What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylates (5-ASA), glucocorticoids, and biologic agents such as anti-TNF agents and integrin inhibitors. 5-ASA medications, like mesalamine, can cause nausea, headache, fever, rash, and rarely, pancreatitis or pneumonitis. Glucocorticoids, such as prednisone, are associated with long-term side effects including osteoporosis, hypertension, diabetes, and increased risk of infections. Biologic agents, including anti-TNF agents (e.g., infliximab, adalimumab) and integrin inhibitors (e.g., vedolizumab), can lead to infusion reactions, increased risk of infections, and potential development of antibodies against the medication, which may reduce efficacy. Vedolizumab specifically has a favorable short-term safety profile but may have a slower onset of action.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Inflammatory Bowel Disease (IBD), particularly focusing on immune modulation and inflammation control. These include 5-aminosalicylates (e.g., mesalamine, sulfasalazine), glucocorticoids (e.g., prednisone, budesonide), and immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate). Biologic therapies, which are particularly relevant to treatments like MORF-057, include anti-TNF agents (infliximab, adalimumab, certolizumab pegol), anti-integrin agents (vedolizumab), and anti-IL 12/23 agents (ustekinumab). These biologics target specific components of the immune system to reduce inflammation and are commonly used in moderate to severe cases of Ulcerative Colitis and Crohn's Disease.

What other types of research exist?

Promising novel alternatives to MORF-057 for IBD patients in 2024 include: 1) OPRX-106, an orally administered recombinant TNF fusion protein shown to be safe and effective in inducing anti-inflammatory immune modulation in UC. 2) TRF-budesonide, an oral targeted-release glucocorticoid approved for reducing proteinuria in IgA nephropathy, which may have potential applications in IBD due to its targeted release in the ileocecal region. 3) Ustekinumab and Vedolizumab, biologics with demonstrated efficacy in other clinical contexts of IBD, though their role in postoperative maintenance is still being evaluated.

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Unknown

MORF-057 for Ulcerative Colitis

Phase 2

Waitlist Available

Research Sponsored by Morphic Therapeutic, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of giving signed informed consent

Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening

Must not have

Unable to attend study visits or comply with study procedures

Has a concurrent, clinically significant, serious, unstable comorbidity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called MORF-057 to see if it can help adults with serious bowel disease (Ulcerative Colitis) by reducing gut inflammation and improving symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of MORF-057 aren't listed here, common ones associated with medications for UC might include headache, nausea, abdominal pain, fatigue and potential infusion-related reactions like fever or chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to understand and sign the consent form.

Select...

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

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My ulcerative colitis extends 15 cm from the anal verge.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a serious health condition besides my cancer.

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My condition did not improve with vedolizumab or similar medications.

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I have had an allergic reaction to MORF-057 or similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MORF-057Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MORF-057

2020

Completed Phase 1

~70

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylates, glucocorticoids, immunomodulators, and biologic therapies. 5-aminosalicylates, such as mesalamine, reduce inflammation in the lining of the intestines. Glucocorticoids, like prednisone, suppress the overall immune response to decrease inflammation. Immunomodulators, such as azathioprine, alter the immune system to prevent ongoing inflammation. Biologic therapies, including infliximab and adalimumab, target specific components of the immune system, such as tumor necrosis factor (TNF), to block inflammatory pathways. These treatments are essential for IBD patients as they help manage symptoms, induce and maintain remission, and prevent complications. MORF-057, being studied for Ulcerative Colitis, likely works by modulating the immune response and reducing inflammation, similar to these established therapies, offering hope for improved disease management.

Emerging Therapies for Inflammatory Bowel Diseases.