Product CandidateIndicationPreclinicalPhase 1Phase 2Phase 3
(mild-to-moderate)In Phase 1b/2a
(Oral and Rectal)Checkpoint-induced colitis
There is no cure for these conditions, and patients face difficult choices. The medicines designated for milder cases are not effective for many, and those prescribed for more severe cases have significant limitations and health risks. Immunosuppressive IBD drugs are particularly challenging for patients with checkpoint-induced colitis, as they may reduce the efficacy of their cancer treatments. We believe we can deliver a new paradigm: Highly targeted small molecules that kill pathogenic cells in the gut while leaving healthy cells untouched and without systemic immunosuppression.
Addressing Vast Unmet Need in Mild-to-Moderate IBD
In the U.S. alone, about 1.1 million individuals live with mild-to-moderate UC, masking symptoms and pain as best as possible with existing treatments. Anti-inflammatory compounds commonly prescribed to them fail to induce remission in 58% of UC patients when administered orally and 50% when administered rectally1. Corticosteroids can control flare-ups, but they carry a risk of toxicity that limits their long-term use. Immunomodulators can be effective over time for some patients who do not respond to other treatment options, but they have additional risks that limit their utility for many.
Addressing the COVID-19 Pandemic
We have been moving with great urgency since the emergence of COVID-19 to explore the potential of our MetaWave platform of oral gut-targeted medicines to address the underlying pathophysiology of the disease. With insights emerging into the crucial role of the gastrointestinal (GI) tract in COVID-19 severity and transmission, the company is accelerating clinical development of FW-1022 to meet the urgent need for new strategies to combat the virus. FW-1022 is a proprietary oral formulation of Niclosamide, an FDA-approved anthelminthic drug with broad spectrum antiviral properties that is currently listed on the World Health Organization’s list of essential medicines.
We are currently scaling drug manufacturing and engaging with regulatory agencies to initiate a clinical trial of oral MetaWave, FW-1022, in patients with COVID-19. We expect to initiate the clinical trial in the EU in mid-2020 and to initiate a U.S. clinical trial shortly thereafter.
Addressing Checkpoint-Induced Colitis and Mild-to-Moderate Crohn’s Disease
We expect to bring our MetaWave product candidates to cancer patients with checkpoint-induced colitis and to people living with mild-to-moderate Crohn’s disease for which there are no approved treatments. For cancer patients with checkpoint-induced colitis, the colitis can limit their ability to receive higher therapeutic doses to treat their cancer, and immunosuppressive drugs to treat colitis can limit their response to cancer therapy. Checkpoint-induced colitis can also progress rapidly and lead to death.
MetaWave product candidates have the potential to improve upon and expand the use of checkpoint inhibitors to treat cancer. Individuals with moderate-to-severe IBD are typically treated with anti-TNFs and other biologics that carry significant systemic side effects. The 30-50% of patients who do not respond to biologics may progress in disease severity and require a colectomy.
1. Source: Ford, A.C., Khan, K. J., Achkar, J. P., & Moayyedi, P. (2012). Efficacy of oral vs. topical, or combined oral and topical 5-aminosalicylates, in Ulcerative Colitis: systemic review and metaanalysis. American Journal of Gastroenterology, 107(2), 167-176. doi:10.1038/ajg.2011.410.