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- AMT-101 / Applied Molecular Transport
Efficacy, safety, and tolerability of AMT-101, a gut selective oral IL-10 fusion, in the Phase 2 FILLMORE trial of patients with chronic pouchitis (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_1383;
PK and translational data confirmed AMT-101's gut-restricted profile over the 12-week treatment with tissue-level PD effects and no systemic exposure. The AMT-101 3 mg dose is advancing into a Phase 3 trial for chronic pouchitis.
- || AMT-101 / Applied Molecular Transport
Enrollment closed, Trial completion date, Trial primary completion date: Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) (clinicaltrials.gov) - Nov 7, 2022
P2a, N=105, Active, not recruiting, Sponsor: Applied Molecular Transport
The AMT-101 3 mg dose is advancing into a Phase 3 trial for chronic pouchitis. Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Nov 2022
- ||| AMT-101 / Applied Molecular Transport
Trial completion, Combination therapy: Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET) (clinicaltrials.gov) - Sep 14, 2022
P2, N=51, Completed, Sponsor: Applied Molecular Transport
Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Nov 2022 Active, not recruiting --> Completed
- || AMT-101 / Applied Molecular Transport
Trial completion: FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - Sep 14, 2022
P2, N=22, Completed, Sponsor: Applied Molecular Transport
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || AMT-126 / Applied Molecular Transport
New P1 trial: SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects (clinicaltrials.gov) - Jul 27, 2022
P1, N=50, Completed, Sponsor: Applied Molecular Transport
- | AMT-101 / Applied Molecular Transport
Enrollment closed: FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - Feb 16, 2022
P2, N=22, Active, not recruiting, Sponsor: Applied Molecular Transport
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || AMT-101 / Applied Molecular Transport
Trial completion date, Trial primary completion date: Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) (clinicaltrials.gov) - Jul 8, 2021
P2a, N=102, Recruiting, Sponsor: Applied Molecular Transport
Recruiting --> Active, not recruiting Trial completion date: Mar 2022 --> Jun 2022 | Trial primary completion date: Feb 2022 --> Jun 2022
- AMT-101 / Applied Molecular Transport
[VIRTUAL] AMT-101, a gut selective oral IL-10 fusion: results from a Phase 1b study in patients with active Ulcerative Colitis (Virtual Poster Exhibition) - May 5, 2021 - Abstract #ECCOIBD2021ECCO_IBD_535;
Doses at 10 mg or less suggest potential clinical efficacy paired with an enhancement of favorable enteric commensal bacteria after only 14 days of treatment. These findings support AMT-101 as actively exerting an immunomodulatory effect in the intestinal lamina propria and support ongoing Ph2 trials of AMT-101.
- | AMT-101 / Applied Molecular Transport
Journal: A Novel Fusion of IL-10 Engineered to Traffic across Intestinal Epithelium to Treat Colitis. (Pubmed Central) - Apr 14, 2021
Oral gavage of AMT-101 in two mouse models of induced colitis prevented associated pathological events and plasma cytokine changes. Overall, these studies suggest that AMT-101 can efficiently overcome the epithelial barrier to focus biologically active IL-10 to the intestinal lamina propria.
- | AMT-101 / Applied Molecular Transport
Trial primary completion date: FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - Mar 4, 2021
P2, N=20, Recruiting, Sponsor: Applied Molecular Transport
Overall, these studies suggest that AMT-101 can efficiently overcome the epithelial barrier to focus biologically active IL-10 to the intestinal lamina propria. Trial primary completion date: Mar 2021 --> Mar 2022
- || AMT-101 / Applied Molecular Transport
New P2 trial: FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - Feb 4, 2021
P2, N=20, Recruiting, Sponsor: Applied Molecular Transport
- || AMT-101 / Applied Molecular Transport
Clinical, Journal: Less Blood Loss by Earlier Oxytocin Infusion in Cesarean Sections? A Randomized Controlled Trial. (Pubmed Central) - Jan 9, 2021
Our findings suggest that the starting IV oxytocin infusion early before uterine incision reduces intraoperative blood loss. This could be effective to replace starting IV oxytocin infusion late after umbilical cord clamping or delivery of the placenta.
- || AMT-101 / Applied Molecular Transport
New P2 trial: A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy (EUDRACT) - Dec 22, 2020
P2, N=20, Ongoing, Sponsor: Applied Molecular Transport Inc.
- ||| AMT-101 / Applied Molecular Transport
Trial completion, Trial completion date, Trial primary completion date: AURIGA1: SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 (clinicaltrials.gov) - Oct 28, 2020
P1, N=52, Completed, Sponsor: Applied Molecular Transport
This could be effective to replace starting IV oxytocin infusion late after umbilical cord clamping or delivery of the placenta. Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Apr 2020 | Trial primary completion date: Aug 2020 --> Apr 2020
- |||| AMT-101 / Applied Molecular Transport
New P2a trial: Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) (clinicaltrials.gov) - Oct 11, 2020
P2a, N=102, Recruiting, Sponsor: Applied Molecular Transport
- || AMT-101 / Applied Molecular Transport
Enrollment closed: AURIGA1: SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 (clinicaltrials.gov) - Apr 16, 2020
P1, N=60, Active, not recruiting, Sponsor: Applied Molecular Transport
Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Apr 2020 | Trial primary completion date: Aug 2020 --> Apr 2020 Recruiting --> Active, not recruiting
- AMT-101 / Applied Molecular Transport
Treatment of ulcerative colitis With AMT-101, a novel oral interleukin-10 immunomodulatory fusion biologic that traffics across the intestinal epithelium (Plenary Hall) - Dec 3, 2019 - Abstract #ECCOIBD2020ECCO_IBD_95;
Importantly, the gut-selective nature of the responses observed suggests AMT-101 may alleviate the previous issues of dose-limiting side effects observed with systemic administration of IL-10 and point to the intestinal lamina propria as a critical site of IL-10’s immunomodulatory actions. AMT-101 has advanced to the clinic and is currently being evaluated in a Phase1b trial in patients with active ulcerative colitis.