Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154
Lipocine Inc. announced the completion of dosing in a pivotal study for LPCN 1154, an oral brexanolone for postpartum depression. The study aims for NDA submission in 2024, with topline results expected in 2Q 2024. Market expansion for PPD treatment is anticipated due to increased awareness. The FDA has accepted a proposal for NDA filing based on a single pivotal PK study.
The completion of dosing in the pivotal study for LPCN 1154 is a positive development for Lipocine Inc.
Topline results are anticipated in late 2Q 2024, aligning with the company's goal for NDA submission by the end of 2024.
The market size for postpartum depression treatment is larger than previously estimated, indicating potential growth opportunities for LPCN 1154.
Increased awareness of postpartum depression is expected to lead to higher diagnosis rates and more patients seeking treatment, benefiting LPCN 1154.
There may be challenges in the regulatory approval process despite the alignment with the FDA on a streamlined pathway to NDA submission.
The company's success depends on the topline results of the study, which are yet to be disclosed.
Competition in the postpartum depression treatment market could impact the market potential for LPCN 1154.
Lipocine's announcement on the completion of dosing in their pivotal study of LPCN 1154 for postpartum depression (PPD) signifies a potential advance in the treatment options for this condition. The pharmaceutical landscape for PPD has been relatively stagnant, making this development noteworthy for its potential to address a significant unmet medical need.
The proposal for a 505(b)(2) NDA filing is a strategic regulatory pathway, wherein Lipocine is leveraging existing clinical data from a similar, already-approved drug. This could expedite the approval process and reduce development costs. For investors, this suggests a calculated risk approach to bringing a product to market. The target market, estimated to affect 500,000 women annually in the U.S. alone, offers a substantial patient population that could translate into a significant revenue stream, pending LPCN 1154's efficacy and safety profile as demonstrated in the upcoming topline results.
The impact of new treatments on the stock market can often hinge on the potential market size and the severity of the unmet need. For LPCN 1154, the expanded awareness and diagnosis rates of PPD indicate a growing market. This scenario is often favorable for biopharmaceutical companies, as it suggests an opportunity for market expansion and increased demand for innovative treatments.
With Lipocine's confirmation of FDA acceptance for their NDA strategy, investors might interpret this as a positive signal of regulatory confidence. However, the stock's performance will likely remain volatile until the release of the topline results and the subsequent NDA submission. Long-term value will depend on market penetration, competitive landscape and the ability to secure favorable reimbursement arrangements with insurers.
Pivotal study design aligned with FDA on streamlined pathway to NDA submission goal in 2024
Topline results anticipated late in 2Q 2024
"We are pleased to complete dosing of participants in this NDA enabling study of LPCN 1154," said Dr. Mahesh Patel, President and CEO of Lipocine. "We look forward to reporting topline results from this study late in the second quarter of 2024."
PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting for up to 12 months after childbirth. There is an unmet need for an oral fast-acting product with an improved efficacy and safety profile to treat PPD. Oral LPCN 1154, comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing, is being developed to provide rapid relief with robust efficacy.
Recent reports suggest that the market size for PPD is larger than previously estimated. Approximately 500,000 women are affected by PPD annually in
Lipocine has confirmed with the
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of postpartum depression (PPD). Brexanolone is a bioidentical to naturally occurring neuro active steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.
About Postpartum Depression and Unmet Needs
PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. 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 combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis including prevention of the recurrence of overt hepatic encephalopathy. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, LPC 2401 for obesity management 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 our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the timing and outcome of product studies, our development of and filing of an 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.
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