Exhibit
99.1
Lipocine
Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity
| |
● |
LPCN
2401 treatment resulted in statistically significant body composition improvement in men |
| |
● |
Increased
lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% |
| |
● |
Reduced
android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% |
| |
● |
Well-tolerated,
adverse events (AEs) similar to placebo |
| |
● |
Potential
for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy post
discontinuation |
| |
● |
Conference
call and webcast at 8.30 a.m. ET today |
SALT
LAKE CITY, April 11, 2024 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced results from
a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist
and α-tocopherol, an antioxidant. The results showed significant improvement in body composition through decreased FM and increased
LM or fat free mass (FFM) in patients with BMI ≥ 30 (obese) or BMI ≥ 27 with at least one weight-related comorbidity.
“We
are pleased with these results demonstrating that LPCN 2401 improves body composition by gaining lean mass and reducing fat mass,”
said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “As an adjunct therapy to GLP-1/GIP agonists, we believe LPCN 2401 may
improve muscle mass, quality, and functionality while maintaining weight loss and amplifying fat loss. Furthermore LPCN 2401 could help
to attenuate collateral fattening and rebound fat/weight “overshoot” associated with discontinuation of GLP-1/GIP agonists.
We look forward to meeting with the FDA to discuss the further development of LPCN 2401 as an aid to weight management interventions.”
This
multi-center prospective, blinded Phase 2 study included participants with obesity (BMI ≥30) and participants with BMI ≥27 with
at least one weight-related comorbidity (e.g. hypertension, type 2 diabetes, dyslipidemia), a population consistent with FDA guidance
for developing products for weight management. Participants were randomized to receive one of three treatments for 36 weeks: A) testosterone
ester monotherapy capsule, B) T ester + α-tocopherol capsule (LPCN 2401), or C) matching placebo. Participants underwent Dual-Energy
X-Ray Absorptiometry (DEXA) scans to measure body composition at baseline and Weeks 20 and 36. Safety and tolerability were monitored
throughout the 36 weeks. Analyses of body composition parameters, including prespecified endpoints of whole body LM and whole-body FM,
are reported in the table below.
Results
Among
treatments B and C, 27 participants were randomized and completed the baseline and at least one post-baseline DEXA. At baseline, mean
BMI was 36.0 kg/m2 and mean age was 52.4 yrs. LPCN 2401 intervention resulted in significant FM lost and LM gained compared
to placebo; a significant improvement was noted as early as Week 20. A significant reduction in AF (fat in the area roughly between the
pelvis and ribs) and a significant increase in BMC were observed in treatment B, the LPCN 2401 intervention arm. The intervention was
observed to be weight neutral, with fat lost offset by lean mass gained. An overall improvement in body composition is evidenced by substantial
decrease in the fat mass to lean mass ratio.
Table:
Mean Changes in Body Composition with LPCN 2401
| |
|
LPCN
2401 N= 13 |
|
Placebo
N = 14 |
|
LPCN
2401-Placebo
|
| |
|
Baseline |
|
Week
36
Relative
CBL |
|
Baseline |
|
Week
36
Relative
CBL |
|
adjusted
difference
(P
value) |
| Fat
Mass* |
|
37.2 |
|
-5.6
|
|
39.3 |
|
1.1 |
|
-6.7
(0.02) |
| Lean
Mass* |
|
62.8 |
|
3.9 |
|
60.7 |
|
-0.5 |
|
4.4
(0.02) |
| Android
** |
|
11.9 |
|
-3.5 |
|
11.2 |
|
0.7 |
|
-4.1
(0.04) |
| BMC
(kg) |
|
3.1 |
|
1.3 |
|
3.0 |
|
-1.6 |
|
2.8
(0.01) |
| FM
: LM Ratio |
|
0.60 |
|
-8.6 |
|
0.66 |
|
2.0 |
|
-10.6
(0.02) |
*
% of total mass; ** % of fat mass; BMC = bone mineral content; FM = fat mass; LM = lean mass, CBL = change from baseline
Analyses
set includes all randomized participants (ITT) who have baseline DEXA data and at least one post-baseline DEXA scan. Data are arithmetic
means, last observation carried forward (LOCF).
LPCN
2401 resulted in numerically greater fat mass loss than Treatment A (monotherapy). Numerical trends towards improvement in blood pressure
and HbA1c with LPCN 2401 support the benefit of Treatment B relative to both placebo and Treatment A. LPCN 2401 was well-tolerated with
the frequency and severity of observed treatment-emergent AEs comparable to placebo. No GI or muscle spasm adverse events were reported
by participants receiving LPCN 2401.
Dr.
Jaime Almandoz, MD, Medical Director of the Weight Wellness Program, and an Associate Professor of Internal Medicine at UT Southwestern
Medical Center, added “Treatment with LPCN 2401 resulted in loss of fat mass and significant gains in lean mass in men with obesity.
Although the reductions in total body weight were modest, this is very exciting as many popular interventions for treating obesity lead
to reductions in lean mass, which can result in negative clinical outcomes.”
Dr.
