testosterone prodrug (LPCN 1144) / Lipocine - LARVOL DELTA

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Lipocine Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Efficacy and safety of LPCN 1144 in hypogonadal and eugonadal subjects for the treatment of nonalcoholic steatohepatitis (NASH) with fibrosis (EASL-ILC 2023) - "The efficacy and safety of LPCN 1144 therapy for treatment of NASH in male patients is independent of basal gonadal status. These data suggest that oral LPCN 1144 treatment is a safe and effective therapy for the male NASH population which is comprised of both hypogonadal and eugonadal patients. The observed benefit to risk profile warrants further investigation of LPCN 1144 in a larger trial with a longer duration."

Clinical • Benign Prostatic Hyperplasia • Cardiovascular • Endocrine Disorders • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Non-alcoholic Steatohepatitis • Oncology • Pruritus • Solid Tumor

Efficacy and safety of LPCN 1144 in hypogonadal and eugonadal subjects for the treatment of nonalcoholic steatohepatitis (NASH) with fibrosis (EASL-ILC 2023) - "The efficacy and safety of LPCN 1144 therapy for treatment of NASH in male patients is independent of basal gonadal status. These data suggest that oral LPCN 1144 treatment is a safe and effective therapy for the male NASH population which is comprised of both hypogonadal and eugonadal patients. The observed benefit to risk profile warrants further investigation of LPCN 1144 in a larger trial with a longer duration."

Clinical • Benign Prostatic Hyperplasia • Cardiovascular • Endocrine Disorders • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Non-alcoholic Steatohepatitis • Oncology • Pruritus • Solid Tumor

[VIRTUAL] Oral LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects: Results of a Phase 2 randomized controlled study (EASL-ILC 2021) - P2 | "LPCN 1144 treatment substantially and significantly improved the key non-invasive markers of liver health in male patients with biopsy confirmed NASH with fibrosis. LPCN 1144’s treatment potential for NASH resolution and/or fibrosis improvement is under evaluation in the ongoing LiFT trial."

Clinical • P2 data • Addiction (Opioid and Alcohol) • Fibrosis • Hepatology • Immunology • Liver Failure • Non-alcoholic Steatohepatitis • Transplantation • MRI

[VIRTUAL] LPCN 1144 improves body composition in biopsy-confirmed NASH patients (EASL-ILC 2021) - P2 | "LPCN 1144 significantly improved BC in biopsyconfirmed NASH male subjects. The forthcoming w36 data in the ongoing LiFT trial is expected to further elucidate the effects of LPCN 1144 on changes in BC. This significant impact of LPCN 1144 on BC can be beneficial in cirrhotic subjects."

Clinical • Late-breaking abstract • Hepatology • Non-alcoholic Steatohepatitis • Sarcopenia • Transplantation

[VIRTUAL] High prevalence of low normal or overtly hypogonadal levels of testosterone observed in histologically established NASH subjects in LiFT Study (EASL-ILC 2021) - P2 | "Currently, LPCN 1144 is being investigated for safety and efficacy in a phase 2 LiFT ("Liver Fat intervention with oral Testosterone") study (NCT04134091)... The LiFT study demonstrates a high prevalence of low- normal or overtly hypogonadal levels of T in biopsied patients with suspected or established NASH. A significant portion of NASH subjects may have undiagnosed hypogonadism or low T. Apparently, male adult NASH patients are likely to have compromised androgen signaling with possible associated symptoms of androgen deficiency such as sarcopenia, skeletal fragility, sexual/mood dis- order, and/or anemia. Men with NAFLD/NASH should be routinely screened for hypogonadism and vice versa."

Clinical • Addiction (Opioid and Alcohol) • Anemia • CNS Disorders • Endocrine Disorders • Fibrosis • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Hepatology • Liver Cancer • Non-alcoholic Steatohepatitis • Oncology • Sarcopenia • Solid Tumor • AR

[VIRTUAL] Oral LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects: Results of a Phase 2 randomized controlled study (EASL-ILC 2021) - P2 | "LPCN 1144 treatment substantially and significantly improved the key non-invasive markers of liver health in male patients with biopsy confirmed NASH with fibrosis. LPCN 1144’s treatment potential for NASH resolution and/or fibrosis improvement is under evaluation in the ongoing LiFT trial."

