Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech
company with a differentiated, small-molecule approach to treating
inflammatory conditions and diseases by selectively targeting the
resident microbiome to restore gut-immune homeostasis, today
announced topline data from the non-IND/CTA clinical study
evaluating KB295, a novel Microbiome Metabolic Therapy (MMT™), in
mild-to-moderate ulcerative colitis (UC). The primary objective of
safety and tolerability was achieved as KB295 was well tolerated
and no safety concerns were observed. In the study, subjects
receiving KB295 experienced a reduction in three biomarkers, fecal
calprotectin (FCP), fecal lactoferrin, and FimH that are known to
be associated with UC disease activity. These results are
complemented by preclinical studies conducted with Kaleido’s unique
translational ex vivo platform using human donor-derived microbiome
communities.
Highlights from the Topline KB295 Dataset for
Mild-to-Moderate in UC
Clinical Data Observed at the End of an Eight-Week Intake
Period
- Achieved primary objective of safety and tolerability with
KB295 being well tolerated across subjects (n=12) with no
product-emergent serious adverse events reported
- Observed a meaningful reduction in three key biomarkers: FCP,
fecal lactoferrin, and FimH, known to be strongly correlated with
inflammation and disease activity:
- Median FCP levels decreased by 69% in subjects with evaluable
FCP (n=11), and 74% in subjects identified as responders (8 of 11);
responders were defined as those subjects with FCP reduction
greater than 50%
- Fecal lactoferrin decreased by a median of 69% in subjects with
currently available samples (n=6), including five out of six
subjects with a reduction of at least 50%
- FimH decreased by a median of 93% in subjects evaluated with
currently available samples (n=5)
- Further fecal lactoferrin and FimH analysis is expected as
additional subject samples become available
Pre-Clinical Data from Ex-Vivo Studies
- Ex-vivo data demonstrated community-wide changes and desired
modulation of multiple remission-associated taxa
- Total short chain fatty acid (SCFA) production increased in
ex-vivo studies to levels that are pharmacologically relevant to
UC
Anticipated Milestones
- Observations from both preclinical and clinical data support
the Company’s plans to initiate a phase 2 study, under an
Investigational New Drug (IND) application and Clinical Trial
Application (CTA), with KB295 for mild-to-moderate UC patients in
the first half of 2022
- Manufacturing and toxicity work has commenced to support future
studies under CTA and IND applications
“The data we shared today highlight the potential of our MMT
platform and its ability to work with a person’s microbiome as
opposed to replacing it,” said Dan Menichella, President and Chief
Executive Officer of Kaleido. “Ulcerative colitis is largely driven
by gut microbiome dysbiosis, and KB295 modulates microbiome
composition and metabolic output, thereby driving immune activity
both locally and systemically to restore gut immune homeostasis in
those with UC. We are excited about the data package and look
forward to advancing KB295 in a phase 2 ulcerative colitis study
under an IND.”
KB295 was evaluated in an exploratory, open-label, single arm
non-IND clinical study in subjects with mild-to-moderate UC.
Subjects received KB295 for eight weeks, titrated up to 40g twice
daily and then entered a two-week follow-up period. The study was
designed to evaluate the safety and tolerability of KB295 with
other exploratory assessments including changes in microbiome
composition, SCFA levels in stool and biomarkers of inflammation
(fecal calprotectin and lactoferrin and FimH). The trial was
originally designed to enroll 30 subjects at a single site in
Ireland, however, due to COVID-19 related enrollment impacts, 12
subjects were enrolled, primarily from Ireland. Primary
pharmacology data were generated with Kaleido’s unique
translational ex vivo platform using human donor-derived microbiome
communities as well as microbiome and biomarker read-outs on the
currently available samples from the first six subjects that
entered the study.
UC is an inflammatory bowel disease that can cause debilitating
symptoms, including abdominal pain, bowel urgency and diarrhea.
Evidence shows that a feature of UC is alteration of the gut
microbiome, including an increase in inflammatory bacteria and
decrease in commensal microbe diversity and short chain fatty
acids, which interfere with the normal immune response. Major
scientific advances have demonstrated that the microbiome is a
legitimate intervention target in the management of this
disease.
Conference Call and Webcast InformationKaleido
management will host a conference call with accompanying slides
today at 8:00 a.m. ET. Analysts and investors are invited to
participate in the conference call by dialing (833) 423-0448 from
the U.S. and Canada or (956) 394-3566
internationally and using the conference ID 5754389. The live
webcast can be accessed on the investor page of Kaleido’s website
at investors.kaleido.com. A replay of the webcast will be
available on Kaleido’s website approximately two hours after the
completion of the event and will be archived for at least 30
days.
