SALT
LAKE CITY, Dec. 17, 2024 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery, today announced that the U.S. Food and
Drug Administration ("FDA") has granted Fast Track Designation to
LPCN 1148 as a treatment for sarcopenia in patients with
decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical
testosterone, was recently studied in a proof-of-concept (POC)
Phase 2 study in patients with decompensated cirrhosis.
Treatment with LPCN 1148 in the POC study improved
sarcopenia and associated clinical outcomes. LPCN 1148 is
targeted to be a "First in Class" product candidate with a novel
mechanism of action for management of cirrhosis.
"We are excited the FDA has recognized that sarcopenia in
patients with cirrhosis is a serious condition and that LPCN 1148
has the potential to provide clinical benefits for these patients
where no therapy currently exists," said Dr. Mahesh Patel,
President and Chief Executive Officer of Lipocine. "We are
encouraged that the positive primary endpoint results from our
successful proof-of-concept study were recognized by the FDA as
evidence of clinical effectiveness of LPCN 1148 in improving
sarcopenia in patients with cirrhosis."
The Fast Track program is designed to accelerate the development
and expedite the review of products, such as LPCN 1148, which are
intended to treat serious diseases and for which there is an unmet
medical need. Fast Track designation lends eligibility for
some, or all, of the following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials and use of
biomarkers
- Eligibility for Accelerated Approval and Priority Review if
relevant criteria are met
- Rolling Review, which means that a drug company can submit
completed sections of its New Drug Application (NDA) for review by
FDA, rather than waiting until every section of the NDA is
completed before the entire application can be reviewed
About Cirrhosis
Cirrhosis is an end stage liver disease of varying etiologies
such as alcoholic liver disease, chronic viral 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. In addition, many patients
exhibit sarcopenia (low muscle mass).
Over 382,000 patients have been diagnosed with decompensated
liver cirrhosis in the US, with few options for managing their
disease other than liver transplant. Poor quality of life 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.
About Sarcopenia
Sarcopenia, a progressive loss of muscle mass and function, is a
common and debilitating complication in patients with decompensated
cirrhosis. It significantly impacts quality of life and worsens
clinical outcomes, including reduced survival rates.
Patients with decompensated cirrhosis and sarcopenia exhibit
significantly shorter overall survival than those without
sarcopenia. Currently, the only curative therapy for decompensated
cirrhosis is liver transplant. There are no FDA approved drugs to
treat sarcopenia in decompensated cirrhosis beyond treatment of the
underlying conditions.
About LPCN 1148
LPCN 1148 comprises testosterone dodecanoate, a unique androgen
receptor agonist. It is targeted as a differentiated intervention
option with a novel multimodal MOA to elicit potential benefits in
management of cirrhosis and associated comorbidities of
cirrhosis.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated products.
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 anabolic androgen receptor
agonist, as an adjunct therapy to incretin mimetics, as an aid for
improved body composition in obesity management and LPCN 1148, a
novel androgen receptor agonist prodrug for oral administration
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
1154, for rapid relief of postpartum depression, LPCN 2401 for
obesity management, 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 development and commercialization of
TLANDO and TLANDO XR (LPCN 1111) by our licensees, the amount of
the license fee, milestone payments, and royalty payments we will
ultimately receive, the ability of our licensees to grow the TLANDO
franchise, our product development efforts, the application of our
proprietary platform in developing new treatments for CNS
disorders, our product candidates and related clinical trials, our
development of our product candidates and related efforts with the
FDA, including with respect to LPCN 1148 and LPCN 2401, the timing
of our submission of a NDA with the FDA for LPCN 1154, and the
potential uses and benefits of our 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 CNS 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.
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SOURCE Lipocine Inc.
