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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of Earliest Event Reported):
July
27, 2023
LIPOCINE
INC.
(Exact
name of registrant as specified in its charter)
Commission
File No. 001-36357
Delaware |
|
99-0370688 |
(State
or other jurisdiction
of
incorporation) |
|
(IRS
Employer
Identification
Number) |
675
Arapeen Drive, Suite
202
Salt
Lake City, Utah
84108
(Address
of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (801)
994-7383
Former
name or former address, if changed since last report: Not Applicable
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §
230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
LPCN |
|
The
NASDAQ Stock Market LLC |
Item
8.01 Other Events
On
July 27, 2023, the Company issued a press release announcing that its LPCN 1148 Phase 2 study met its primary endpoint in patients with
Cirrhosis. The press release is filed as Exhibit 99.1 and is incorporated herein by reference.
Additionally,
the Company will be conducting a webcast/ conference call presenting top-line results from the clinical bridge study results. The Company’s
materials to be used in the presentation are filed hereto as Exhibit 99.2.
Item
9.01 Financial Statements and Exhibits.
The
following exhibits are filed with this report:
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
|
LIPOCINE
INC. |
|
|
|
|
Date: |
July
27, 2023 |
By: |
/s/
Mahesh V. Patel |
|
|
|
Mahesh
V. Patel |
|
|
|
President
and Chief Executive Officer |
Exhibit
99.1
LPCN
1148 Phase 2 Study Meets Primary Endpoint in Patients with Cirrhosis
|
● |
Met
primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01) |
|
|
|
|
● |
Fewer
hepatic encephalopathy (HE) events of grade >1 in the LPCN 1148 treatment arm relative to placebo (P < 0.05) |
|
|
|
|
● |
More
patients on LPCN 1148 reported symptom improvement compared to placebo (P < 0.05) |
|
|
|
|
● |
LPCN
1148 was well-tolerated, with AE rates and severities similar to placebo |
|
|
|
|
● |
Conference
call and webcast today at 8:30am ET |
SALT
LAKE CITY, July 27, 2023 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System
(CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced positive topline results from
a Phase 2 clinical study of LPCN 1148. LPCN 1148 is an oral candidate under development for the clinical management of cirrhosis. Lipocine
plans to meet with the FDA to discuss a development path to NDA filing.
“We
are delighted with the positive results from our Phase 2 study,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “Managing
cirrhosis is a significant unmet medical need with a strong pharmaco-economic rationale. We believe LPCN 1148 is a compelling development
opportunity; if approved, we believe it has potential to be the standard of care in managing advanced cirrhosis.”
This
Phase 2 proof of concept study is an ongoing randomized placebo-controlled study in sarcopenic male patients with cirrhosis on the liver
transplant waitlist. Twenty-nine patients were randomized 1:1 to receive either LPCN 1148 or matching placebo for 24 weeks. At Week 24,
the open-label extension stage of the study begins; during this stage all patients receive LPCN 1148. The study’s primary endpoint
was a change in L3-SMI at week 24. L3-SMI estimates whole body skeletal muscle mass and is the standard for sarcopenia assessment in
cirrhosis. Secondary endpoints included rates of decompensation events including hepatic encephalopathy, and participant-reported change
in symptoms using the PGI-C scale.
All
LPCN 1148-treated patients completed Week 24 (n=15), whereas ten of fourteen placebo patients completed Week 24. All LPCN 1148-treated
patients had at least one evaluable post-baseline CT scan and are therefore part of the modified intent to treat (mITT) analysis; ten
placebo-treated patients had an evaluable post-baseline CT. As prespecified, L3-SMI analysis was performed on the mITT population (n=25),
with the last evaluable post-baseline observation carried forward (LOCF).
Results
Primary
endpoint: LPCN 1148 treatment resulted in a significant increase in L3-SMI at Week 24 compared to placebo, as shown in Table 1 below.
Table
1. Change in L3-SMI at Week 24
|
|
|
|
|
|
P-value |
Timepoint |
|
LPCN
1148
(n=15) |
|
Placebo
(n=10) |
|
Change
from Baseline |
|
Vs.
Placebo |
Baseline
(cm2/m2) |
|
47.8
(1.8) |
|
45.8
(2.3) |
|
N/A |
|
NS |
Week
24 CFB (cm2/m2) |
|
3.62
(0.93) |
|
-
0.74 (1.14) |
|
<0.001 |
|
0.007 |
Data
are LS mean (SE). CFB, Change from Baseline
Clinical
Decompensation Events: 1148-treated patients experienced significantly fewer cases of hepatic encephalopathy > Grade 1 compared
to placebo, despite the two treatment groups having similar number of patients with a medical history of hepatic encephalopathy.
Table
2: Major Decompensation Events During the First 24 Weeks of the Study
|
|
LPCN
1148 (n=15) |
|
Placebo
(n=14) |
Total
decompensation events |
|
7 |
|
10 |
Total
decompensation events > Grade 1 |
|
6 |
|
10 |
Hepatic
Encephalopathy |
|
3 |
|
6 |
HE
> Grade 1 * |
|
2 |
|
6 |
Recurrence
of HE > Grade 1 |
|
1 |
|
6 |
Mean
Time to first recurrence of HE >
Grade
1 (days) |
|
115 |
|
39** |
Decompensation
events include HE, ascites, variceal bleeding, spontaneous bacterial peritonitis
Recurrence
of HE: Medical history of HE + HE events during the study
*P
< 0.05 vs placebo
**
Mean Value
Consistent
with the American Association for the Study
of Liver Disease (AASLD) statement, if a patient recovers a significant amount of liver function and muscle mass from the
time they had bouts of HE, the patient may be able to stop standard HE therapy. Our study results support the concept that
improvement in sarcopenia improves clinical outcomes.
