US-based Lipocine is in the works to outline the next development steps for its LPCN 1148 in cirrhosis, CEO Dr Mahesh Patel told Clinical Trials Arena.

The biopharma company plans to meet with the US Food and Drug Administration (FDA) before the end of the year to discuss further development for LPCN 1148 towards a new drug application (NDA).

While the exact development plan is yet to be confirmed with the FDA, Lipocine plans to propose a Phase IIb/III trial. The CEO shared that the first part of the trial would potentially incorporate two-dose testing and move on with the more promising dose into the Phase III part.

Patel said: “Pending resource availability, we would like to start the trial sometime next year, I would say first half.”

The primary endpoint of the trial will potentially look at preventing the reoccurrence of overt hepatic encephalopathy (OHE) and time to the reoccurrence of OHE events in patients with liver cirrhosis. The study is likely to recruit around 200 male patients with cirrhosis in sites based in the US.

LPCN 1148 is an oral prodrug of bioidentical testosterone. As such, Lipocine is currently focused on male participants as the safety and efficacy profile of testosterone is different in females. However, Patel said that the company may consider expanding the drug to female participants in the future.

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By GlobalData

LPCN 1148 in Phase II

Lipocine is about to conclude its open-label extension stage of a Phase II trial and expects to complete dosing in mid-December. The final results from the trial are expected by the end of Q1 in 2024.

In July, Lipocine released positive topline data from the randomised placebo-controlled part of the trial. The data analysis showed that LPCN 1148 met the primary endpoint of the L3 skeletal muscle index (L3-SMI). L3-SMI is a standard measurement to assess sarcopenia in patients with cirrhosis.

Patel said: “We are really excited because for the first time ever our data suggests that improvement in sarcopenia muscle mass leads to decreased hospitalisation time, and that’s a big game changer. That could help us to get a fast track designation with the FDA.”

Pivotal trial in postpartum depression

Lipocine is also working on another pivotal trial with its other asset LPCN 1154 in postpartum depression (PPD). The company plans to start a pivotal trial late this year or early next year. Results from the trial are expected by the end of Q1 2024, with expected NDA filling towards the end of the year.

Using its proprietary technology, Lipocine developed LPCN 1154, which is an oral version of Sage Therapeutics’s IV infusion Zulresso (brexanolone). The upcoming study will be a head-to-head trial with the approved drug to establish matched exposure as the primary endpoint.

The company conducted a pilot study earlier this year. In May, Lipocine released the results and identified the dosing regimen that could match the exposure of Zulresso.