- The stock price of Lipocine (LPCN) fell by 10.41% in the most recent trading session. This is why.
The stock price of Lipocine (LPCN) fell by 10.41% in the most recent trading session.
Why: Lipocine announced its plans to focus on treating CNS disorders.
New strategic direction focused on CNS: Lipocine’s priority is to advance its pipeline of endogenous neuroactive steroids (NAS). And NAS have been shown to impact central nervous system function largely through allosteric modulation of the GABAA receptor. As a novel drug class, NAS have received considerable attention because of their potential to treat various neuropsychiatric conditions including depression, movement disorders, epilepsy, anxiety, and neurodegenerative diseases.
Lipocine believes that its technology can be applied to enable effective oral delivery of endogenous modulators of the GABAA receptor, which historically have been challenging to deliver orally due to poor aqueous solubility. And the CNS development portfolio includes LPCN 1154, a fast-acting oral antidepressant for postpartum depression (PPD) with potential for outpatient use; LPCN 2101, with a novel mechanism of action, for women with epilepsy; and additional undisclosed CNS-focused candidates.
LPCN 1154: Lipocine’s most advanced NAS candidate is LPCN 1154, a non-invasive, oral formulation of the neurosteroid brexanolone which the company is developing for the treatment of PPD. Lipocine recently announced that the U.S. Food and Drug Administration (“FDA”) has agreed with the Company’s proposal for establishing the efficacy of LPCN 1154 through a pivotal pharmacokinetic (“PK”) bridge to an approved IV infusion brexanolone via a 505(b)(2) NDA filing. The pilot PK bridge study (a prelude to a pivotal study required for NDA filing) is ongoing with results expected in the first quarter of 2023.
Planned monetization of non-core assets: Lipocine has developed a portfolio of clinical stage candidates including LPCN 1144 for treatment of non-cirrhotic NASH, LPCN 1148 for decompensated liver cirrhosis, LPCN 1107 for prevention of pre-term birth, and LPCN 1111, a once-a-day therapy for TRT. The Company intends to advance these programs further through partnerships, a strategy that is designed to diversify risk and potentially create opportunities for non-dilutive financing. And as a result, no further significant investment is expected for these programs. The company plans to complete the ongoing Phase 2 proof-of-concept study for LPCN 1148 in liver cirrhosis and continues to explore ex-U.S. commercialization of FDA approved TLANDO through partnering.
“We are excited to announce a new strategic direction for Lipocine, which involves applying our validated Lip’ral technology to develop new treatments for CNS disorders. Our initial focus is on endogenous neuroactive steroids which have broad applicability in treating various CNS conditions and where we can leverage our platform to develop highly differentiated oral therapeutics.”
“The changes we are implementing allow us to focus on a select number of candidates in active development and to manage our resources efficiently. We continue to believe in the value of our non-core candidates and have determined that the optimal way to advance these assets will be through partnership. We believe that this strategy will allow us to diversify risk and can create opportunities for non-dilutive financing.”
— Dr. Mahesh Patel, President and CEO of Lipocine