Lipocine: It’s All About Tlando, NASH & Patent Trial

Lipocine Inc.’s (LPCN) TLANDO, an oral testosterone product candidate, is back at the FDA altar again, with a decision date now set for August 28, 2020.

TLANDO is proposed as a testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The global Male Hypogonadism market, which was worth $3139.6 million in 2019, is estimated to reach $3448.5 million by 2025, according to a report by Market Study Report.

The FDA had refused to approve TLANDO thrice before – in June 2016, citing deficiencies related to the dosing algorithm for the proposed label, in May 2018, saying that the product could not be approved in its current form, and in November 2019, citing the failure of the efficacy trial to meet the three secondary endpoints for maximal testosterone concentrations (“Cmax”).

During a Post Action meeting in February of this year, the FDA agreed that Lipocine’s approach to addressing the concerns raised in the November 2019 Complete response Letter through the reanalysis of existing data is a reasonable path forward.

Accordingly, the Company resubmitted the NDA for TLANDO, including the information generated by the reanalysis, which has now been accepted for review.

Will TLANDO make it to the finish line at least this time?

Meanwhile, the Company is embroiled in a patent infringement lawsuit with Clarus Therapeutics. The suit alleges that Clarus’ Jatenzo, an oral testosterone capsule to treat men with certain forms of hypogonadism, infringes six of Lipocine’s US patents. Jatenzo, which was launched in the U.S. last month, is the first new oral testosterone replacement product in over 60 years.

The patent trial is set to begin on August 24, 2020.

TLANDO is not the only drug in Lipocine’s pipeline. LPCN 1144, an oral prodrug of bioidentical testosterone, is being developed as a treatment for pre-cirrhotic non-alcoholic steatohepatitis. This compound is under a phase II study in confirmed pre-cirrhotic non-alcoholic steatohepatitis (“NASH”) subjects, dubbed LiFT.

Top-line primary endpoint liver fat reduction data are currently expected in mid-2020.

The Company, which ended September 30, 2019, with unrestricted cash, cash equivalents and marketable securities aggregating $11.5 million, raised gross proceeds of about $6.0 million in a public offering last November.

LPCN closed Wednesday’s trading at $0.57, up 6.09%.

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