Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company
developing a new generation of oral integrin therapies for the
treatment of serious chronic diseases, today announced the
publication of an abstract discussing new EMERALD-1 phase 2a
primary results. The data is included in an abstract for a
moderated poster presentation that will be presented by Bruce
Sands, M.D., M.S., at United European Gastroenterology Week (UEGW)
2023 in Copenhagen, Denmark.
The data to be presented provide Morphic with
conviction in the profile of MORF-057 as it advances towards our
goal of providing a safe and effective oral α4β7 inhibitor
treatment option in pill form for inflammatory bowel disease.
Abstract data and new results from the
EMERALD-1 Study of MORF-057 in ulcerative colitis
In EMERALD-1 an open-label, single-arm Phase 2a
trial of MORF-057 that enrolled 35 patients with moderate to severe
UC, MORF-057 achieved the primary endpoint and demonstrated
clinically meaningful improvements across secondary and exploratory
measures. The mean Robarts Histopathology Index (RHI) score from
baseline to week 12 was -6.4 (p=0.0019). Patients also demonstrated
a reduction in modified Mayo Clinic Score (mMCS) from baseline to
week 12 of -2.3 and 25.7% of patients achieved mMCS clinical
remission.
The proportion of patients achieving a mMCS
clinical response was 45.7% and endoscopic improvement was achieved
in 25.7% of patients at week 12 in EMERALD-1. In the context of
α4β7 inhibitors studied in ulcerative colitis, endoscopic
improvement at a much longer timepoint, 52 weeks, was observed in
39.7% of patients receiving vedolizumab in the VARSITY trial, a
double-blind, double dummy trial, which enrolled a patient
population with less severe and less refractory disease. However
comparing the results from different trials may be unreliable due
to different protocol designs, trial designs, patient selection and
populations, number of patients, trial endpoints, trial objectives
and other parameters that may not be the same between trials.
Therefore, cross-study comparisons provide very limited information
about the efficacy or safety of a drug. Results of a head-to-head
comparison may differ significantly from different trial
comparisons.
Pharmacokinetic (PK)/Pharmacodynamic (PD)
evaluations confirmed results seen in healthy volunteer studies,
showing trough drug concentrations leading to a median α4β7
receptor occupancy (RO) >99%. This level of saturation was
achieved early and sustained at week 12.
MORF-057 was well tolerated in EMERALD-1 with no
safety signals observed. There were no serious treatment related
adverse events (TEAEs) and the only two grade 3 TEAEs were
exacerbation of UC, which is consistent with the disease. The most
common TEAEs were UC exacerbation (11.4%) and anemia (8.6%). Anemia
occurs in a third of IBD patients and all anemia occurred in
EMERALD-1 in patients who had anemia at baseline, and they
continued on study with iron supplements.
Moderated Poster Presentation
Information
Clinical proof of principle and favorable
tolerability profile shown with orally dosed MORF-057 as induction
therapy for moderately to severely active UC: Phase 2a from
EMERALD-1 study results
Presenter: Bruce Sands, M.D., M.S., the Dr.
Burrill B. Crohn Professor of Medicine at the Icahn School of
Medicine at Mount Sinai, and Chief of the Dr. Henry Janowitz
Division of Gastroenterology at Mount Sinai Health System
Authors: Bruce Sands, Stefan Schreiber, Silvio
Danese, Jaroslaw Kierkus, Brihad Abhyankar, Michael Choi, Carolyn
Soo, Yujun Wu, Fangui Sun, Dooyoung Lee, Dan Cui, Cuyue Tang, Maloy
Mangada, Ali Hussain, Peter Linde, Adrian Ray, Oladele Babalola,
Sharon Brown, Sarah Hammer, Kerry McConie, Bruce Rogers, Laurent
Peyrin-Biroulet, Brian Feagan
About MORF-057Morphic 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
StudyEMERALD-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 the EMERALD-2
StudyEMERALD-2 (MORF-057-202) is a global phase 2b
randomized, double-blind, placebo-controlled trial of MORF-057 that
is currently enrolling patients with moderate-to-severe ulcerative
colitis. The primary endpoint of EMERALD-2 is clinical remission
rate as measured by the Modified Mayo Clinic Score (mMCS) at 12
weeks. EMERALD-2 will also measure several secondary and
exploratory endpoints based on the mMCS as well as histologic,
pharmacokinetic and pharmacodynamic measures, and safety
parameters. Patients in the EMERALD-2 study will be randomized to
receive either 200 mg BID MORF-057, 100 mg BID MORF-057, a QD (once
daily) dose of MORF-057, or a placebo dose. Following the 12-week
induction phase, all patients will receive MORF-057 for 40 weeks of
maintenance dosing. For more information about the EMERALD clinical
trials of MORF-057, please click here.
About Morphic
TherapeuticMorphic 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.
Cautionary Note Regarding
Forward-Looking StatementsThis press release contains
“forward-looking” statements within the meaning of the Securities
Act of 1933, as amended, the Securities Exchange Act of 1934, as
amended, and of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to: the MInT technology platform’s ability to discover drug
candidates; Morphic’s plans to develop and commercialize oral
small-molecule integrin therapeutics and any proposed timing
thereof; the execution, timing and completion of the EMERALD-1 and
EMERALD-2 clinical trials; any expectations about safety, efficacy,
timing and ability to commence or complete clinical studies and/or
trials and to obtain regulatory approvals for MORF-057, MORF-088
and other candidates in development; the timing of further data
presentation; the ability of MORF-057 to treat IBD, including
ulcerative colitis, or related indications; the ability of αvβ8
small molecule inhibitors, including MORF-088, to treat
myelofibrosis; the ability for additional integrin targets to treat
pulmonary hypertensive diseases; the company’s cash position and
anticipated runway. Statements including words such as “believe,”
“plan,” “continue,” “expect,” “will be,” “develop,” “signal,”
“potential,” “anticipate” or “ongoing” and statements in the future
tense are forward-looking statements. These forward-looking
statements involve risks and uncertainties, as well as assumptions,
which, if they do not fully materialize or prove incorrect, could
cause our results to differ materially from those expressed or
implied by such forward-looking statements. Forward-looking
statements are subject to risks and uncertainties that may cause
Morphic’s actual activities or results to differ significantly from
those expressed in any forward-looking statement, including risks
and uncertainties disclosed in this press release and other risks
set forth in our filings with the Securities and Exchange
Commission, including Morphic’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2022 filed with the SEC on February
23, 2023 and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2023 filed with the SEC on August 23, 2023. These
forward-looking statements speak only as of the date hereof and
Morphic specifically disclaims any obligation to update these
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
ContactsMorphic
TherapeuticChris Erdmanchris.erdman@morphictx.com617.686.1718
Morphic (NASDAQ:MORF)
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