Brexanolone

SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through the pivotal PK bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA filing Topline results from the pivotal PK study are expected late in 2Q 2024. Positive results would support an NDA filing at the end of Q4 2024 LPCN 1148 for Management of Cirrhosis In March 2024, Lipocine announced positive Week 52 results from the LPCN 1148 Phase 2 study in patients with cirrhosis. The study met primary and hepatic encephalopathy endpoints Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Patients on LPCN 1148 therapy had fewer overt hepatic encephalopathy (OHE) events and longer time to first recurrent OHE event, with no OHE background therapy restrictions LPCN 1148 was well-tolerated, with adverse events (AE) rates and severities similar to placebo. Participants on LPCN 1148 were hospitalized for fewer days LPCN 2401 for Obesity Management In April 2024, Lipocine announced positive clinical results from a multi-center prospective, blinded Phase 2 study evaluating LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity Results showed treatment with LPCN 2401 resulted in statistically significant body composition improvements Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% LPCN 2401 was well-tolerated; AEs were similar to placebo. A replay of the webcast discussing the LPCN 2401 Phase 2 results can be accessed on Lipocine's website here Potential for LPCN 2401 to be used in combination with incretin mimetics (GLP-1 agonists and GLP/GIP dual agonists) for improved body composition (ameliorate muscle loss with android fat loss) or as a monotherapy post discontinuation LPCN 2203 for Essential Tremor Oral GABA Positive Allosteric Modulator, targeting improved efficacy with fewer side effects e.g. somnolence, dizziness Daytime efficacy and improved tolerability remains an unmet need Achieved relevant target blood levels with good tolerability in multiple Phase 1 studies with no incidence of somnolence, sedation or dizziness TRT Franchise - TLANDO™ and LPCN 1111 (TLANDO XR) In January 2024, Lipocine and Verity Pharma entered into an exclusive License Agreement under which Verity Pharma will market TLANDO in the United States and, if approved, in Canada. The terms of the license agreement call for a license fee of $11 million and development and sales milestones of up to $259 million in aggregate, dependent on achievement of certain milestones. In addition, the Company is eligible to receive tiered royalty payments ranging from 12% up to 18% on net sales in the U.S. and Canada. First Quarter Ended March 31, 2024 Financial Results Lipocine reported net income of $3.5 million, or $0.66 per diluted share, for the first quarter ended March 31, 2024, compared with a net loss of $3.9 million, or ($0.76) per diluted share, for the quarter ended March 31, 2023. Revenue in the first quarter of 2024 was $7.6 million, primarily consisting of licensing revenue received from the Verity License Agreement. This compares with revenue of $0.06 million in the comparable period in 2023. Research and development expenses were $2.8 million and $3.1 million, respectively, for the quarters ended March 31, 2024 and 2023. The decrease in research and development expenses was a result of a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1148 study late in 2023, a decrease in personnel related costs, and a decrease in LPCN 1111 costs, offset by an increase in costs related to our LPCN 1154 clinical studies, and an increase in other R&D related costs. General and administrative expenses were $1.6 million and $1.3 million, respectively for the quarters ended March 31, 2024 and 2023. The increase in general and administrative expenses was a result of an increase in business development expenses and in other various general and administrative expenses. These increases were offset by a decrease in various administrative consulting fees, a decrease in corporate insurance expense, a decrease in personnel salaries and benefits, and a decrease in legal fees. As of March 31, 2024, Lipocine had $24.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023. 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 partnership 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, LPCN 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 . 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, our strategic plans for developing products to treat CNS disorders, our ability to monetize product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, 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 . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc.