Clinical • P2 data • Addiction (Opioid and Alcohol) • Fibrosis • Hepatology • Immunology • Liver Failure • Non-alcoholic Steatohepatitis • Transplantation • MRI

QUANTITATIVE DIGITAL PATHOLOGY AND IMAGING METHODS DEMONSTRATE THE CONSISTENT REDUCTION OF LIVER FAT BURDEN IN PATIENTS TREATED WITH LPCN 1144 (AASLD 2022) - P2 | "LPCN 1144, both alone and in combination with d-alpha tocopherol, demonstrates a strong antisteatotic effect. Digital Pathology and Imaging methods for the assessment of these effects provides robust support of the pathologist-based results."

Clinical • Fibrosis • Hepatology • Immunology • Non-alcoholic Steatohepatitis

HISTOLOGIC ASSESSMENT BY PATHOLOGISTS AND DIGITAL PATHOLOGY DESCRIBE THE ANTIFIBROTIC EFFECT OF LPCN1144 (AASLD 2022) - P2 | "Results of this proof-of-concept study support potential antifibrotic effects of LPCN 1144, which require confirmation in a larger and longer study."

Addiction (Opioid and Alcohol) • Fibrosis • Hepatology • Immunology • Non-alcoholic Steatohepatitis

EFFICACY, SAFETY, AND TOLERABILITY OF CONTINUED LPCN 1144 TREATMENT IN NONALCOHOLIC STEATOHEPATITIS (NASH) SUBJECTS WITH FIBROSIS IN AN OPEN LABEL EXTENSION STUDY (OLE) (AASLD 2022) - "LPCN 1144 was well tolerated over 72-week exposure with no observed safety signals. Liver injury markers were reduced significantly (p<0.05) and maintained with the extended treatment. The tolerability with no adverse safety signals, combined with efficacy results over an extended treatment duration support further development."

Clinical • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Non-alcoholic Steatohepatitis

Lipocine reports positive LPCN 1144 NASH open label extension study results (Pharmabiz) - "'The tolerability with no adverse safety signals and efficacy results of LPCN 1144 over extended treatment duration are promising. These data provides strong rationale for further development of this novel approach as a treatment for NASH,' said Dr. Arun Sanyal..."

Media quote

SAFETY AND TOLERABILITY OF LPCN 1144 TREATMENT IN BIOPSY CONFIRMED NASH SUBJECTS IN THE PHASE 2 LIFT STUDY (NASH-TAG 2022) - P2 | "LPCN 1144 was well-tolerated in biopsy confirmed NASH male subjects, with no observed signs of adverse androgenic effects, increased cardiovascular or hepatic risks. The observed benefit to risk profile warrants further investigation of LPCN 1144 in a larger trial with a longer duration."

Clinical • P2 data • Cardiovascular • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Failure • Myocardial Infarction • Non-alcoholic Steatohepatitis • Obstructive Sleep Apnea • Oncology • Pruritus • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Solid Tumor • Transplantation

LPCN 1144 IMPROVES BODY COMPOSITION IN BIOPSY-CONFIRMED NASH PATIENTS (NASH-TAG 2022) - P2 | "LPCN 1144 significantly improved BC in biopsy-confirmed NASH male subjects. The forthcoming w36 data in the ongoing LiFT trial is expected to further elucidate the effects of LPCN 1144 on changes in BC. This significant impact of LPCN 1144 on BC can be beneficial in cirrhotic subjects."

Clinical • Hepatology • Non-alcoholic Steatohepatitis • Sarcopenia • Transplantation

LPCN 1144 THERAPY DEMONSTRATES HISTOLOGIC BENEFITS IN THE PHASE 2 LIFT STUDY IN NONALCOHOLIC STEATOHEPATITIS (NASH) SUBJECTS (NASH-TAG 2022) - P2 | "LPCN 1144 resolved NASH with no worsening of fibrosis, improved liver injury markers, and reduced liver fat in men with biopsy confirmed NASH and fibrosis in the LiFT study. LPCN 1144 was well tolerated, with rates and severity of AEs similar in all arms. These data support the potential for this novel approach as a treatment of NASH."

