Full Press Release Details
Lipocine to Present LPCN 1148 and LPCN 1144 at the
Phase 2 proof-of-concept study of LPCN 1148 in male
cirrhotic patients with sarcopenia is fully enrolled with topline 24-week results expected mid-2023
SALT LAKE CITY, June 7, 2023 - Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary
technology platform to develop differentiated products, today announced that it will present posters on LPCN 1148 and LPCN 1144 at the
forthcoming European Association for the Study of the Liver (EASL) Congress 2023, to take place in Vienna, Austria, June 21 -
A multimodal treatment candidate for sarcopenia
in men with decompensated cirrhosis: a randomized, placebo-controlled trial evaluating LPCN 1148
Lead author and presenter: Dr. Benjamin J.
Bruno, Senior Director of Clinical Development at Lipocine
Cirrhosis and its complications: Other clinical complications except ACLF and critical illness
Date and Time: Wednesday, 21 June, 9:00
Efficacy and safety of LPCN 1144 in hypogonadal
and eugonadal subjects for the treatment of nonalcoholic steatohepatitis (NASH) with fibrosis
Lead author and presenter: Dr. Benjamin J.
Bruno, Senior Director of Clinical Development at Lipocine
Date and Time: Friday, 23 June, 9:00
Selected for Poster Tour presentation
Dr. Bruno will give a live presentation of this
poster followed by a Q&A session during the Poster Tour on June 24th at 15:30-16:15 at the Metabolism, Alcohol, and Toxicity
The posters will be available on Lipocine's
corporate website following the meeting.
LPCN 1148 is a novel androgen
receptor agonist prodrug for oral administration with compelling multi modal action to improve liver and muscle function, resulting in
improved quality of life while awaiting liver transplant, decreased hospital admissions, and prevention or reduction in occurrence and
recurrence of decompensation events.
LPCN 1144, a novel androgen
receptor agonist prodrug for oral administration, is being developed as a treatment for pre-cirrhotic non-alcoholic steatohepatitis (NASH)
and recently completed a Phase 2 paired biopsy clinical study (LiFT or Liver Fat intervention with oral Testosterone).
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.
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, 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, LPCN1154, for rapid relief of postpartum depression, 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, the application
of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, 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.
For further information:
Phone: (801) 994-7383
Phone: (617) 430-7579