The agenda will feature an update on the Company’s corporate
strategy, data from the non-IND study evaluating KB295 in
mild-to-moderate UC as well as supportive preclinical data, and
data supporting the advancement of KB109 into COPD. The program
will also feature presentations by Bruce Sands, M.D., Dr. Burrill
B. Crohn Professor of Medicine at the Icahn School of Medicine at
Mount Sinai and Ruth Tal-Singer, Ph.D., President and Chief
Scientific Officer of the COPD Foundation.
About Ulcerative ColitisUlcerative colitis
(“UC”) is a chronic disease of the large intestine, in which the
lining of the colon becomes inflamed and develops tiny open sores,
or ulcers. Those ulcers produce pus and mucus, cause abdominal pain
and result in the need to frequently empty the colon. Although UC
is the result of several factors that are not yet well understood,
abnormal immune response, genetics, microbiome, and environmental
factors all contribute to the disease. UC can occur at any age,
though most people are diagnosed prior to their mid-30s. In the
United States, approximately one million people are affected with
UC, and reported symptoms include loose stool and urgent bowel
movements, bloody stool, abdominal cramps and pain, and persistent
diarrhea accompanied by abdominal pain and blood in the stool.
There is no known curative treatment for UC. Treatment is
multifaceted and includes the use of medication, alterations in
diet and nutrition, and sometimes surgical procedures to repair or
remove affected portions of a patient’s gastrointestinal tract.
Several types of medication can be used to suppress UC symptoms
(induce remission) and decrease the frequency of symptom flares
(maintain remission) including anti-inflammatory drugs,
immunosuppressants, and biologics. UC is often a progressive
disease meaning that over time patients respond less to a specific
medication and need to progress to other treatments. Current
therapies, such as anti-inflammatory drugs, immunosuppressants, and
biologics can also be associated with significant side effects.
There is a clinical need for new therapeutic options with durable
efficacy and an improved safety profile.
About Microbiome Metabolic Therapies (MMT™)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to
drive the function and distribution of the microbiome’s existing
microbes in order to decrease or increase the production of
metabolites, or to advantage or disadvantage certain bacteria in
the microbiome community. The Company’s initial MMT candidates are
targeted, synthetic glycans that are orally administered, have
limited systemic exposure, and are selectively metabolized by
enzymes in the microbiome. Kaleido utilizes its discovery and
development platform to study MMTs in microbiome samples to rapidly
advance MMT candidates into clinical studies in healthy subjects
and patients. These human clinical studies may be conducted under
regulations supporting research with food, evaluating safety and
tolerability and impact on the microbiome. For MMT candidates that
are developed as therapeutics, the Company currently conducts and
will conduct clinical trials under an Investigational New Drug
(IND) or regulatory equivalent outside the U.S., often in Phase 2
or later development.
About Kaleido BiosciencesKaleido
Biosciences is a clinical-stage biotech company with a
differentiated, small-molecule approach to treating inflammatory
conditions and diseases by selectively targeting the resident
microbiome to restore gut-immune homeostasis. The Company has built
a proprietary product platform to enable the rapid and
cost-efficient discovery and development of novel Microbiome
Metabolic Therapies (MMT™). MMTs are designed to modulate the
metabolic output and profile of the microbiome by driving the
function and distribution of the gut’s existing microbes. Kaleido
is advancing a broad pipeline of MMT candidates with the potential
to address a variety of diseases and conditions with significant
unmet patient needs. To learn more,
visit https://kaleido.com/.
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, statements regarding clinical study
plans and timelines, regulatory plans, and the Company’s business
focus. The words “may,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, those related to the breadth of our pipeline of product
candidates, the strength of our proprietary product platform, the
efficiency of our discovery and development approach, the clinical
development and safety profile of our MMT candidates and their
therapeutic potential, whether and when, if at all, regulatory
agencies will approve our IND application or clinical trial
applications for KB295 or KB109, whether and when, if at all, our
MMT candidates will receive approval from the U.S. Food and Drug
Administration or other regulatory agencies and for which, if any,
indications, competition from other biotechnology companies, and
other risks identified in our SEC filings, including our most
recent Form 10-K, and subsequent filings with the SEC. We caution
you not to place undue reliance on any forward-looking statements,
which speak only as of the date they are made. We disclaim any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements.
Contacts:
Kaleido BiosciencesWilliam Duke, Jr.Chief
Financial Officer617-890-5772william.duke@kaleido.com
Investors and MediaKotaro YoshidaArgot
Partners212-600-1902kaleido@argotpartners.com
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