Clinical • P2 data • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Non-alcoholic Steatohepatitis

"$LPCN Lipocine Announces Regulatory Guidance on LPCN 1144 in Non-cirrhotic NASH https://t.co/eaQkbi9YA1" (@stock_titan)

Hepatology • Non-alcoholic Steatohepatitis

LiFT: A Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=56 | Completed | Sponsor: Lipocine Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2021 ➔ Jun 2021

Trial completion • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Lipocine Inc. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Hepatology • Non-alcoholic Steatohepatitis

[VIRTUAL] LPCN 1144 THERAPY DEMONSTRATES HISTOLOGIC BENEFITS IN THE PHASE 2 LIFT STUDY IN NONALCOHOLIC STEATOHEPATITIS (NASH) SUBJECTS (AASLD 2021) - P2 | "LPCN 1144 resolved NASH with no worsening of fibrosis, improved liver injury markers, and reduced liver fat in men with biopsy confirmed NASH and fibrosis in the LiFT study. LPCN 1144 was well tolerated, with rates and severity of AEs similar in all arms. These data support the potential for this novel approach as a treatment of NASH."

Clinical • Late-breaking abstract • P2 data • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Non-alcoholic Steatohepatitis • MRI

[VIRTUAL] SAFETY AND TOLERABILITY OF LPCN 1144 TREATMENT IN BIOPSY CONFIRMED NASH SUBJECTS IN THE PHASE 2 LIFT STUDY (AASLD 2021) - P2 | "LPCN 1144 was well-tolerated in biopsy confirmed NASH male subjects, with no observed signs of adverse androgenic effects, increased cardiovascular or hepatic risks. The observed benefit to risk profile warrants further investigation of LPCN 1144 in a larger trial with a longer duration."

Clinical • Late-breaking abstract • P2 data • Cardiovascular • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Failure • Myocardial Infarction • Non-alcoholic Steatohepatitis • Obstructive Sleep Apnea • Oncology • Pruritus • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Solid Tumor • Transplantation

[VIRTUAL] LPCN 1144 IMPROVES BODY COMPOSITION IN BIOPSY- CONFIRMED NASH PATIENTS (AASLD 2021) - P2 | "LPCN 1144 significantly improved BC in biopsy-confirmed NASH male subjects . The forthcoming w36 data in the ongoing LiFT trial is expected to further elucidate the effects of LPCN 1144 on changes in BC. This significant impact of LPCN 1144 on BC can be beneficial in cirrhotic subjects."

Clinical • Hepatology • Non-alcoholic Steatohepatitis • Sarcopenia • Transplantation

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (clinicaltrials.gov) - P2; N=20; Enrolling by invitation; Sponsor: Lipocine Inc.; Trial completion date: Oct 2021 ➔ Aug 2022; Trial primary completion date: Jun 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis

Lipocine announces positive results for LPCN 1144 treatment in NASH (Healio) - "'The extent of the LPCN 1144 efficacy results in meeting the NASH resolution regulatory endpoint from the LiFT study are striking with no adverse safety signal,' Arun Sanyal, MD...'These data strongly support further development of this differentiated novel approach as a treatment of NASH.'"

Media quote

[VIRTUAL] Low Testosterone in Males May Warrant Liver Health Assessment and Intervention (ENDO 2021) - P3 | "The objective of this investigation was to evaluate prevalence of liver disease in hypogonadal males, and to assess for potential beneficial effects of LPCN 1144, a novel oral T therapy candidate, on liver health of hypogonadal males...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Addiction (Opioid and Alcohol) • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Diabetes • Dyslipidemia • Fibrosis • Genetic Disorders • Hepatology • Hypertension • Immunology • Inflammation • Liver Failure • Metabolic Disorders • Non-alcoholic Steatohepatitis • Obesity • Obstructive Sleep Apnea • Peripheral Arterial Disease • Psychiatry • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Treatment potential of LPCN 1144 on liver health and metabolic regulation in a non-genomic, high fat diet induced NASH rabbit model. (PubMed, J Endocrinol Invest) - "Histological and biomarker analyses demonstrate that LPCN 1144 improved HFD-induced hepatic fibrosis and NASH biochemical, biomolecular and histochemical features. These preclinical findings support a therapeutic potential of LPCN 1144 in the treatment of NASH and of hepatic fibrosis."

Journal • Preclinical • Addiction (Opioid and Alcohol) • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Non-alcoholic Steatohepatitis

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (clinicaltrials.gov) - P2; N=20; Enrolling by invitation; Sponsor: Lipocine Inc.

Clinical • New P2 trial • Hepatology • Non-alcoholic Steatohepatitis