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Enterome’s Phase 2a trial first patient dosed with Sibofimloc for Crohn's disease (CD)
23 Sep 2020
Sibofimloc (EB8018/TAK-018; FimH antagonist) – Enterome/ Takeda
- First patient has been dosed in a Phase 2a SYMMETRY clinical trial of Sibofimloc in patients with CD
- Trial details:
- Phase 2a (SYMMETRY); N= 96; TAK-018 (0.30 g or 1.5 g) or placebo, PO BD; Primary endpoints: % with endoscopic recurrence of CD; PCD: May’ 22; Recruiting; Location: US, EU
- Study will determine the safety, tolerability, and early proof of concept of Sibofimloc for the prevention of postoperative CD
- Results from this trial are expected in 2022
Enterome nears important milestone with first dosing in Phase 2a trial of Sibofimloc
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CI Scientists Remarks:
- Sibofimloc binds FimH, a novel microbiome-derived therapeutic target, to selectively disarm virulent bacteria in the gut that can cause intestinal inflammation without disrupting the local microbiome
- In 2016, Enterome in-licensed Sibofimloc from Vertex Pharmaceuticals to treat microbiome related IBD
- In 2018, Enterome entered into global licensing and co-development and co-commercialization agreement with Takeda for CD with the potential to expand to other gastrointestinal (GI) disorders and liver diseases
- Takeda will co-develop Sibofimloc and, if approved, will co-promote in the US
- Takeda will receive an exclusive license to commercialize sibofimloc ex-US, and Enterome will get royalties on net sales generated in these territories
- Sibofimloc is advancing through clinical development under this global partnership
- In a Phase 1 study, Sibofimloc was well tolerated in healthy volunteers and in patients with CD
- Enterome is planning to initiate 2 more studies for the molecule:
Indication
Phase
Expected initiations
Active CD
Phase 2
2022
2nd Indication for GI/Liver
Phase 2
2022
– Tarun Raisinghani, CI Scientists