Assembly Biosciences Announces First Patient Dosed with ABI-M201 in Phase 1b Clinical Trial for Mildly to Moderately Active U...
June 27 2019 - 7:05AM
Assembly Biosciences, Inc. (NASDAQ: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV) and diseases associated with the
microbiome, today announced the initiation of dosing in a Phase 1b
clinical trial to evaluate ABI-M201 (M201) in patients with mildly
to moderately active ulcerative colitis (UC).
M201 is Assembly’s first investigational oral live
biotherapeutic product (LBP) to enter into clinical development, as
part of its gastrointestinal (GI) focused collaboration with
Allergan. M201 is comprised of a rationally designed consortium of
commensal bacteria that were selected based on ability to modulate
ulcerative colitis-relevant cellular mechanisms in human cell-based
assays and animal models. M201 is orally administered
utilizing Assembly’s Gemicel® capsule-in-capsule delivery system,
designed for targeted delivery into the GI tract.
“We are excited to be collaborating with Assembly on these
programs and are pleased to have the Phase 1b trial of M201 now
underway in patients with ulcerative colitis,” said David
Nicholson, EVP and Chief R&D Officer of Allergan. “We believe
Assembly’s strategy for developing innovative, oral,
gastrointestinal therapies manufactured to rigorous quality
standards that utilize targeted GI delivery is differentiated from
other approaches in the microbiome field and offers significant
potential for patients.”
The Phase 1b clinical trial is double-blind, placebo-controlled
and designed to evaluate the safety and efficacy of M201
administered once daily for eight weeks, in approximately 44
patients with mildly to moderately active UC. Study participants
will be enrolled into two sequential non-overlapping cohorts, to
evaluate up to two active dose levels. While the primary objective
of the study is to assess the safety and tolerability of M201, key
efficacy measurements will include clinical remission and
endoscopic improvement.
“We are very pleased with our rapid progress towards clinical
evaluation of M201 and excited to explore the potential of this
oral live microbial biotherapeutic because, despite the
availability of treatments, there remains a significant need to
improve outcomes for patients with ulcerative colitis,” stated
Jackie Papkoff, Ph.D., Assembly’s SVP, Chief Scientific Officer
Microbiome. “Assembly has a strong platform combining scientific
rigor, reproducible and scalable GMP manufacturing processes along
with a novel drug delivery system all of which enable discovery and
rapid advancement of next-generation oral live microbial
biotherapeutics for many diseases based on the human
microbiome.”
About Assembly’s Microbiome PlatformFrom
concept to clinic, Assembly has developed an integrated live
biotherapeutic product (LBP) program from discovery through
manufacturing and ultimately into the clinic that features an
in-house bacterial strain inventory, creating a broad-based
platform that is capable of addressing multiple therapeutic
indications. Individual bacteria and consortia are selected for
development based on a platform of in silico, in vitro and in vivo
capabilities. The biologic drug candidates are manufactured
under scalable GMP conditions. Assembly’s in-house, end-to-end
capabilities also include its licensed patented Gemicel®
capsule-in-capsule delivery system designed for targeted dual
release oral delivery to the gastrointestinal tract (GI).
In January 2017, Assembly entered into a Research Development
Collaboration and License Agreement with Allergan with potential
development and commercial milestones of up to $2.8 billion to
jointly develop LBP compounds for Ulcerative colitis (UC), Crohn’s
Disease and Irritable Bowel Syndromes. ABI-M201, the first LBP
candidate under this collaboration, is being evaluated in a Phase
1b clinical trial in patients with mildly to moderately active UC.
Assembly’s discovery and development capabilities and manufacturing
expertise also are being leveraged to advance new proprietary
candidates for other disease indications.
About Assembly BiosciencesAssembly
Biosciences, Inc. is a clinical-stage biotechnology company
developing innovative therapeutics targeting hepatitis B virus
(HBV) and diseases associated with the microbiome. The HBV program
is focused on advancing a new class of potent, oral core inhibitors
that have the potential to increase cure rates for chronically
infected patients. The microbiome program is developing novel
oral live microbial biotherapeutic candidates with Assembly’s fully
integrated platform, including a robust process for strain
identification and selection, GMP banking and production, and
targeted delivery to the lower gastrointestinal tract with the
GEMICEL® technology. For more information,
visit assemblybio.com.
Forward-Looking Statements The information in
this press release contains forward-looking statements regarding
future events, including statements about the clinical and
therapeutic potential of oral live biotherapeutic product,
including ABI-M201 and the potential milestone payments under the
Allergan collaboration agreement . Certain forward-looking
statements may be identified by reference to a future period or by
use of forward-looking terminology such as “expected,” “may,”
“projected” and “potential.” Assembly intends such forward-looking
statements to be covered by the safe harbor provisions contained in
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. Actual
results or developments may differ materially from those projected
or implied in these forward-looking statements. More information
about the risks and uncertainties faced by Assembly are more fully
detailed under the heading “Risk Factors” in Assembly's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2019 filed with
the Securities and Exchange Commission. Except as required by law,
Assembly assumes no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts Assembly Biosciences, Inc. Investors:
Lauren Glaser (415) 521-3828 lglaser@assemblybio.com
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