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 initial positive topline data for the first two
cohorts of patients with type 2 diabetes mellitus (T2DM) enrolled
in the Phase II portion of its ongoing Phase I/II clinical study
(COVALENT-111) of BMF-219, the company’s novel, investigational
covalent menin inhibitor.
Beta cell loss has been observed to be a critical component of
the etiology and pathogenesis of both type 2 and type 1 diabetes;
menin is thought to be a key inhibitory regulator that limits beta
cell recovery in the pancreas. Using its proprietary FUSION™
System, Biomea designed BMF-219 to specifically inhibit menin to
release the brakes on beta cells, and potentially enable their
regeneration, reactivation, and preservation. This is the first
clinical observation of patients with diabetes having a robust
glucose-lowering response driven by an investigational menin
inhibitor with a potentially disease-modifying mechanism of action,
which may allow for continued glycemic control for prolonged
periods even after treatment is stopped.
“Our goal with BMF-219 is to deliver the first disease-modifying
treatment for patients with diabetes by addressing the root
biological cause of the disease and its inevitable progression: the
loss of insulin-producing beta cells. Today, we are seeing
indications that we are achieving that goal and that BMF-219 may
indeed be capable of regenerating, preserving, and reactivating
healthy, functional beta cells. Moreover, we are seeing this impact
and high level of glycemic control after just 4 weeks of treatment,
a remarkably short timeframe, and at the first dose level, with
highly favorable safety and tolerability,” said Thomas Butler,
Biomea Fusion’s Chief Executive Officer and Chairman of the Board.
“More than 50% of the 27 million patients in the US diagnosed with
type 2 diabetes have an A1c higher than 7%, indicating that their
current treatments are not able to control their disease and their
increased sugar levels may lead to harming their organs. With
BMF-219, we believe we have the potential to radically transform
the treatment of type 2 diabetes and help millions of patients –
and these initial data certainly support that belief and
excitement.”
Mr. Butler continued, “We are now exploring the various dose
levels in the escalation portion of the study and will select the
two most promising dose levels, to investigate the treatment length
and with the goal of optimizing treatment responses and durability
for the majority of diabetes patients. Importantly, these initial
data also give us the confidence to continue our plans to move
forward with evaluating BMF-219 as a potential treatment for
patients with type 1 diabetes. This is an exciting day for the
Biomea team, but most importantly an exciting day for patients with
diabetes.”
Dr Jose E. Rodriguez, Internal Medicine & Medical Director
at the Southwest General Healthcare Center (Fort Myers, Florida), a
treating physician in COVALENT-111, added, “my patients had great
benefits being included in COVALENT-111. The study drug showed
hardly any side effects and was easily accepted. My patients are
seeing positive health improvements, and I can literally say they
are generally feeling better, overall happy and are enthusiastic,
with more energy than they had before they started the study.”
Preliminary Clinical Data
40 patients were enrolled in the first three cohorts of
COVALENT-111, with the first cohort (Cohort 1) comprising 16
healthy volunteers (HVs); 12 HVs were exposed to 100 mg BMF-219
once daily (QD) for two weeks and 4 HVs were exposed to placebo. In
Cohorts 2 and 3, T2DM patients (n=12 per cohort with 10 patients
treated with BMF-219 and 2 patients on placebo) received BMF-219
once daily for 4 weeks with or without food, respectively. In the
two active treatment cohorts, enrolled patients had T2DM diagnosed
for <15 years, were between the ages of 18 to 65, had been
treated with lifestyle management together with up to three
anti-diabetic medications, with a stable dose 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 enrolled in the two active treatment cohorts,
Cohorts 2 and 3, had a median A1c of 7.9 and 7.8%,
respectively.
A negative food effect was seen between active treatment Cohort
3 (BMF-219 dosing without food) and Cohort 2 (BMF-219 dosing with
food), which decreased the exposure significantly. Patients in
active treatment Cohort 3 (taken without food) saw about a
three-fold median increase in Cmax (ng/ml) and AUC (ng x h/ml)
compared to Cohort 2 (taken with food).
Additional Clinical Observations:
- Cohort 3: Patients on BMF-219
demonstrated a median A1c reduction: -1.0% and an 89% response rate
at 4 weeks
- 78% of patients achieved a >0.5%
reduction in A1c
- 56% achieved a >1.0% reduction in
A1c
- Cohort 2: Patients on BMF-219 had a
median A1c reduction: -0.3% and a 70% response rate at 4 weeks
- 30% of patients achieved a >0.5%
to <1.0% reduction in A1c
- Placebo: 4 diabetic patients on
placebo had a median A1c and mean A1c reduction between -0.1% to
-0.15%
In COVALENT-111 all patients are being assessed for changes in
plasma glucose, HOMA-B, HOMA-IR, C-peptide, fasting insulin, oral
glucose tolerance testing, key metabolic and lipid parameters,
including weight, triglycerides, cholesterol, and for durability of
response after BMF-219 treatment has completed. Further analysis
and a detailed data summary will be presented at an upcoming major
medical meeting.
Initial Tolerability Data
BMF-219 was generally well tolerated; all patients completed the
4-week treatment, and all patients continue in follow-up to assess
the durability of the treatment effect. There were no dose
reductions, serious adverse events, or severe adverse events. In
the active treatment Cohorts 2 and 3 (100 mg QD, n=24) 7 of 20
patients treated with BMF-219 showed mild (Grade 1) Treatment
Emergent AEs (TEAEs), 1 of 20 patients treated with BMF-219 showed
a moderate (Grade 2) TEAE and 2 of 4 patients treated with placebo
showed mild (Grade 1) TEAEs. No patients showed symptomatic
hypoglycemia and no other TEAEs were observed.
In the healthy volunteer Cohort 1 (100 mg QD, n=16), 2 of 12
subjects treated with BMF-219 and 1 of 4 subjects treated with
placebo showed mild (Grade 1) TEAEs. No other TEAEs were
observed.
Conference Call and Webcast Details
Webcast, and related presentation, of Biomea’s investor update
on Tuesday, March 28th at 8:30 am ET will be available to
registered attendees under the Investors and Media section of the
company’s website at
https://investors.biomeafusion.com/news-events/events. A replay of
the presentation will be archived on Biomea’s website following the
event.
Participants who want to join the call and ask a question may
register here to receive the dial-in numbers and unique PIN to
seamlessly access the call. Otherwise please access the listen-only
webcast available at
https://investors.biomeafusion.com/news-events/events.
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 subjects were enrolled in single
ascending dose cohorts to ensure safety at the prospective dosing
levels for type 2 diabetic patients. Phase II consists of multiple
ascending dose 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 our
cash runway, the clinical and therapeutic potential of our product
candidates and development programs, including BMF-219, the
potential of BMF-219 as a treatment for various types of cancer and
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, that initial results may not be indicative of final results
in later clinical trials, the availability of future data from the
Phase II portion of the study, 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 we may
encounter delays or unforeseen results in preclinical development,
IND-filing and acceptance, patient enrollment and in the
initiation, conduct and completion of our 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.
Contact:Sasha BlaugSVP Corporate
Developmentsb@biomeafusion.com
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