Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session
Lipocine announced the publication of LPCN 1148's Phase 2 clinical trial results in Hepatology journal and its discussion at The Liver Meeting 2024. The study evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. At 24 weeks, LPCN 1148 showed significant improvement in sarcopenia compared to placebo and resulted in fewer episodes of overt hepatic encephalopathy (OHE), despite patients being on background therapies. The treatment also demonstrated beneficial effects on muscle quality, hemoglobin, and patient-reported symptoms. LPCN 1148 is positioned as a potential 'First in Class' product for OHE and sarcopenia indications.
Lipocine ha annunciato la pubblicazione dei risultati del trial clinico di Fase 2 di LPCN 1148 sulla rivista Hepatology e la sua discussione al The Liver Meeting 2024. Lo studio ha valutato LPCN 1148 in uomini con cirrosi e sarcopenia in attesa di trapianto di fegato. Dopo 24 settimane, LPCN 1148 ha mostrato un miglioramento significativo della sarcopenia rispetto al placebo e ha portato a un numero inferiore di episodi di encefalopatia epatica manifesta (OHE), nonostante i pazienti fossero in trattamento con terapie di supporto. Il trattamento ha anche dimostrato effetti benefici sulla qualità muscolare, sull'emoglobina e sui sintomi riferiti dai pazienti. LPCN 1148 è posizionato come un potenziale prodotto 'First in Class' per le indicazioni OHE e sarcopenia.
Lipocine anunció la publicación de los resultados del ensayo clínico de Fase 2 de LPCN 1148 en la revista Hepatology y su discusión en The Liver Meeting 2024. El estudio evaluó LPCN 1148 en hombres con cirrosis y sarcopenia que esperan un trasplante de hígado. Después de 24 semanas, LPCN 1148 mostró una mejoría significativa en la sarcopenia en comparación con el placebo y resultó en menos episodios de encefalopatía hepática manifiesta (OHE), a pesar de que los pacientes estaban bajo tratamientos de fondo. El tratamiento también demostró efectos beneficiosos sobre la calidad muscular, la hemoglobina y los síntomas reportados por los pacientes. LPCN 1148 está posicionado como un potencial producto 'First in Class' para las indicaciones de OHE y sarcopenia.
리포신은 LPCN 1148의 2상 임상 시험 결과를 Hepatology 저널에 발표하고 2024년 The Liver Meeting에서 논의할 것이라고 발표했습니다. 이 연구는 간 이식 대기 중인 간경변과 근감소증이 있는 남성에서 LPCN 1148을 평가했습니다. 24주 후, LPCN 1148은 위약에 비해 근감소증에서 유의미한 개선을 보였고, 환자들이 기본 치료를 받고 있음에도 불구하고 명백한 간성 뇌병증(OHE) 에피소드가 적었습니다. 이 치료는 또한 근육 질, 헤모글로빈 및 환자가 보고한 증상에 긍정적인 효과를 보였습니다. LPCN 1148은 OHE 및 근감소증 적응증을 위한 잠재적인 'First in Class' 제품으로 자리매김하고 있습니다.
Lipocine a annoncé la publication des résultats des essais cliniques de phase 2 de LPCN 1148 dans la revue Hepatology et sa discussion lors de The Liver Meeting 2024. L'étude a évalué LPCN 1148 chez des hommes souffrant de cirrhose et de sarcopénie en attente d'une transplantation hépatique. Après 24 semaines, LPCN 1148 a montré une amélioration significative de la sarcopénie par rapport au placebo et a entraîné moins d'épisodes d'encéphalopathie hépatique manifeste (OHE), malgré le fait que les patients soient sous traitements de fond. Le traitement a également démontré des effets bénéfiques sur la qualité musculaire, l'hémoglobine et les symptômes rapportés par les patients. LPCN 1148 est positionné comme un produit potentiel 'First in Class' pour les indications OHE et sarcopénie.
