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Also known as zotemtegrast, LY4268989
MORF-057 · 5 trials · 7 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)
| Arm | Type | Description |
|---|---|---|
| LY4268989 Study Dose 1 | EXPERIMENTAL | LY4268989 administered orally |
| LY4268989 Study Dose 2 | EXPERIMENTAL | LY4268989 administered orally |
| Placebo Study Dose | PLACEBO_COMPARATOR | Placebo administered orally |
| LY4268989 + Mirikizumab | EXPERIMENTAL | LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. |
| Mirikizumab + LY4268989 Placebo | EXPERIMENTAL | Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2. |
| 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. |
| Name | Type | Description |
|---|---|---|
| LY4268989 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Mirikizumab | DRUG | Administered IV then SC |
| LY4268989 Placebo | DRUG | Administered PO |
| MORF-057 | DRUG | MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
Inclusion Criteria: * Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC * Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by cen...
MORF-057 is an investigational oral small molecule being developed by Eli Lilly and Company for inflammatory bowel diseases, including ulcerative colitis and Crohn's disease. It is designed to target the α4β7 integrin and is currently in Phase 2 clinical development.
MORF-057 targets the α4β7 integrin, a member of the integrin class of cell adhesion receptors. By binding this integrin, the small molecule is designed to interfere with the α4β7 integrin pathway relevant to inflammatory bowel disease. It is an orally administered small molecule rather than an antibody.
MORF-057 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 2 clinical program evaluating MORF-057 in ulcerative colitis and Crohn's disease.
MORF-057 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Three Phase 2 trials have been registered, two of which are completed and one of which is currently recruiting participants.
MORF-057 has been studied in three Phase 2 trials. NCT05291689 was an open-label Phase 2a study in ulcerative colitis, and NCT05611671 was a Phase 2 study in moderately to severely active ulcerative colitis, both completed. NCT06226883 is a recruiting Phase 2 trial in moderately to severely active Crohn's disease.
MORF-057 is being developed for inflammatory bowel diseases, specifically ulcerative colitis and Crohn's disease. Its Phase 2 program includes completed studies in moderately to severely active ulcerative colitis and an ongoing study in moderately to severely active Crohn's disease in adults aged 18 and older.