Full Press Release Details
Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated
LAKE CITY, Dec. 17, 2024 - 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.
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."
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
| 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 |
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
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.
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.
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.
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.
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.
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.
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.
further information: