adrulipase alfa (FW-EPI) / Entero Therap - LARVOL DELTA

SPAN: Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: First Wave BioPharma, Inc. | Recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Jun 2023

Trial completion • Trial completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

First Wave BioPharma Announces Initial Topline Results from Phase 2 SPAN Clinical Trial Investigating Enhanced Adrulipase Formulation (GlobeNewswire) - P2 | N=12 | SPAN (NCT05719311) | Sponsor: First Wave BioPharma, Inc. | "First Wave BioPharma...today announced the Company has received topline results from the Company’s Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase....The primary efficacy endpoint is the coefficient of fat absorption (CFA)...First Wave BioPharma anticipates conducting the End-of-Phase 2 meeting in the fourth quarter of 2023."

FDA event • P2 data • Cystic Fibrosis • Pancreatitis

First Wave BioPharma Announces Final Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation (GlobeNewswire) - "First Wave BioPharma...today announced that the final patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF)....Topline results from the study are anticipated by mid-2023."

P2 data • Trial status • Cystic Fibrosis • Pancreatitis

First Wave BioPharma to Attend the 36th National Cystic Fibrosis Education Conference (July 28-30) (GlobeNewswire) - "First Wave BioPharma...announced that it will attend the Cystic Fibrosis Research Institute’s (CFRI) 36th National Cystic Fibrosis Education Conference being held July 28-30, 2023, at the Grand Bay Hotel San Francisco in Redwood City, California.During the conference, members of the First Wave BioPharma management team will be available to discuss the anticipated July 2023 topline data from the company’s Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF)."

P2 data • Cystic Fibrosis • Genetic Disorders

FIRST WAVE BIOPHARMA REACHES ENROLLMENT TARGET FOR PHASE 2 SPAN ADRULIPASE CLINICAL TRIAL IN CYSTIC FIBROSIS (GlobeNewswire) - "First Wave BioPharma...today announced that it has achieved the enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF)....The majority of patients in the study have completed dosing and the remaining patients are currently being dosed. We remain on track to report topline data in July 2023."

Enrollment status • P2 data • Cystic Fibrosis • Pancreatitis

RESULTS FROM AN OPEN-LABEL, PHASE 2 STUDY WITH ESCALATING DOSES OF ADRULIPASE ALFA ON TOP OF A STABLE DOSE OF PORCINE PANCREATIC ENZYMES (PPE) IN CF PATIENTS NOT FULLY COMPENSATED WITH PPE AS SOLE THERAPY (DDW 2023) - "Escalating doses of adrulipase (700 mg/day – 2240 mg/day) on top of a stable dose of PPEs resulted in a clinically significant increase of the mean CFA (Brady et al, 2006), in addition to improvements in signs, symptoms and nutritional status. Adrulipase was safe and well tolerated when administered in escalating doses up to 2240 mg/day. The results of this study support further studies of this product in patients currently not well controlled on PPE alone."

P2 data • Preclinical • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pancreatitis • Pulmonary Disease • Respiratory Diseases

First Wave BioPharma Completes Patient Screening For Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis (GlobeNewswire) - "First Wave BioPharma...today announced that it has completed patient screening in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF)....We plan to announce completion of patient enrollment shortly and remain on track to report topline data in July 2023."

Enrollment status • P2 data • Cystic Fibrosis

First Wave Biopharma Exceeds 50% Enrollment Target for Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis (GlobeNewswire) - "First Wave BioPharma, Inc...announced that it has now surpassed the 50% enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF)."

Enrollment status • Cystic Fibrosis • Genetic Disorders

First Wave BioPharma Announces Second Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation in Cystic Fibrosis (GlobeNewswire) - "First Wave BioPharma, Inc...announced that the second patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The three U.S. clinical trial sites participating in the trial are now actively screening and enrolling patients."

Trial status • Cystic Fibrosis • Genetic Disorders

First Wave BioPharma Announces First Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation (GlobeNewswire) - "First Wave BioPharma, Inc...announced that the first patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Topline results from the study are anticipated by mid-2023. The Phase 2 multi-center clinical trial...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. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Three clinical trial sites in the U.S. will be participating in the trial."

Trial status • Cystic Fibrosis • Genetic Disorders

First Wave BioPharma Announces Phase 2 Adrulipase Combination Trial Data to be Presented at the 2023 Digestive Disease Week (DDW) Conference (GlobeNewswire) - "First Wave BioPharma, Inc...announced that an abstract...has been accepted for a presentation at the 2023 Digestive Disease Week Conference (DDW 2023). The conference is taking place May 6-9, 2023, in Chicago. The presentation by Michael Konstan, M.D., Vice Dean for Translational Research at Case Western Reserve University School of Medicine and a clinical expert in exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF), will share data from the Phase 2 adrulipase Combination Therapy Trial which evaluated the safety and efficacy of adrulipase in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe EPI in patients with CF."

P2 data • Cystic Fibrosis • Genetic Disorders

SPAN: Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: First Wave Bio, Inc.

New P2 trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

First Wave BioPharma Announces First Patient Screened for Phase 2 SPAN Adrulipase Trial in Cystic Fibrosis (GlobeNewswire) - "First Wave BioPharma...today announced that the first patient was screened for the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Patient dosing is expected to commence by mid-February with topline results from the study to be available by mid-2023....The Phase 2 multi-center clinical trial 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. The primary efficacy endpoint is the coefficient of fat absorption (CFA)...'"