SPT-300 demonstrated nine times greater allopregnanolone exposure in humans dosed orally than published data for oral allopregnanolone,1 validating Glyph™ platform’s ability to enhance oral bioavailability In a Phase 2a trial, SPT-3002 substantially reduced stress-induced levels of cortisol, supporting Seaport’s planned studies in mood and anxiety disorders, including anxious depression BOSTON--(BUSINESS WIRE)-- Seaport Therapeutics, a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced two poster presentations detailing the results from multiple clinical trials of SPT-300 at the Society of Biological Psychiatry (SOBP) Annual Meeting in Austin, TX. SPT-300 has been shown to retain the activity and potency of natural allopregnanolone in an oral form and has the potential to capture the breadth of the naturally occurring neurosteroid, which is believed to have significant therapeutic potential in a range of mood and anxiety disorders, including anxious depression. The presentations detail data from the first-in-human, multi-part Phase 1 trial of SPT-300 and the Phase 2a trial of SPT-300 in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers, and include assessment of safety, tolerability, efficacy, oral bioavailability and GABAA receptor target engagement. “These data summarize some of the evidence supporting the core mechanisms of SPT-300 as we advance to later-stage clinical studies. Our proprietary Glyph™ platform allows SPT-300 to be absorbed like a dietary fat through the intestinal lymphatic system and transported into circulation. We believe this will address allopregnanolone’s naturally low bioavailability but retain its endogenous mechanism and range of potential therapeutic effects,” said Michael Chen, Ph.D., Co-founder and Chief Scientific Officer of Seaport Therapeutics. “These data validate that SPT-300 has the potential to make a difference for patients suffering from depression, anxiety and other neuropsychiatric conditions and also provides further validation for our Glyph platform as an elegant solution to multiple key obstacles in neuropsychiatric drug development.” Details of the poster presentations at SOBP Title: A First-in-Human Phase 1 Study of SPT-300, A First-in-Class Orally Bioavailable Prodrug of the Neurosteroid Allopregnanolone that is Absorbed via the Lymphatic System Presenter: Michael C. Chen, Ph.D. The topline results from the completed, multi-part Phase 1 trial of SPT-300 were reported in December 2022. Overall, the Phase 1 trial was well tolerated and evaluated oral bioavailability, safety, tolerability, pharmacokinetics and GABAA target engagement. This study included double-blind single ascending dose, multiple ascending dose and open-label food effect parts. Allopregnanolone is an endogenous neurosteroid of GABAA positive allosteric modulator with validated anti-depressant and anxiolytic activity, but orally administered allopregnanolone is poorly bioavailable. SPT-300 is absorbed through the intestinal lymphatic system, allowing it to avoid first-pass metabolism. Out of 99 participants enrolled in the first-in-human study, allopregnanolone exposure from SPT-300 was approximately nine times greater than published data for oral allopregnanolone. SPT-300 was generally well-tolerated and resulted in pharmacodynamic effects consistent with GABAA positive allosteric modulation. The pharmacodynamic and pharmacokinetic properties demonstrated warrant further clinical development. No treatment-related severe or serious adverse events (AE) were reported, and the most common AE was somnolence, which was mild in all cases. Title: SPT-300, an Oral Prodrug of Allopregnanolone, Potentially Reduces Salivary Cortisol Response to the Trier Social Stress Test in a Randomized, Placebo-Controlled Trial in Healthy Participants Presenter: Michael C. Chen, Ph.D. The topline results from Seaport’s SPT-300 Phase 2a proof-of-concept trial were reported in November 2023. The potential of SPT-300 to reduce physiological stress was tested in a randomized, placebo-controlled study using the TSST, a validated clinical model of anxiety in healthy volunteers exposed to unpredictable, novel, anticipatory and social stress. Among the enrolled healthy volunteers, SPT-300 substantially reduced salivary cortisol at all post-TSST timepoints compared to placebo and SPT-300 treated participants had significantly reduced cortisol versus placebo from baseline to peak (p=0.0001), meeting the study’s primary endpoint and demonstrating that SPT-300 regulates hypothalamic-pituitary-adrenal axis reactivity to acute stress. The most common treatment-emergent adverse event was somnolence (29% SPT-300 vs. 13% placebo), which was transient and mild or moderate. SPT-300 was generally well-tolerated and demonstrated GABA modulatory pharmacological activity that merits further investigation in stress-related mood and anxiety disorders, including anxious depression. About SPT-300 SPT-300 (Glyph-allopregnanolone), an oral prodrug of allopregnanolone, an endogenous neurosteroid, is in clinical stage development for the treatment of mood and anxiety disorders, including anxious depression. Allopregnanolone has demonstrated therapeutic benefit in a range of neuropsychiatric conditions, but it is only approved as an intravenous infusion, which has limited the scope of its clinical use. Using the Glyph platform, SPT-300 retains the activity and potency of endogenous allopregnanolone in an oral form and has the potential to capture the breadth of the natural biological response. In a Phase 2a clinical trial, SPT-300 demonstrated proof-of-concept in a validated clinical model of anxiety in healthy volunteers. SPT-300 also demonstrated oral bioavailability, tolerability and γ-aminobutyric-acid type A (GABAA) receptor target engagement in healthy volunteers in a Phase 1 clinical trial. About the Glyph™ Platform Glyph is Seaport's proprietary technology platform which uses the lymphatic system to enable and enhance the oral administration of drugs. With the Glyph platform, drugs are absorbed like dietary fats through the intestinal lymphatic system and transported into circulation. Seaport believes the Glyph technology has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism leading to low bioavailability and/or side effects, including hepatotoxicity. The Glyph platform has been refined at Seaport to efficiently generate multiple therapeutic candidates within the company’s pipeline. Seaport has exclusively licensed this technology from Monash University based on the pioneering research of the Porter research group, along with the co-inventors from PureTech Health and Seaport. The group and its collaborators have published research in Nature Metabolism, Frontiers in Pharmacology and the Journal of Controlled Release supporting the Glyph platform's capabilities. About Seaport Therapeutics Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph™ technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit . Footnotes 1 U.S. Food and Drug Administration. (2018). FDA drug approval package: Zulresso (Application No. 211,371) 2 SPT-300, formerly known as LYT-300 View source version on businesswire.com: Contacts Seaport Therapeutics publicrelations@seaporttx.com Media Nichole Bobbyn +1 774 278 8273 nichole@tenbridgecommunications.com Source: Seaport Therapeutics View this news release online at: