Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage
biopharmaceutical company dedicated to discovering and developing
novel covalent small molecules to treat and improve the lives of
patients with genetically defined cancers and metabolic diseases,
today announced the poster presentation of long-term 26 weeks
follow-up data from the first two cohorts of adults with type 2
diabetes (T2D) enrolled in the ongoing Phase II clinical study
(COVALENT-111) and data from preclinical ex-vivo human islet
experiments of BMF-219, the company’s investigational oral covalent
menin inhibitor.
“Our goal with BMF-219 is to create a short-term
treatment regimen for patients with diabetes that results in long
term glycemic control. With the preclinical data we have published
at the WCIRDC here in Los Angeles, we believe we have provided
initial proof for menin’s important role in diabetes, as it
controls a highly relevant pathway known to reestablish beta cell
health and function. We believe we have also shown that our
investigational covalent agent, BMF-219, is a very targeted and
effective menin inhibitor that has been generally well tolerated in
our human studies to date. So far, we have only reported on
patients in COVALENT-111 with our first dose of BMF-219 at 100 mg,
at our first dose duration of 4 weeks. These early clinical results
of improved glycemic control over time while patients are off
treatment have been very impressive. Our preclinical data suggests
that we should be able to improve them even further with longer
dosing durations,” said Thomas Butler, Biomea Fusion’s Chief
Executive Officer and Chairman of the Board.
Clinical Update for COVALENT-111 at
WCIRDC 2023
40 patients were enrolled in the first three
Multiple Ascending Dose (MAD) cohorts of COVALENT-111, with the
first cohort (Cohort 1) comprising 16 healthy volunteers (HVs); 12
HVs received 100 mg of BMF-219 once daily (QD) and 4 HVs received
placebo QD for two weeks and thereafter followed off treatment for
an additional six weeks. In Cohorts 2 and 3, T2D patients (n=12 per
cohort with 10 patients treated with 100 mg BMF-219 QD and 2
placebo patients QD) were treated for four weeks with or without
food, respectively, and then followed for 22 weeks after treatment.
In these two treatment cohorts, enrolled patients had T2D diagnosed
within the last 15 years, were between the ages of 18 to 65, had
been treated with lifestyle management with up to three
standard-of-care anti-diabetic medications, excluding sulfonylureas
and insulin, with a stable dosing regimen for at least two months
prior to screening, had a BMI ≥25 and ≤40 kg/m2, and had poorly
controlled diabetes (HbA1c ≥7.0% and ≤10%). At baseline, diabetic
patients in Cohorts 2 and 3 had a mean HbA1c of 8.0% and 8.1%,
respectively.
Efficacy Data
- 26 Week Glycemic
Data:
- At Week 26, 22 weeks after the last
dose of BMF-219, participants in 100 mg BMF-219 QD (without food)
cohort saw an improved placebo adjusted mean reduction in HbA1c of
0.8% [As reported in March 2023 at the end of the 4-week dosing
period, 0.7% placebo adjusted mean reduction in HbA1c was achieved
in 100 mg BMF-219 QD (without food) cohort]; Participants in 100 mg
BMF-219 QD (with food) cohort saw an improved placebo adjusted mean
reduction in HbA1c of 0.2% at Week 26
- 20% of patients from the 100mg dose
cohorts displayed a reduction in HbA1c of 1% or more, compared to
0% of patients for placebo at Week 26
- After only four weeks of dosing and
22 weeks off treatment, participants in BMF-219 100 mg QD without
food cohort demonstrated an 80% response rate – with any reduction
in HbA1c (40% response rate in 100 mg QD with food cohort)
- 26 Week
Pharmacokinetic Data:
- Cohort 3 resulted
in approximately 2.7-fold higher BMF-219 exposure than Cohort
2
- Higher exposure
resulted in greater reduction in HbA1c
- Increase in mean
HOMA-B and AUC C-peptide in Responders at Week 26:
- After 4 weeks of
once daily BMF-219, responders (defined as HbA1c reduction
≥0.5% at Week 26) with baseline HOMA-B <200
(upper limit of normal) across both cohorts, achieved a
greater increase from baseline in placebo-adjusted HOMA-B (+270%)
and stimulated C-peptide AUC (+22%) at Week 26
Safety Data
- Generally
well-tolerated with no severe or serious adverse events
- No symptomatic or
clinically significant hypoglycemia
- No dose
discontinuation or modification
Preclinical Ex-Vivo Human Islet
Data:
- BMF-219 was
observed to upregulate the expression of key cell-cycle proteins,
PbK and CCNA2 (Cyclin A2), in a glucose-dependent fashion. When not
sequestered to menin, PbK expression was known to be upregulated by
JunD, which is a glucose-sensitive menin binding partner.
- Dependent on dose
concentration and also dependent on dose duration, BMF-219 was
observed to increase beta cell mass and function, as well as
promote controlled proliferation and enhance insulin content in
beta cells. Proliferation was observed only under elevated glucose
conditions, which mimics diabetic levels, and with continuous drug
exposure.
