Abcuro Completes Enrollment of Registrational Phase 2/3 MUSCLE Clinical Trial of Ulviprubart for the Treatment of Inclusion Body Myositis
June 25 2024 - 7:00AM
Business Wire
Abcuro, Inc., a clinical-stage biotechnology company developing
therapies for the treatment of autoimmune diseases and cancer
through precise modulation of cytotoxic T cells, today announced
the completion of enrollment of the registrational Phase 2/3 MUSCLE
clinical trial evaluating ulviprubart (ABC008) for the treatment of
inclusion body myositis (IBM).
“We continue to focus on advancing our product candidate
ulviprubart to treat patients with IBM who currently have no
treatment options and are therefore delighted to achieve another
important milestone for this clinical program,” said H. Jeffery
Wilkins, M.D., Chief Medical Officer of Abcuro. “Ulviprubart is a
first-in-class therapy targeting KLRG1 and has great potential to
transform the treatment paradigm for IBM where there is currently a
significant unmet need. We look forward to sharing initial data
from the Phase 2/3 MUSCLE trial in the first half of 2026.”
"IBM is a tremendously debilitating disease which drastically
and irreversibly reduces quality of life. Families are deeply
affected as they witness their loved one's decline, while
troubleshooting each facet of daily life to accommodate the
condition. Living with IBM can make basic daily activities
difficult and can negatively impact larger goals like maintaining
hobbies and travel,” said Paula J. Eichenbrenner, MBA, CAE,
Executive Director of The Myositis Association. "IBM patients have
no recourse in the current therapeutic landscape. Exercise and
physical therapy can preserve muscle and stave off disease
progression, but only to a degree. The lack of disease-modifying
treatment options places more burden on IBM families as they must
help their loved ones to manage anxiety about the inevitable muscle
loss they will endure and feelings of being trapped with this rare,
catastrophic disease."
The Phase 2/3 MUSCLE clinical trial (NCT05721573) is a global,
randomized, double-blind, placebo-controlled, parallel multicenter
registrational trial evaluating ulviprubart in patients with IBM.
The objectives of the trial are to evaluate efficacy, safety, and
tolerability of two dose levels of ulviprubart (0.5 mg/kg and 2.0
mg/kg) compared with placebo at 76 weeks in subjects with IBM
followed by a 4-week safety follow-up period.
About Ulviprubart
Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody
product candidate capable of selectively depleting highly cytotoxic
T cells, while sparing naïve, regulatory and central memory T
cells. Ulviprubart is designed to treat diseases mediated by highly
cytotoxic T cells, including the autoimmune muscle disease
inclusion body myositis (IBM), T cell large granular lymphocytic
leukemia (T-LGLL), and mature T cell malignancies. The US Food and
Drug Administration (FDA) and the European Medicines Agency (EMA)
have each granted orphan drug designation to ulviprubart for the
treatment of IBM.
About Inclusion Body Myositis (IBM)
IBM is an autoimmune disease in which highly cytotoxic T cells
chronically attack muscle tissue leading to progressive weakness
and limb muscle atrophy. Patients progressively lose muscle
function, including loss of grip, dexterity and mobility. There are
currently no available disease-modifying treatment options for IBM.
Based on published epidemiology literature, it is estimated that
there are more than 50,000 people with IBM across the US and
Europe.
About Abcuro
Abcuro is a clinical stage biotechnology company developing
first-in-class immunotherapies for the treatment of autoimmune
diseases and cancer through precise modulation of highly cytotoxic
T cells. The company’s lead program is ulviprubart (ABC008) and is
currently in clinical trials for inclusion body myositis (IBM) and
T cell large granular lymphocytic leukemia.
For more information, visit us on LinkedIn and at
abcuro.com.
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Matthew DeYoung Investor Relations and Media Argot Partners
abcuro@argotpartners.com