Frank Greenway, MD, Professor, and Medical Director of the Pennington Biomedical Research Center of the LSU System and recipient of the
Distinguished Leader Award from the American Board of Obesity Medicine in 2018 stated, “The medical risk of obesity is associated
with excess fat tissue. Men with obesity distribute their excess fat primarily in the abdominal area which is associated with a greater
risk of cardiovascular disease. Despite this greater medical risk, men are under-represented in trials of medications to treat obesity.
On the strength of these data, LPCN 2401 has the potential to fill an unmet medical need in men by reducing body fat, increasing lean
mass and increasing bone mass to achieve a healthier composition of the body. As expected, this change in body composition is associated
with healthier blood pressure and healthier blood sugar measurements.”
Recently
approved, incretin mimetics (e.g. semaglutide, Wegovy®, tirzepatide, Zepbound®) are widely used in chronic weight management.
However, the rapid weight loss observed with these medications includes a substantial proportion of lean mass loss, ~25-40% of the patient’s
total weight lost. Lower LM can lead to higher fat rebound (collateral fattening) post cessation of a weight loss intervention. The Week
36 LPCN 2401 results support its potential for improved body composition in chronic weight management with incretin mimetics.
About
Chronic Obesity Management and Unmet Need
Approximately
74% of US adults age 20 and older are either obese or overweight, and an estimated 30% of the US adult population have BMI ≥ 30 kg/m2.
Obesity is a chronic, relapsing health risk defined by excess body fat. Excess body fat increases the risk of death and major comorbidities
such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, osteoarthritis of the knee, sleep apnea, and some cancers
(Caterson and Hubbard et al. 2004; Calle and Thun et al. 1999). Reportedly (Flynn et al. Morgan Stanley, February 27, 2024), ~24M obese
elderly are most vulnerable to losing muscle mass.
The
rapid weight loss observed with the approved weight management medications includes unwanted LM loss, up to 40% of the patient’s
total weight lost. Moreover, discontinuation of these therapies frequently results in a rapid regain in weight. Loss of LM has multiple
negative health implications including weakness/fatigue, lowered metabolism which can cause a regain in fat mass, declines in neuromuscular
function, potential effects on emotion and psychological states, and increased risk of injury.
Several
recent studies showed that body composition, especially lean body mass (muscle) may play an independent role in survival of patients
with diseases such as cancer and cardiovascular diseases (DH Lee and EL Giovannucci, Exp Biol Med. 2018). Therefore, a focus on body
composition in obesity management to sustainably lose FM while maintaining LM should be an essential goal.
There
is a significant unmet need for an oral, efficacious, muscle preserving/gaining option for chronic obesity/weight management that ameliorates
the loss of LM associated with GLP-1/GIP agonist treatment, resulting in a higher quality weight loss. Moreover, there is a need for
a chronic long-term pharmacotherapy option to maintain weight upon cessation of incretin mimetic therapy, prevent fat/weight rebound
“overshoot” and minimize lag in muscle recovery to prevent collateral fattening.
About
LPCN 2401
LPCN
2401 is an oral formulation of a proprietary combination of anabolic androgen receptor agonist and α-alpha tocopherol, an antioxidant
metabolic modifier. Data from preclinical and clinical studies support the potential of LPCN 2401 in gaining lean mass while losing fat
mass. As adjunct therapy to incretin mimetics, LPCN 2401 has potential to attenuate weight rebound, ameliorate loss of muscle mass, improve
muscle quality and functionality, amplify fat mass loss with improved body composition, and potential to maintain weight, prevent “fat
overshoot,” and accelerate muscle rebound post incretin mimetic discontinuation.
Conference
Call and Webcast
Lipocine
management will host a conference call and webcast with slides beginning at 8:30 a.m. Eastern Time today to discuss the Phase 2 clinical
study results and answer questions. To participate via telephone, please dial 1-877-451-6152 or 1-201-389-0879 (ex-U.S. toll dial-in
number) using the conference ID 13745946.
Participants
can also click the Call me™ link, https://viavid.webcasts.com/starthere.jsp?ei=1666049&tp_key=c017f4b96c
for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start
time.
The
webcast is available to view here and also at www.lipocine.com. It will be available for replay for 180 days.
About
Lipocine
Lipocine
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which
we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for
favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.
Lipocine’s
clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101
for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral
proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin
mimetics, as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug
for oral administration targeted for the management of symptoms associated with liver cirrhosis including prevention of the recurrence
of overt hepatic encephalopathy. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm
birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144,
our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed
by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism,
in adult males. For more information, please visit www.lipocine.com.
Forward-Looking
Statements
This
release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and include statements that are not historical facts regarding the development and commercialization of
LPCN 2401 and the potential uses and benefits of LPCN 2401 for the improvement of body composition in obesity management. This release
also contains statements regarding the potential uses and benefits of our other product candidates. Investors are cautioned that all
such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful
in developing product candidates to treat obesity disorders, we may not have sufficient capital to complete the development processes
for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets,
the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and
regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval
process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results
and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s
products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports
on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise
publicly any forward-looking statements contained in this release, except as required by law.
SOURCE
Lipocine Inc.
For
further information:
Krista
Fogarty
Phone:
(801) 994-7383
kf@lipocine.com
Investors:
PJ
Kelleher
Phone:
(617) 430-7579
pkelleher@lifesciadvisors.com
