• Niclosamide
  Pre-IND

  Phase 1

  Phase 2

  Phase 3
• Ulcerative Proctitis and
  Ulcerative Proctosigmoiditis

   

   

   

   

  FW-UP (niclosamide)

  Description: FW-UP is a niclosamide-based, oral small molecule anti-inflammatory inhibitor therapy for the treatment of ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). FW-UP is currently being investigated in a Phase 2b clinical trial study to study the safety and potential efficacy of niclosamide in patients with UP and UPS. FW-UP has the potential to safely treat UP and UPS, 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. UPS causes inflammation in the colon and rectum, while UP is confined only to the rectum. Symptoms include weight loss, fatigue, abdominal pain and cramps, rectal pain and bleeding, and diarrhea, although constipation can also develop as the body struggles to maintain normal bowel function. UP and UPS can occur at any point throughout life, with a high occurrence in young children and then again around 40-50 years of age. Progression of this disease to ulcerative colitis, extending farther up the bowel to involve the sigmoid colon, occurs in about 30-50% of patients. Although there is a range of treatments to help ease symptoms and induce remission, there is no cure. Preliminary results from a low-dose cohort of 17 subjects demonstrated FW-UP to be well tolerated, with a durable therapeutic effect. A high dose cohort of the Phase 2a study is currently enrolling. Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.

• Grades 1 and 2 Immune Checkpoint Inhibitor-Associated Colitis

   

   

   

   

  FW-ICI-AC (niclosamide)*

  Description: FW-ICI-AC is a niclosamide-based, oral, small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor (ICI)-associated colitis and diarrhea in metastatic cancer patients. The PASSPORT clinical trial, a Phase 2a study to determine the safety and potential efficacy of niclosamide in the treatment of ICI-AC, received FDA IND clearance in Q4 2021. Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs was over $22 billion in 2019 and growing rapidly. The incidence of immune-mediated colitis (IMC) ranges from 1% to 25% depending on the type of ICI and whether they are used in combination. Up to 30% of ICI patients develop diarrhea, which can progress to colitis. For example, between 25% and 30% of patients taking ipilimumab (Yervoy) developed diarrhea and roughly 8% to 12% developed colitis. FW-ICI-AC has the potential to safely treat Grade 1 and Grade 2 ICI-associated colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable advanced oncology patients to remain on, or spend minimal time off, their ICI treatment programs without interruption. Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.

_*Anticipated