Morphic Therapeutic to Host EMERALD-1 Topline Results Call on April 25, 2023

Rhea-AI Summary

Morphic Therapeutic will host a conference call on April 25, 2023, to discuss topline results from the EMERALD-1 Phase 2a study of MORF-057 in adults with moderate to severe ulcerative colitis. The study includes a main cohort of 35 patients treated with 100 mg BID. The primary endpoint evaluated the change in the Robarts Histopathology Index (RHI) after 12 weeks, assessing histological disease activity. The trial aims to demonstrate the efficacy, safety, and tolerability of MORF-057, a selective oral inhibitor of the α4β7 integrin, which has shown promise in targeting inflammatory bowel disease. A live webcast will be available on the company’s website, and an archived replay will follow.

Positive

• MORF-057 targets the α4β7 integrin, validated by the success of vedolizumab.
• The trial assesses a well-defined primary endpoint using RHI to measure disease activity.
• Patient cohort of 35 treated suggests comprehensive data collection for analysis.

Negative

• No specific topline results or data are reported in the PR, leaving uncertainties about the study's outcome.

Call to discuss topline data from EMERALD-1 Phase 2a study of MORF-057 in adults with moderate to severe ulcerative colitis

WALTHAM, Mass., April 24, 2023 (GLOBE NEWSWIRE) -- Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced it will host a webcast and conference call to discuss topline results from the main cohort of the open-label EMERALD-1 Phase 2a study of MORF-057 in adults with moderate to severe ulcerative colitis. The webcast and conference call will be held at 8:00 AM Eastern Time on April 25, 2023.

A live webcast of the call will be available on the Investors section of Morphic’s website, at www.morphictx.com. An archived replay will be available on the company’s website following the conference call.

To join the question and answer queue on the live conference call, please click here to register and receive a personalized dial in number.

About MORF-057

Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin for patients with inflammatory bowel disease (IBD). α4β7 has been clinically validated as a target for the treatment of IBD by the success of the approved injectable antibody therapeutic vedolizumab. MORF-057, like vedolizumab, is designed to block the interactions between α4β7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1, substantially reducing lymphocyte migration from the bloodstream into intestinal mucosal tissues and avoiding inflammation that is associated with IBD.

About the EMERALD-1 Study

EMERALD-1 (MORF-057-201) is an open-label multi-center Phase 2a trial designed to evaluate the efficacy, safety, and tolerability of MORF-057 in adults with moderate to severe ulcerative colitis. The 35 patients enrolled in the main cohort of the EMERALD-1 study have been treated with 100 mg BID (twice daily) at sites in the United States and Poland. The primary endpoint of the trial was the change in Robarts Histopathology Index (RHI), a validated instrument that measures histological disease activity in ulcerative colitis at 12 weeks compared to baseline. Patients will continue for an additional 40 weeks of maintenance therapy followed by a 52-week assessment. Secondary and additional pre-specified measures in the EMERALD-1 study include change in the modified Mayo clinic score, safety, pharmacokinetic parameters and key pharmacodynamic measures including α4β7 receptor occupancy and lymphocyte subset trafficking.

About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a portfolio of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis, and cancer. Morphic is also advancing its pipeline and discovery activities in collaboration with Schrödinger using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Contacts
Morphic Therapeutic
Chris Erdman
chris.erdman@morphictx.com
617.686.1718

FAQ

What is the EMERALD-1 Phase 2a study about?

The EMERALD-1 study evaluates the efficacy, safety, and tolerability of MORF-057 in adults with moderate to severe ulcerative colitis.

When will the topline results for MORF-057 be announced?

Topline results will be discussed during a conference call on April 25, 2023.

What was the primary endpoint of the EMERALD-1 study?

The primary endpoint was the change in the Robarts Histopathology Index (RHI) after 12 weeks compared to baseline.

How many patients were enrolled in the EMERALD-1 study?

A total of 35 patients were enrolled in the main cohort of the EMERALD-1 study.

What does MORF-057 target?

MORF-057 selectively inhibits the α4β7 integrin, which plays a role in inflammatory bowel disease.