Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MORF-057 · 4 trials · 4 indications
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
Subject incidence of adverse events and serious adverse events
Cmax (Food Effect cohort)
Tmax (Food Effect cohort)
| Arm | Type | Description |
|---|---|---|
| Group 1 (Part A) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 2 (Part A) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 3 (Part A) | PLACEBO_COMPARATOR | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 4 (Part B) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 5 (Part B) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 6 (Part B) | PLACEBO_COMPARATOR | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| MORF-057 200 mg BID | EXPERIMENTAL | Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks. |
| MORF-057 100 mg BID | EXPERIMENTAL | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. |
| MORF-057 100 mg QD-M | EXPERIMENTAL | Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received an oral dose of matching placebo for 12 weeks. |
| MORF-057 | EXPERIMENTAL | Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks. |
| Placebo for MORF-057 | EXPERIMENTAL | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo (identical appearance to MORF-057) administered orally. |
| MORF-057 | DRUG | MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
| Placebo for MORF-057 | DRUG | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. |
Key Inclusion Criteria: * Has signs/symptoms of CD for at least 90 days prior to screening * Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points * Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is iso...
MORF-057 is an investigational small molecule being developed for inflammatory bowel diseases, including ulcerative colitis and Crohn's disease. It is also studied in healthy volunteers for early-phase safety trials. MORF-057 is not approved and remains in clinical development.
MORF-057 is developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company is conducting multiple clinical trials of MORF-057 in inflammatory bowel diseases.
MORF-057 is in Phase 2 clinical development. Early Phase 1 studies in healthy volunteers are completed, and Phase 2 trials in ulcerative colitis and Crohn's disease are ongoing or completed. MORF-057 is investigational and not FDA approved.
MORF-057 has three registered trials. NCT04580745, a completed Phase 1 study in healthy volunteers. NCT05291689, a completed Phase 2a open-label study in ulcerative colitis. NCT05611671, an active Phase 2 study in moderately to severely active ulcerative colitis. NCT06226883, a recruiting Phase 2 study in Crohn's disease.
Yes, MORF-057 is being studied in ulcerative colitis. A Phase 2a open-label study (NCT05291689) is completed, and a larger Phase 2 study (NCT05611671) in moderately to severely active ulcerative colitis is active but not recruiting. Both enrolled adults aged 18 years and older.
Yes, MORF-057 is being studied in Crohn's disease. A Phase 2 study (NCT06226883) is currently recruiting adults with moderately to severely active Crohn's disease. The trial is enrolling participants across multiple countries, including the United States, Japan, and European nations.