niclosamide (FW-UP) / Entero Therap - LARVOL DELTA

A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis (clinicaltrials.gov) - P1/2 | N=27 | Terminated | Sponsor: First Wave Bio, Inc. | N=56 ➔ 27 | Active, not recruiting ➔ Terminated; Covid-19

Enrollment change • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis (clinicaltrials.gov) - P1/2 | N=56 | Active, not recruiting | Sponsor: First Wave Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

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

First Wave BioPharma Forms Clinical Steering Committee Focused on Advancing Inflammatory Bowel Disease (IBD) Product Portfolio (GlobeNewswire) - "First Wave BioPharma, Inc...announced the formation of a clinical steering committee focused on advancing the Company’s inflammatory bowel disease (IBD) product portfolio, including FW-UP (ulcerative proctitis and ulcerative proctosigmoiditis), FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease). First Wave BioPharma is currently advancing a Phase 2 clinical trial investigating FW-UP, a topical formulation of niclosamide, for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS)."

Clinical • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: First Wave Bio, Inc.; Trial completion date: Dec 2021 ➔ Oct 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

First Wave BioPharma Announces Restructuring of Merger Consideration Payment Terms With Former Shareholders of First Wave Bio (GlobeNewswire) - "The milestone payment of $2 million, triggered upon first patient dosed in the FW-UP Phase 2 clinical trial for ulcerative proctitis...is being paid immediately and concurrent with the signing of the Revised Merger Agreement."

Commercial • Inflammatory Bowel Disease • Ulcerative Colitis

First Wave BioPharma Announces Dosing of First Patient in Phase 2b Clinical Trial Evaluating Topical Niclosamide in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis (GlobeNewswire) - "First Wave BioPharma, Inc...announced that it has dosed the first patient in a Phase 2b clinical trial investigating a topical formulation of niclosamide (FW-UP) as a potential treatment for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). The Phase 2b trial is a placebo-controlled study that will enroll up to 28 patients to compare FW-UP, administered as an enema twice daily at a dose of 450 mg, to placebo enemas twice daily. Patient screening is underway at clinical trial sites in Italy and will start soon in Austria and Germany. First Wave BioPharma is also planning a separate clinical trial to investigate an oral formulation of niclosamide as a potential treatment for pancolitis."

Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

First Wave BioPharma Begins Patient Screening for Phase 2b Clinical Trial Evaluating Niclosamide in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis (GlobeNewswire) - P1/2, N=NA; "First Wave BioPharma, Inc...announced that it has begun screening patients for enrollment in a Phase 2b clinical trial investigating a topical formulation of FW-UP as a potential treatment for ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS)...UP and UPS are two types of ulcerative colitis, a chronic inflammatory bowel disease (IBD) consisting of fine ulcerations in the inner mucosal lining of the large intestine that do not penetrate the bowel muscle wall...Patient screening is underway at clinical trial sites in Italy and will start soon in Austria and Germany...Data from the first 17 patients treated in the low-dose cohort demonstrated niclosamide to be well tolerated, with a durable therapeutic effect and a clinical remission rate of 59%."

New P2b trial • P1/2 data • Inflammatory Bowel Disease • Ulcerative Colitis