Biotechnology, U.S. Securities and Exchange Commission, Marketing, Cystic fibrosis, CP, FW, Yarrowia, Acquisition, Compliance, AAPS, Research, CRO, CEO, Patient, Program, CF, ROI, EPI, Capsule, Diarrhea, Niclosamide, Company, Clinical trial, Research Triangle Park, Security (finance), Nutrient, GLOBE, Cystic Fibrosis Foundation, Exocrine pancreatic insufficiency, Food, Fats, NASDAQ, Weight loss, Drug development, BOCA, PERT, Gastrointestinal tract, First wave, Ulcerative colitis, Digestion, Stomach, Pharmaceutical industry, Rho, Facebook

First Wave BioPharma is developing adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP).

Key Points: 
  • First Wave BioPharma is developing adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP).
  • Under the agreement, Rho will manage the Phase 2 clinical trial of the microgranule drug delivery formulation of adrulipase.
  • We are eager to evaluate the potential of our new formulation in the proof-of-concept Phase 2 clinical trial, which we expect to initiate before year-end.
  • We look forward to being a valued partner to First Wave BioPharma in the management of the soon-to-be-initiated Phase 2 trial.

First Wave BioPharma Presents Research Demonstrating Benefits of Improved Adrulipase Drug Delivery Formulation at AAPS 2022 PharmSci 360

Retrieved on: 
Monday, October 10, 2022
FW, U.S. Securities and Exchange Commission, CTM, Nutrient, Weight loss, Cystic Fibrosis Foundation, Technology, IND, CP, GMP, EDT, NASDAQ, Diarrhea, Patient, Research, Investigational New Drug, Security (finance), CMC, BOCA, CF, Science, Cystic fibrosis, Company, Compliance, Acquisition, CDMO, Gastrointestinal tract, CEO, Exocrine pancreatic insufficiency, Technology company, AAPS, Food, GLOBE, Clinical trial, Stomach, Ulcerative colitis, Enteric coating, Yarrowia, First wave, Niclosamide, Fats, Digestion, List of life sciences, Poster, EPI, Pharmaceutical industry

A Phase 2 clinical trial investigating the optimized adrulipase formulation is expected to initiate before year-end 2022.

Key Points: 
  • A Phase 2 clinical trial investigating the optimized adrulipase formulation is expected to initiate before year-end 2022.
  • The poster (W0930-01-02), entitled, Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase, highlights research conducted by First Wave BioPharma and its drug delivery formulation partner, Pace Life Sciences, involving the development of a new drug delivery formulation for adrulipase.
  • Notably, the SDD04 formulation contained approximately two times higher drug load than previous formulations and retained activity even after 90 minutes under dissolution conditions.
  • We are very pleased that research into the development of a microgranule delivery formulation for adrulipase will be highlighted at the AAPS 2022 PharmSci 360 conference, said James Sapirstein, President and CEO of First Wave BioPharma.

First Wave BioPharma Finalizes Selection of Adrulipase Microgranule Drug Delivery Formulation

Retrieved on: 
Wednesday, September 7, 2022
FW, CEO, Research, Stomach, Cystic Fibrosis Foundation, Niclosamide, Nutrient, Steatorrhea, Fats, Clostridial necrotizing enteritis, U.S. Securities and Exchange Commission, CDMO, GMP, BOCA, GLOBE, Company, Patient, CP, Exocrine pancreatic insufficiency, CTM, Yarrowia, Hope, First wave, CMC, Cystic fibrosis, List of life sciences, EPI, FDA, Weight loss, Ulcerative colitis, Capsule, Trial of the century, Investigational New Drug, Security (finance), Food, Diarrhea, NASDAQ, AAPS, GI, Duodenum, PERT, Acquisition, CF, IND, CFA, Technology company, Clinical trial, Digestion, Pharmaceutical industry

BOCA RATON, Fla., Sept. 07, 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 the selection of an enhanced enteric microgranule drug delivery formulation for the ongoing development of its adrulipase clinical program (FW-EPI). First Wave BioPharma now plans to submit an Investigational New Drug (IND) amendment to the U.S. Food & Drug Administration (FDA) for a Phase 2 “proof-of-concept” clinical study investigating the optimized version of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). First Wave BioPharma expects to initiate the Phase 2 trial prior to year-end 2022 following acceptance of the IND.