As
assessed by PGI-C, patients who received active treatment reported significant improvement in symptoms as early as Week 4, which persisted
through Week 24. LPCN 1148 patients showed a significant increase in hemoglobin and trended towards resolution of anemia, improvement
of ascites, and reduced total number of days hospitalized. CT scans also suggest improved muscle quality and reduced visceral and subcutaneous
fat with LPCN 1148 therapy.
LPCN
1148 was well-tolerated, with adverse event (AE) rates and severities similar to placebo; no mortality was noted in the LPCN 1148 treatment
group. Rates of diarrhea and nausea were low and similar in both groups. There were no cases of drug-induced liver injury.
Dr.
Arun J. Sanyal, MD, Interim Chair, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, commented,
“Sarcopenia and frailty are major markers of poor outcomes for patients with end-stage liver disease. It is very exciting to see
proof of concept that correction of sarcopenia by LPCN 1148 safely improved muscle mass, functional status and quality of life as well
as reduced days in the hospital compared to placebo. This demonstrates for the first time that correcting sarcopenia improves many clinically
significant issues for this very sick population and could provide a better bridge to transplant and quality of life for those who are
not transplant candidates. I look forward to larger studies to further confirm the efficacy and safety of LPCN 1148 that was observed
in this study.”
Dr.
Jennifer Lai, MD, MBA, study principal investigator, Professor of Medicine, UCSF, and a practicing general/transplant hepatologist
and board-certified Physician Nutrition Specialist, added, “All of these patients had advanced liver disease awaiting liver transplant
which predisposes them to losing muscle mass. The fact that those who received LPCN 1148 gained muscle mass in a relatively short time
is remarkable. The signals toward improved clinical outcomes, such as hospitalized days and rates of hepatic encephalopathy, are scientifically
plausible effects of having higher muscle mass and are quite promising.”
Cirrhosis
is an end stage liver disease of varying etiologies such as alcoholic liver disease, chronic hepatitis, nonalcoholic fatty liver disease
and primary cholangitis. Complications of cirrhosis include decompensation events such as hepatic encephalopathy due to systemic ammonia
buildup, variceal bleeding, and ascites, which require frequent hospitalizations. Poor Quality of Life (QOL) is common while waiting
for a liver transplant. Although there is a limited supply of donor livers, transplant is the only cure for end-stage cirrhosis. Hepatic
encephalopathy (HE) is a frequent complication and one of the most debilitating manifestations of liver disease, severely affecting the
lives of patients and their caregivers. Furthermore, cognitive impairment associated with cirrhosis results in utilization of more health
care resources in adults than other manifestations of liver disease. LPCN 1148 comprises testosterone dodecanoate, a unique androgen
receptor agonist. It is targeted as a differentiated intervention option with a novel multimodal mechanism of action to elicit potential
benefits in management of cirrhosis and associated comorbidities of cirrhosis.
About
the Phase 2 study
This
multi-center study enrolled and dosed a total of 29 patients across 8 centers in the US. The primary objective was to evaluate the efficacy
of 24 weeks of LPCN 1148 treatment in cirrhotic men with sarcopenia. The secondary objective was to evaluate the safety and tolerability
of LPCN 1148. Baseline characteristics, including age, disease etiology baseline L3-SMI, and other comorbidities were generally well-balanced
between groups. Overall, the average baseline Model for End-Stage Liver Disease (MELD) score was 16.8, and 97% of patients had previously
experienced at least one clinical decompensation event. Sarcopenia, or low muscle mass, was assessed by computed tomography (CT) scan;
total skeletal muscle area was measured by CT scan at the third lumbar vertebra and normalized by subject height (L3-SMI, L3-skeletal
muscle index). Patients had study visits every four weeks, with CTs performed at Week 12 and Week 24. Patients with a variety of cirrhosis
etiologies were eligible. During the study there were no restrictions on standard of care medications, procedures, or other interventions.
Further details on the study design, including inclusion and exclusion criteria, can be found on Clinicaltrials.gov (NCT04874350).
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 13740396. Participants can also click the Call me™ link, https://callme.viavid.com/viavid/?callme=true&passcode=13738729&h=true&info=company&r=true&B=6,
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 products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring
partnering. 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 and LPCN 1148, an oral prodrug of bioidentical testosterone targeted for the management of symptoms
associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm
birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN
1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT). 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 our product development efforts, our product
candidates and related clinical trials, our strategic plans for developing products to treat CNS disorders, our ability to monetize non-core
product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing
new treatments for CNS disorders, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates,
the potential uses and benefits of our product candidates, the potential uses and benefits of LPCN 1148, the timing of and our ability
to make any NDA filing relating to LPCN 1148, . 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 CNS disorders, 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.
For
further information:
Krista
Fogarty
Phone:
(801) 994-7383
kf@lipocine.com
Investors:
PJ
Kelleher
Phone:
(617) 430-7579
pkelleher@lifesciadvisors.com
Exhibit 99.2
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Lipocine (NASDAQ:LPCN)
過去 株価チャート
から 4 2024 まで 5 2024
Lipocine (NASDAQ:LPCN)
過去 株価チャート
から 5 2023 まで 5 2024