vimekofusp (AMT-101) / Rafael Holdings - LARVOL DELTA

Applied Molecular Transport Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Applied Molecular Transport Inc...provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2022....Research and development (R&D) expenses. Research and development expenses increased by $18.4 million for the year ended December 31, 2022 compared to the year ended December 31, 2021. The overall increase was primarily driven by external costs related to the FILLMORE, LOMBARD and MARKET Phase 2 clinical trials..."

Commercial • Immunology • Inflammatory Bowel Disease

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 (ECCO-IBD 2023) - "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."

Clinical • P2 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CD163 • FOXP3 • IL10

Applied Molecular Transport Presents Additional Data from Oral AMT-101 Phase 2 FILLMORE Trial in Chronic Pouchitis at ECCO ’23 Congress (GlobeNewswire) - "Applied Molecular Transport Inc...announced additional Phase 2 data for oral AMT-101 in chronic pouchitis patients. AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, which is also in development for the treatment of rheumatoid arthritis (RA). AMT presented the data in Poster...at the European Crohn’s and Colitis Organisation (ECCO) ’23 Congress."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis (GlobeNewswire) - P2 | N=105 | LOMBARD (NCT04583358) | Sponsor: Applied Molecular Transport | "Applied Molecular Transport Inc...announced top-line Phase 2 results from the LOMBARD monotherapy trial for AMT-101 in biologic-naïve and experienced patients with moderate-to-severe ulcerative colitis (UC)....The clinical remission (CR) rate in patients treated with AMT-101 monotherapy was 17.1% (12/70 patients) compared to a CR rate of 20.0% (7/35 patients) with placebo, which was above the company’s baseline assumption for placebo CR rates based on published data in moderate-to-severe UC patients....The company plans to present full trial results at an upcoming medical conference."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Announces FDA Orphan Drug Designation Granted to AMT-101 for Treatment of Pouchitis (GlobeNewswire) - "Applied Molecular Transport Inc...announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation for AMT-101 in patients with pouchitis, an indication with significant unmet medical need and no current FDA-approved products....'Pouchitis is a severe end-stage complication of ulcerative colitis with serious symptoms that have a tremendous negative impact on quality of life, including excessive stool frequency, urgency, fecal incontinence and chronic pain...'"

Orphan drug • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "LOMBARD monotherapy trial in biologic-naïve and experienced patients with moderate-to-severe UC; trial enrollment complete and top-line data readout anticipated in late 2022 or early 2023."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) (clinicaltrials.gov) - P2a | N=105 | Active, not recruiting | Sponsor: Applied Molecular Transport | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Jun 2022 ➔ Nov 2022

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

Applied Molecular Transport Completes Enrollment of Phase 2 LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis (GlobeNewswire) - "Top-line data readout anticipated late 2022 or early 2023...Applied Molecular Transport Inc...announced the company has completed enrollment of the Phase 2 LOMBARD trial for AMT-101 in 105 patients with moderate-to-severe ulcerative colitis (UC). AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule."

Enrollment closed • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - P2 | N=22 | Completed | Sponsor: Applied Molecular Transport | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Disorder • Inflammation

Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET) (clinicaltrials.gov) - P2 | N=51 | Completed | Sponsor: Applied Molecular Transport | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Applied Molecular Transport Announces Top-line Phase 2 Results from MARKET Combination Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis (GlobeNewswire) - P2 | N=51 | "Similar clinical remission rates observed of 31.8% (7/22) in patients receiving combination (AMT-101 and adalimumab) versus 33.3% (9/27) in patients receiving placebo plus adalimumab at week 8; Post hoc analysis of patients with shorter duration of ulcerative colitis (UC) < 5 years showed clinical remission rate of 43.8% (7/16) in patients receiving combination versus 15.4% (2/13) in patients receiving adalimumab alone, suggesting combination treatment earlier in the course of disease may be beneficial...The company also anticipates top-line results from its ongoing AMT-101 Phase 2 LOMBARD monotherapy trial for UC in the second half of 2022."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Inc. (NASDAQ: AMTI) Announces Positive Results For AMT-101 Study (BioPharma Journal) - P2 | N=22 | NCT04741087(AMT-101) | Sponsor: Applied Molecular Transport | "According to a medical professor, Dr Brian Feagan, the study demonstrated that AMT-101 is safe and effective for patients with chronic pouchitis. Moreover, the drug gave remarkable results in patients with severe disease symptoms. It improved the lives of patients whose quality of life had been reduced by chronic pouchitis."

