Trial Outcomes & Findings for A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC (NCT NCT05291689)

Last Updated: 2025-08-14

Results Overview

Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

From baseline to 12 weeks

Results posted on

2025-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	MORF-057 MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Overall Study STARTED	35
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	MORF-057 MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	10
Overall Study Withdrawal by Subject	4

Baseline Characteristics

A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MORF-057 n=35 Participants MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	39.2 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants
Region of Enrollment Poland	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 12 weeks

Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)

Outcome measures

Outcome measures
Measure	MORF-057 n=35 Participants MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score	-6.4 score on a scale Standard Deviation 11.18

SECONDARY outcome

Timeframe: From baseline to 12 weeks

The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	MORF-057 n=35 Participants MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Change From Baseline to Week 12 in the Modified Mayo Clinic Score	-2.3 score on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: 12 weeks

To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.

Outcome measures

Outcome measures
Measure	MORF-057 n=28 Participants MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057	766 ng/mL Geometric Coefficient of Variation 46.4

SECONDARY outcome

Timeframe: 12 weeks

To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.

Outcome measures

Outcome measures
Measure	MORF-057 n=28 Participants MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057	2.014 hours Geometric Coefficient of Variation 58.4534

SECONDARY outcome

Timeframe: 12 weeks

To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.

Outcome measures

Outcome measures
Measure	MORF-057 n=27 Participants MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Area Under the Curve (AUC) Following Multiple Doses of MORF-057	3070 hours*ng/mL Geometric Coefficient of Variation 45.7

Adverse Events

MORF-057

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MORF-057 n=35 participants at risk MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Gastrointestinal disorders Colitis ulcerative	20.0% 7/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
Gastrointestinal disorders Anal fistula	5.7% 2/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
Infections and infestations Nasopharyngitis	5.7% 2/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
Infections and infestations Upper respiratory tract infection	5.7% 2/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
Infections and infestations Viral upper respiratory tract infection	5.7% 2/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
Blood and lymphatic system disorders Anaemia	8.6% 3/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
Skin and subcutaneous tissue disorders Acne	5.7% 2/35 • 52-week treatment period Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity, causality, action taken, outcomes, and whether or not it caused the participant to discontinue.

Additional Information

Head of Clinical Development

Morphic Therapeutic Inc.

Phone: 781-996-0955

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per the study protocol: "The results of this study may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission."
Publication restrictions are in place

Restriction type: OTHER