Key Points: 
  • BOCA RATON, Fla., Sept. 07, 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 the selection of an enhanced enteric microgranule drug delivery formulation for the ongoing development of its adrulipase clinical program (FW-EPI).
  • First Wave BioPharma expects to initiate the Phase 2 trial prior to year-end 2022 following acceptance of the IND.
  • The selection of the enteric microgranule drug delivery technology follows extensive research by First Wave BioPharma and our drug delivery formulation partner, Pace Life Sciences, into the development and manufacturing of the optimized adrulipase formulation, said James Sapirstein, President and CEO of First Wave BioPharma.
  • Additionally, First Wave BioPharma previously published a white paper detailing the development of the microgranule formulation for adrulipase.

First Wave BioPharma Announces AAPS 2022 PharmSci 360 Accepts Adrulipase Formulation Abstract

Retrieved on: 
Wednesday, August 31, 2022
CF, Security (finance), FW, CEO, Technology, Diarrhea, Research, CP, Exocrine pancreatic insufficiency, NASDAQ, Cystic Fibrosis Foundation, AAPS, Niclosamide, Yarrowia, Nutrient, First wave, Fats, Science, Cystic fibrosis, Clostridial necrotizing enteritis, U.S. Securities and Exchange Commission, Boston Convention and Exhibition Center, List of life sciences, GMP, EPI, Digestion, BOCA, GLOBE, CDMO, Company, Weight loss, Clinical trial, Ulcerative colitis, Acquisition, Capsule, Patient, CRO, Pharmaceutical industry

BOCA RATON, Fla., Aug. 31, 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 an abstract titled, Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase, has been accepted at AAPS 2022 PharmSci 360 .

Key Points: 
  • BOCA RATON, Fla., Aug. 31, 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 an abstract titled, Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase, has been accepted at AAPS 2022 PharmSci 360 .
  • We are very pleased that First Wave and Paces research into the development of a microgranule delivery formulation for adrulipase was accepted for presentation at the AAPS 2022 PharmSci 360 conference, said James Sapirstein, President and CEO of First Wave BioPharma.
  • We are excited to report that an optimal microgranule formulation has been developed, and we now look forward to initiating a clinical trial utilizing this formulation this year.
  • 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 Provides Update on Adrulipase (FW-EPI) Clinical Program

Retrieved on: 
Thursday, January 13, 2022
PERT, Nature, Patient, International, Stomach, Niclosamide, Clinical trial, Fats, Weight loss, BOCA, Diarrhea, Nutrient, Malabsorption, NASDAQ, EPI, CEO, Absorption, Cystic Fibrosis Foundation, GLOBE, Standard of care, Cystic fibrosis, Ulcerative colitis, U.S. Securities and Exchange Commission, Acquisition, USPTO, Program, Patent, Company, Method, Digestion, Food, Yarrowia, INN, Steatorrhea, First wave, Lipase, Security (finance), Abdominal pain, Exocrine pancreatic insufficiency, International nonproprietary name, FW, Medical imaging, Pharmaceutical industry

BOCA RATON, Fla., Jan. 13, 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 provided an update on its adrulipase (FW-EPI) clinical program and advances involving adrulipase.

Key Points: 
  • BOCA RATON, Fla., Jan. 13, 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 provided an update on its adrulipase (FW-EPI) clinical program and advances involving adrulipase.
  • First Wave BioPharma has filed two new provisional patent applications pertaining to adrulipase with the U.S. Patent and Trademark Office (USPTO).
  • This is an important step in our efforts to strengthen and expand our adrulipase intellectual property portfolio as we advance the FW-EPI clinical development program, said James Sapirstein, President and CEO of First Wave BioPharma.
  • First Wave BioPharma is pursuing parallel monotherapy and combination therapy clinical pathways with adrulipase.

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.