P2 data • Trial status • Cystic Fibrosis

First Wave BioPharma Announces Initiation of Phase 2 Trial Investigating Enhanced Adrulipase Formulation in Exocrine Pancreatic Insufficiency in Patients with Cystic Fibrosis (GlobeNewswire) - "First Wave BioPharma, Inc...announced that the Company will initiate its planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug (IND) amendment and after requesting and receiving a modified protocol, has not provided any further comments in the 60 day period of review....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. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA)."

IND • New P2 trial • Cystic Fibrosis • Genetic Disorders

First Wave BioPharma Announces Initial Clinical Sites for its Phase 2 Trial of Enhanced Microgranule Delivery Formulation of Adrulipase (GlobeNewswire) - "First Wave BioPharma, Inc...announced today that it has selected the initial clinical trial sites for its planned Phase 2 clinical trial 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). Based on anticipated regulatory and clinical trial activities, First Wave BioPharma expects to report topline data from the Phase 2 trial by mid-2023."

New P2 trial • P2 data • Cystic Fibrosis • Genetic Disorders • Pancreatitis

First Wave BioPharma Files Investigational New Drug Application for Enhanced Microgranule Delivery Formulation of Adrulipase (GlobeNewswire) - "First Wave BioPharma...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....'If the FDA grants authorization in the next 30 days, we expect to start the study in early 2023 with topline data anticipated towards the end of the first half of 2023.'"

IND • New P2 trial • P2 data • Cystic Fibrosis • Genetic Disorders • Pancreatitis

First Wave BioPharma Engages Rho to Manage Phase 2 Clinical Trial of Enhanced Adrulipase Formulation (GlobeNewswire) - "First Wave BioPharma...announced today that it has entered into an agreement with Rho...for its planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase. 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."

Licensing / partnership • Cystic Fibrosis • Pancreatitis

First Wave BioPharma Presents Research Demonstrating Benefits of Improved Adrulipase Drug Delivery Formulation at AAPS 2022 PharmSci 360 (GlobeNewswire) - "First Wave BioPharma...announced today that research demonstrating key advantages of its improved adrulipase drug delivery formulation will be the subject of a poster presentation at AAPS 2022 PharmSci 360 on October 19 at 9:30 a.m., EDT....The poster (W0930-01-02), entitled, 'Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase,'...In vitro data suggest the formulation (SDD04), which was compared against eight other formulations of adrulipase, has the potential to offer the best protection against the acidic pH in the stomach followed by rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit....We are now in the process of completing the Investigational New Drug (IND) application for a proposed Phase 2 clinical trial of this optimized formulation is expected to initiate before year-end 2022."

IND • Preclinical • Cystic Fibrosis • Pancreatitis

First Wave BioPharma Finalizes Selection of Adrulipase Microgranule Drug Delivery Formulation (GlobeNewswire) - "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."

IND • New P2 trial • Cystic Fibrosis • Pancreatitis

First Wave BioPharma, Inc. (BIO 2022) - "First Wave is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. The Company has recently completed enrollment in a Phase 2 clinical trial for COVID-GI infection, is advancing a Phase 2 study in ulcerative colitis-proctitis, and preparing to initiate a Phase 2 trial for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis."

Cystic Fibrosis • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Ulcerative Colitis

Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs (clinicaltrials.gov) - P2; N=20; Completed; Sponsor: AzurRx SAS; Recruiting ➔ Completed

Clinical • Trial completion • Cystic Fibrosis • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE

AzurRx BioPharma Announces Positive Topline Data For Phase 2 MS1819 Combination Therapy Trial in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency (EPI) (GlobeNewswire) - P2, N=20; NCT04302662; Sponsor: AzurRx SAS; "AzurRx BioPharma...announced positive topline results from its Phase 2 Combination Trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency in patients with cystic fibrosis (CF)....Data collected from 20 patients indicated that MS1819 in combination with PERT led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption....AzurRx is now developing a new enteric-coated microbead formulation for MS1819 and plans to initiate a bridging study in 2022 evaluating the formulation as a single-agent therapy...'From baseline, CFA increased by 6.57%, mean body weight increased by 3.75 pounds, stool weight decreased by 164 grams/day and the mean daily number of stools decreased by 0.43."

New trial • P2 data • Cystic Fibrosis

AzurRx BioPharma Announces WHO Publication of “Adrulipase Alfa” as International Nonproprietary Name for MS1819 (GlobeNewswire) - "AzurRx BioPharma...today announced the World Health Organization (WHO) has published 'adrulipase alfa' as the proposed International Nonproprietary Name (INN) for MS1819....AzurRx is pursuing parallel monotherapy and combination therapy clinical pathways with MS1819...expects to report full topline results from its Phase 2 combination therapy trial, evaluating MS1819 in combination with PERT, for the treatment of severe EPI in patients with cystic fibrosis, in the third quarter of 2021....The WHO is expected to render a final decision on the use of adrulipase alfa for MS1819 by November 2021."

Clinical • P2 data • Cystic Fibrosis

OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis (clinicaltrials.gov) - P2; N=27; Completed; Sponsor: AzurRx BioPharma, Inc.; Recruiting ➔ Completed

Trial completion • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] AzurRx BioPharma (BIO 2021) - "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, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California."

Cystic Fibrosis • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Pancreatitis • Pulmonary Disease • Respiratory Diseases