Media quote • P2 data

Applied Molecular Transport Reports First Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Three ongoing Phase 2 trials for AMT-101, a GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule: MARKET combination trial of oral AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe UC; Top-line data readout in Q2 2022."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Announces Positive Top-line Phase 2 Results from FILLMORE Trial of Oral AMT-101 in Patients with Chronic Pouchitis (GlobeNewswire) - P2 | N=22 | FILLMORE (NCT04741087) | Sponsor: Applied Molecular Transport | "Applied Molecular Transport Inc...announced positive top-line Phase 2 results from the FILLMORE monotherapy trial for AMT-101 in patients with chronic pouchitis...On the first measure, results from the trial demonstrated that 36.4% (8/22) of patients achieved stool frequency response, defined as a reduction of ≥ 3 stools and ≥ 30% from baseline, OR ≤ post-colectomy normal....On the second measure, 22.7% (5/22) of patients met the pre-specified histologic healing response of Geboes score ≤ 3.1, an objective assessment of disease improvement....The Company plans to present full trial results at an upcoming medical conference....the MARKET trial in combination with anti-TNFα for UC in the second quarter of 2022, the LOMBARD trial as a monotherapy for UC in the second half of 2022 and the CASTRO trial in combination with anti-TNFα for RA in the second half of 2022."

P2 data • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

Applied Molecular Transport Announces Publication in Tissue Barriers Providing Additional Insight into Company’s Proprietary Technology Platform (Yahoo Finance) - "Applied Molecular Transport Inc...announced that new insights into the unique mechanism of action utilized by its oral biologic product candidates, including lead clinical programs AMT-101 and AMT-126, have been published in Tissue Barriers. Oral AMT-101 and AMT-126 are in development to treat diseases associated with immune dysregulation and intestinal epithelial (IE) barrier defects, such as ulcerative colitis (UC), pouchitis and rheumatoid arthritis (RA)."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "FILLMORE monotherapy trial for patients with chronic pouchitis expected to be first top-line data readout in H1 2022. MARKET combination trial of oral AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe UC; Top-line data readout in H1 2022. LOMBARD monotherapy trial for biologic-naïve and experienced patients with moderate-to-severe UC; Top-line data readout in H2 2022."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - P2 | N=22 | Active, not recruiting | Sponsor: Applied Molecular Transport | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Disorder • Inflammation

Applied Molecular Transport Reports Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Applied Molecular Transport Inc...today provided a corporate update and reported financial results for the third quarter ended September 30, 2021....MARKET combination trial of oral AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe UC; Top-line data readout in H1 2022...Following the Company’s R&D Day event, the Company was notified of a potential imbalance in the trial’s planned 1:1 randomization. Upon confirmation of the imbalance, the Company now anticipates increasing total enrollment from 30 patients to between 40 and 50 patients. The trial has been and continues to be blinded....LOMBARD monotherapy trial for biologic-naïve and experienced patients with moderate-to-severe UC; Top-line data readout in H1 2022"

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Reports Second Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Combination trial of AMT-101 with anti-TNFα in moderate-to-severe ulcerative colitis (UC) patients in the fourth quarter of 2021...Enrollment ongoing in four Phase 2 trials for AMT-101, a GI-selective, oral IL-10 fusion: MARKET combination trial of oral AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe UC...LOMBARD monotherapy trial for biologic-naïve and experienced patients with moderate-to-severe UC...Top-line data readouts from four oral AMT-101 Phase 2 trials in Q4 2021 and into 2022."

Enrollment status • New trial • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Presents Additional Positive Data from Oral AMT-101 Phase 1b in Ulcerative Colitis at ECCO ‘21 Virtual Congress (GlobeNewswire) - P1b, N=52; AURIGA1 (NCT04224857); Sponsor: Applied Molecular Transport; "Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials, being conducted in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021 and into 2022...Applied Molecular Transport Inc...today announced additional Phase 1b data for oral AMT-101 in ulcerative colitis (UC) patients...AMT presented the data in ePoster P294 AMT-101, a gut selective oral IL-10 fusion: results from a Phase 1b study in patients with active Ulcerative Colitis at the European Crohn’s and Colitis Organisation (ECCO) ‘21 Virtual Congress."

P1 data • P2 data • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) (clinicaltrials.gov) - P2a; N=102; Recruiting; Sponsor: Applied Molecular Transport; Trial completion date: Mar 2022 ➔ Jun 2022; Trial primary completion date: Feb 2022 ➔ Jun 2022

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

[VIRTUAL] AMT-101, a gut selective oral IL-10 fusion: results from a Phase 1b study in patients with active Ulcerative Colitis (ECCO-IBD 2021) - "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."

Clinical • P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL10

Applied Molecular Transport Reports First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Received acceptance for our submission to present the full AMT-101 Phase 1b multiple ascending dose UC data set at the ECCO’21 Virtual Congress in July 2021...Anticipated Upcoming Milestones: Top-line data readouts from the four oral AMT-101 Phase 2 trials beginning in 2H 2021 and into 2022."

P1 data • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Applied Molecular Transport Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "Successfully initiated four planned Phase 2 trials for oral AMT-101 with enrollment ongoing. Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program, in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021."

Enrollment status • P2 data • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

FILLMORE: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Applied Molecular Transport; Trial primary completion date: Mar 2021 ➔ Mar 2022

Clinical • Trial primary completion date