MORF-057 for Ulcerative Colitis

(EMERALD-1 Trial)

No longer recruiting at 23 trial locations

Overseen By Morphic Therapeutic, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Disqualifiers: Crohn's disease, Serious comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MORF-057 for individuals with moderately to severely active ulcerative colitis (UC), a condition causing inflammation and sores in the digestive tract. The goal is to determine if MORF-057 is safe and effective in reducing UC symptoms. It targets those who have experienced UC symptoms for at least three months without relief from other treatments. Participants should have UC affecting at least 15 cm of their colon. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the MORF-057 trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that MORF-057 is likely to be safe for humans?

Research has shown that MORF-057 is generally well tolerated by people with ulcerative colitis. Studies have found no major side effects, indicating that most participants did not experience serious problems. Early results suggest that MORF-057 could be a promising option for those with this condition. Overall, current evidence indicates that the treatment appears safe and effective. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MORF-057 is unique because it targets ulcerative colitis in a novel way by focusing on a specific protein involved in inflammation. Unlike current standard treatments, which often include anti-inflammatory drugs like mesalamine or immune system suppressants such as corticosteroids, MORF-057 works differently by aiming at the mechanism of inflammation itself. Researchers are excited about this treatment because it has the potential to offer a more targeted approach, possibly leading to better outcomes with fewer side effects.

What evidence suggests that MORF-057 might be an effective treatment for ulcerative colitis?

Research has shown that MORF-057, the investigational treatment in this trial, may help treat ulcerative colitis (UC). In one study, 25.7% of patients had healthier-looking colons during an exam, and 45.7% of participants noticed symptom improvement after 12 weeks. Another study found that 22.9% of patients experienced reduced inflammation and healing. These results suggest MORF-057 could be a promising option for those with moderately to severely active UC. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with moderately to severely active Ulcerative Colitis (UC) that's been present for at least 3 months. Participants must have UC extending 15 cm from the anal verge and may be new to treatment or unresponsive/intolerant to other UC drugs. They should not have Crohn's disease, certain colitis types, neurological issues on screening, previous MORF-057 exposure or hypersensitivity, serious health problems, or recent participation in another study.

Inclusion Criteria

I am able to understand and sign the consent form.

I have had moderate to severe ulcerative colitis symptoms for at least 3 months.

I have not tried or did not respond well to other ulcerative colitis drugs.

Exclusion Criteria

I cannot attend the study visits or follow the study procedures.

I have a serious health condition besides my cancer.

My condition did not improve with vedolizumab or similar medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MORF-057 for 12 weeks to evaluate efficacy, safety, and tolerability

12 weeks

Multiple visits for blood sampling and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension

Participants may opt into continuation of treatment for an additional 26 weeks

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MORF-057

Trial Overview The trial is testing MORF-057's effectiveness and safety in treating Ulcerative Colitis. It’s an open-label Phase 2a study where all participants receive the drug; there are no comparison groups. The goal is to see how well it works and what side effects occur when given to people with moderate-to-severe UC.

How Is the Trial Designed?

Group I: MORF-057 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Lead Sponsor

Morphic Therapeutic, Inc

Lead Sponsor

Trials

4

Recruited

590+

Published Research Related to This Trial

The newer formulations of 5-aminosalicylic acid (5-ASA) were found to be significantly more effective than placebo in inducing remission in active ulcerative colitis, with a pooled odds ratio of 0.51, indicating a lower failure rate in achieving clinical improvement.

While 5-ASA showed a trend towards better outcomes compared to sulfasalazine (SASP), the difference was not statistically significant, and 5-ASA was better tolerated, suggesting it may be a preferable option despite potential cost considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. Sutherland, L., Roth, D., Beck, P., et al.[2018]

Citations

1. cghjournal.org cghjournal.org/article/S1542-3565(25)00648-2/fulltext

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... These initial results suggest that MORF-057 is a potentially safe and effective advanced oral therapy for ulcerative colitis, suitable for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40769468/

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... Additionally, 22.9% of participants (8/35) achieved RHI remission (RHI score ≤3). In participants with evaluable data (n = 18), the effects of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1542356525006482

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... These initial results suggest that MORF-057 is a potentially safe and effective advanced oral therapy for ulcerative colitis, suitable for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07186101

Study Details | NCT07186101 | LY4268989 (MORF-057) ... The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult ...

5. hcplive.com hcplive.com/view/-of-patients-achieve-endoscopic-remission-in-phase-2a-emerald-1-trial-for-morf-057

25% of Patients Achieve Endoscopic Remission in Phase ... Data from the phase 2a trial showed 25.7% of patients with UC demonstrated endoscopic improvement and 45.7% achieved clinical response after week 12.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05291689

NCT05291689 | A Phase 2a Open-Label Study to Evaluate ... This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately ...

7. crohnscolitisfoundation.org crohnscolitisfoundation.org/a-phase-2b-randomized-double-blind-placebo-controlled-study-to-evaluate-the-safety-and-efficacy-of

A Phase 2b, Randomized, Double-blind, Placebo ... To date, there have been no significant adverse events reported in clinical studies with MORF-057. The study drug may cause all, some, or none ...