FDA Fast-Tracks Lipocine’s LPCN 1148 for Sarcopenia in Cirrhosis

Lipocine Inc., a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) phase 2 study in patients with decompensated cirrhosis.  Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes.  LPCN 1148 is targeted to be a ""First in Class"" product candidate with a novel mechanism of action for management of cirrhosis.

We are excited the FDA has recognized that sarcopenia in patients with cirrhosis is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists,"" said Dr. Mahesh Patel, president and chief executive officer of Lipocine. ""We are encouraged that the positive primary endpoint results from our successful proof-of-concept study were recognized by the FDA as evidence of clinical effectiveness of LPCN 1148 in improving sarcopenia in patients with cirrhosis.

The Fast Track programme is designed to accelerate the development and expedite the review of products, such as LPCN 1148, which are intended to treat serious diseases and for which there is an unmet medical need.  Fast Track designation lends eligibility for some, or all, of the following:

    • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

    • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

    • Eligibility for Accelerated Approval and Priority Review if relevant criteria are met

    • Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed

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.

Sarcopenia, a progressive loss of muscle mass and function, is a common and debilitating complication in patients with decompensated cirrhosis. It significantly impacts quality of life and worsens clinical outcomes, including reduced survival rates.

Patients with decompensated cirrhosis and sarcopenia exhibit significantly shorter overall survival than those without sarcopenia. Currently, the only curative therapy for decompensated cirrhosis is liver transplant. There are no FDA approved drugs to treat sarcopenia in decompensated cirrhosis beyond treatment of the underlying conditions.

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.

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 

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