Next Steps and Updates with
BMF-219
- BMF-219 in Type 1
and Type 2 Diabetes
- Complete dose
escalation for all dose levels in COVALENT-111
- Initiate dose
expansion portion of COVALENT-111 with longer durations of
treatment (for up to 12 weeks) at two dose levels including 100 mg
and 200 mg
- Explore utility of
BMF-219 in type 1 diabetes and initiate enrollment of COVALENT-112
trial
COVALENT-111
COVALENT-111 is a multi-site, randomized,
double-blind, placebo-controlled Phase I/II study. In the completed
Phase I portion of the trial, healthy patients were enrolled in
single ascending dose (SAD) cohorts to evaluate safety at the
prospective dosing levels for type 2 diabetic patients. Phase II
consists of multiple ascending dose (MAD) cohorts and includes
adult patients with type 2 diabetes uncontrolled by current
therapies. Additional information about the Phase I/II clinical
trial of BMF-219 in type 2 diabetes can be found at
ClinicalTrials.gov using the identifier NCT05731544.
About Menin’s Role in
Diabetes
Loss of functional beta cell mass is a core
component of the natural history in both types of diabetes — type 1
diabetes (mediated by autoimmune dysfunction) and type 2 diabetes
(mediated by metabolic dysfunction). Beta cells are found in the
pancreas and are responsible for the synthesis and secretion of
insulin. Insulin is a hormone that helps the body use glucose for
energy and helps control blood glucose levels. In patients with
diabetes, beta cell mass and function have been observed to be
diminished, leading to insufficient insulin secretion and
hyperglycemia. Menin is thought to act as a brake on beta-cell
turnover and growth, supporting the notion that inhibition of menin
could lead to the regeneration of normal, healthy beta cells. Based
on these and other scientific findings, Biomea is exploring the
potential for BMF-219-mediated menin inhibition as a viable
therapeutic approach to potentially halt or reverse progression of
type 2 diabetes.
About Type 2 Diabetes
Diabetes is considered a chronic health
condition that affects how the body turns food into energy and
results in too much sugar in the bloodstream. Over time, this can
cause serious health problems and damage vital organs. Most people
with diabetes have a shorter life expectancy than people without
this disease. The CDC estimates about 2 in 5 of the adult
population in the USA are now expected to develop diabetes during
their lifetime. More than 37 million people of all ages (about 11%
of the US population) have diabetes today. 96 million adults (more
than 1 in 3) have pre-diabetes, blood sugars that are higher than
normal but not high enough to be classified as diabetes. Diabetes
is also one of the largest economic burdens on the United States
health care system with $1 out of every $4 in US health care costs
being spent on caring for people with diabetes. Despite the current
availability of many diabetes medications, there remains a
significant need in the treatment and care of patients with
diabetes.
About Biomea Fusion
Biomea Fusion is a clinical stage
biopharmaceutical company focused on the discovery and development
of covalent small molecules to treat patients with genetically
defined cancers and metabolic diseases. A covalent small molecule
is a synthetic compound that forms a permanent bond to its target
protein and offers a number of potential advantages over
conventional non-covalent drugs, including greater target
selectivity, lower drug exposure, and the ability to drive a
deeper, more durable response.
We are utilizing our proprietary FUSION™ System
to discover, design and develop a pipeline of next-generation
covalent-binding small molecule medicines designed to maximize
clinical benefit for patients with various cancers and metabolic
diseases, including diabetes. We aim to have an outsized impact on
the treatment of disease for the patients we serve. We aim to
cure.
Visit us at biomeafusion.com and follow us on
LinkedIn, Twitter and Facebook.
Forward-Looking Statements
Statements we make in this press release may
include statements which are not historical facts and are
considered forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). These statements may be identified by
words such as “aims,” “anticipates,” “believes,” “could,”
“estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,”
“plans,” “possible,” “potential,” “seeks,” “will,” and variations
of these words or similar expressions that are intended to identify
forward-looking statements. Any such statements in this press
release that are not statements of historical fact, including
statements regarding the clinical and therapeutic potential of our
product candidates and development programs, including BMF-219, the
potential of BMF-219 as a treatment for type 1 and type 2 diabetes,
our research, development and regulatory plans, including our
pursuit of BMF-219 in metabolic diseases, our plans to continue the
evaluation of BMF-219 for type 2 diabetes in our COVALENT-111
study, the availability of future data from the Phase II portion of
the study, our plans to complete dose escalation, identify optimal
dose levels, initiate dose expansion, explore longer duration of
treatment and additional dosage forms and explore the potential
utility of BMF-219 in type 1 diabetes, and the timing of such
events, may be deemed to be forward-looking statements. We intend
these forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Exchange Act and are
making this statement for purposes of complying with those safe
harbor provisions.
Any forward-looking statements in this press
release are based on our current expectations, estimates and
projections only as of the date of this release and are subject to
a number of risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or
implied by such forward-looking statements, including the risk that
initial results may not be indicative of final results in later
clinical trials, we may encounter delays, regulatory challenges or
unforeseen and/or adverse results in preclinical or clinical
development, we may face difficulties in patient enrollment and in
the initiation, conduct and completion of our ongoing and planned
clinical trials and other research, development and regulatory
activities. These risks concerning Biomea Fusion’s business and
operations are described in additional detail in its periodic
filings with the U.S. Securities and Exchange Commission (the
“SEC”), including its most recent periodic report filed with the
SEC and subsequent filings thereafter. Biomea Fusion explicitly
disclaims any obligation to update any forward-looking statements
except to the extent required by law.
Investor Relations
Chunyi Zhao, PhD
Sr. Manager of Investor Relations & Corporate Development
czhao@biomeafusion.com
Media Relations
Neera Chaudhary, PhD
Chief Commercial Officer – Diabetes
nchaudhary@biomeafusion.com
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