Lipocine (LPCN) Reports Positive Topline Phase 2 Results from LPCN 1144 Ongoing LiFT Study in Biopsy-Confirmed NASH Subjects

January 12, 2021 8:01 AM EST

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Lipocine Inc. (NASDAQ: LPCN) today announced positive topline results from its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study (NCT04134091), investigating LPCN 1144 in biopsy-confirmed non-cirrhotic non-alcoholic steatohepatitis ("NASH") male subjects. Currently, there are no approved treatments for NASH, a silent killer that affects ~30 million Americans. LPCN 1144 is an oral prodrug of endogenous testosterone.

In the ongoing randomized, double-blind, placebo-controlled 36-week treatment LiFT study, subjects with F1-F3 fibrosis were randomized 1:1:1 to one of three arms (Treatment A is a twice daily oral dose of 142 mg testosterone equivalent, Treatment B is a twice daily oral dose of 142 mg testosterone equivalent formulated with 217 mg of d-alpha tocopherol equivalent, and the third arm is twice daily matching placebo). The primary endpoint is change in hepatic fat fraction via Magnetic Resonance Imaging Proton Density Fat Fraction ("MRI-PDFF") and exploratory liver fat/marker end points post 12 weeks of treatment. Additionally, key secondary endpoints post 36 weeks of treatment include assessment of histological change for NASH resolution and/or fibrosis improvement as well as liver fat data.

Subjects will have access to LPCN 1144 through an open label extension study (NCT04685993). The extension study will enable the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy

Treatments with LPCN 1144 post 12 weeks of treatment resulted in robust liver fat reduction, assessed by MRI-PDFF, and showed improvement of liver injury markers with no observed tolerability issues. Inclusion of d-alpha tocopherol formulated with the testosterone prodrug resulted in additional liver benefits, notably improved key liver markers without compromising tolerability.

Key results are presented in the following tables:

Table 1. Mean absolute liver fat using MRI-PDFF in all subjects (n=56)* at Week 12.

Treatment

Change from baseline (CBL)

Placebo-adjusted CBL

%

p-value

%

p value

A (n = 18)

-7.7

<0.0001

-6.1

0.0001

B (n = 19)

-9.2

<0.0001

-7.5

<0.0001

Placebo (n = 19)

-1.7

NS

n/a

n/a

* Missing data was obtained using Multiple ImputationNS: Not significant (p > 0.05)

Table 2. Mean relative liver fat using MRI-PDFF at Week 12 in subjects (n=52) with liver fat ≥ 5% at baseline.*

Treatment

Change from baseline (CBL)

Placebo-adjusted CBL

%

p value

%

p value

A (n = 17)

-40.0

<0.0001

-30.0

0.0002

B (n = 17)

-46.9

<0.0001

-37.0

<0.0001

Placebo (n = 18)

-9.9

NS

n/a

n/a

* Based on available data.

Table 3. Responders with > 30% Relative Reduction in Liver Fat at Week 12, Intent to Treat Dataset (n=56)*.

Treatment

Responder

(% of subjects)

p value

vs Placebo

A (n = 18)

66.7

0.0058

B (n = 19)

63.2

0.0026

Placebo (n = 19)

15.8

* Subjects with missing data are considered non-responders

Table 4. Average changes in key serum liver injury markers ALT and AST at Week 12 (n=52)*.

ALT (U/L)

AST (U/L)

Treatment

Absolute

Placebo-AdjustedAbsolute

Absolute

Placebo-AdjustedAbsolute

CBL

p value

vs BL

CBL

p value

vs Placebo

CBL

p value

vs BL

CBL

p value

vs Placebo

A (n = 16)

-9.4

0.0054

-11.1

0.0164

-4.9

0.0402

-7.7

0.0216

B (n = 19)

-22.4

<0.0001

-24.1

<0.0001

-10.4

<0.0001

-13.2

0.0001

Placebo (n = 17)

1.8

NS

n/a

n/a

2.8

NS

n/a

n/a

* All available data

During the 12 weeks of treatment, the observed rate and severity of Treatment Emergent Adverse Events ("TEAEs") in both the treatment arms were comparable to the placebo arm. Three subjects in the placebo group and one subject in the combined treatment arms discontinued study drug due to TEAEs.

"The LiFT study provides the first proof of concept that LPCN 1144 improves both liver fat and markers of liver injury in patients with biopsy proven NASH with fibrosis, with the majority of patients experiencing greater than 30% reduction in liver fat. The addition of d-alpha tocopherol appears to further reduce liver injury in this population. These data appear to support the potential for this novel approach as a treatment of NASH," said Dr. Arun Sanyal, Professor in the Virginia Commonwealth University ("VCU") Department of Internal Medicine and Education Core Director in the VCU Center for Clinical and Translational Research.

"We are pleased by the top-line results from our LiFT study, which we believe demonstrate the potential for oral LPCN 1144's to be used in treating NASH," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. "Additionally, NASH patients are likely to have compromised androgen signaling with associated sarcopenia, skeletal fragility, sexual/mood disorder, and anemia. Therefore, we believe LPCN 1144 therapy has the potential to provide additional benefits such as improved bone density and muscle mass as well as improvement in sexual/mental disorders. We look forward to sharing 36-week biopsy data from the LiFT study in mid-2021," said Dr. Patel.



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