Lipocine gab die Veröffentlichung der Phase-2-Studienergebnisse zu LPCN 1148 in der Hepatology-Zeitschrift und deren Diskussion auf dem The Liver Meeting 2024 bekannt. Die Studie bewertete LPCN 1148 bei Männern mit Zirrhose und Sarkopenie, die auf eine Lebertransplantation warteten. Nach 24 Wochen zeigte LPCN 1148 eine signifikante Verbesserung der Sarkopenie im Vergleich zum Placebo und führte zu weniger Episoden einer auffälligen hepatischen Enzephalopathie (OHE), obwohl die Patienten gleichzeitig mit Hintergrundtherapien behandelt wurden. Die Behandlung zeigte auch positive Effekte auf die Muskelqualität, das Hämoglobin und die vom Patienten berichteten Symptome. LPCN 1148 wird als potenzielles 'First in Class'-Produkt für die Indikationen OHE und Sarkopenie positioniert.
- LPCN 1148 demonstrated significant improvement in sarcopenia vs placebo
- Treatment showed significant reduction in overt hepatic encephalopathy episodes
- Additional benefits observed in muscle quality, hemoglobin, and patient symptoms
- First pharmacologic agent showing improvements in both sarcopenia and OHE
- None.
Insights
The publication of LPCN 1148's Phase 2 trial results in Hepatology represents a significant milestone with potential market implications. The study demonstrated two key clinical benefits: improved sarcopenia and reduced hepatic encephalopathy episodes in cirrhosis patients. This dual efficacy profile positions LPCN 1148 as a potential first-in-class therapy addressing multiple complications of cirrhosis.
The market opportunity is substantial, considering the unmet medical need in cirrhosis complications. Current standard-of-care treatments typically address single symptoms, while LPCN 1148 shows promise in treating multiple conditions simultaneously. The selection of this research for discussion at The Liver Meeting's Editor's Cut session validates its scientific significance and potential clinical impact.
However, investors should note that this is still early-stage research. The company will need to conduct larger Phase 3 trials to confirm these findings, requiring significant capital investment and time before potential commercialization.
The publication features the results from a Phase 2 proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. The trial was conducted in two stages. Stage 1 was double blind, placebo-controlled with participants randomized 1:1, to receive either oral LPCN 1148 or placebo. This was followed by Stage 2, a 28-week single-arm open label extension. The publication reports the analyses from the Stage 1 readout.
The results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo. Furthermore, despite most participants already on background therapies for HE, participants receiving LPCN 1148 also experienced significantly fewer episodes of overt hepatic encephalopathy (OHE) compared to those on placebo. Additional beneficial effects of LPCN 1148, including improved muscle quality, hemoglobin, and patient reported symptom improvement are also covered in the manuscript.
The publication was discussed at The Liver Meeting during 'The Editors Cut: Clinical Studies' session. This session critically discusses the most notable, influential, cutting edge, game changing clinical research papers published during the past year.
"We are pleased to publish the results from this important proof-of-concept study of LPCN 1148 in Hepatology, a leading peer-reviewed journal," said Benjamin Bruno, Ph.D., Pharm.D., Vice President of Clinical Development at Lipocine and lead author on the publication. "To our knowledge, LPCN 1148 therapy is the first pharmacologic agent to demonstrate improvements in both sarcopenia and overt HE outcomes in patients with cirrhosis. Our findings support further research on the efficacy of LPCN 1148 in managing cirrhosis complications, a critical unmet medical need."
For more information on the study, refer to ClinicalTrials.gov NCT04874350.
About Cirrhosis
Cirrhosis 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 (low muscle mass).
Over 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.
About OHE
OHE is a frequent complication and one of the most debilitating manifestations of liver disease, severely affecting the lives of patients and their caregivers. For patients with decompensated liver cirrhosis and sarcopenia, clinical outcomes tend to be worse - both sarcopenia and myosteatosis are associated with an increased risk of OHE.
OHE is an episodic neurological disorder with a high recurrence rate. Up to
About LPCN 1148
LPCN 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.
About Lipocine
Lipocine 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.
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 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.
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 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.
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SOURCE Lipocine Inc.
FAQ
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