Lipocine Reports Positive Topline Clinical Results Supporting Streamlined Development Pathway for LPCN 1154

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Lipocine Reports Positive Topline Clinical Results Supporting Streamlined Development Pathway for LPCN 1154

Lipocine Inc. (NASDAQ: LPCN ), today announced positive topline results from a pilot clinical PK bridge study of LPCN 1154 (oral brexanolone) with a comparator, IV brexanolone. The pilot study is an important step in Lipocine's ongoing program to develop LPCN 1154 for PPD. Lipocine is a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products.

PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. LPCN 1154 is targeted to be a differentiated oral option with rapid-onset, robust efficacy, and short treatment duration as a mono or add-on therapy for patients with unresolved depression symptoms.

Study Design and Results

The pilot PK bridge study was an open label, randomized, partial crossover study in healthy postmenopausal women. The primary objective of the study was to compare the PK (AUC and Cmax) of two LPCN 1154 oral multi-dose regimens (DR 1: dosing regimen 1 for 3.5 days, DR 2: dosing regimen 2 for 2.5 days) and a continuous IV infusion dosing regimen of brexanolone (per label for 2.5 days, up to 90 µg/kg/hr), to inform the dose selection for the planned confirmatory pivotal PK registration study. The secondary objective was to evaluate the safety and tolerability of multidose regimens of LPCN 1154. The study enrolled a total of twelve participants and was conducted at a single phase 1 unit in the US.

Ratios (%) of geometric mean - LPCN 1154 regimens vs IV brexanolone regimens:

PK Parameter

DR 1 vs
IV 60 µg*

DR 1 vs
IV 90 µg

DR 2 vs
IV 60 µg*

DR 2 vs
IV 90 µg

AUC

98 %

77 %

106 %

83 %

Cmax

114 %

68 %

134 %

79 %

60 µg and 90 µg refer to the maximum dose in the IV regimen (60 µg/kg/hr and 90 µg/kg/hr). *Interpolated from 90 µg/kg/hr IV infusion data

  • DR 1 regimen resulted in comparable brexanolone exposure (Cmax and AUC) to IV brexanolone 60 µg/kg/hr regimen
  • DR 2 regimen resulted in exposure levels (Cmax and AUC) within the two clinically-effective IV brexanolone dosing regimens (60 µg/kg/hr and 90 µg/kg/hr)
  • Dosing regimen identified for confirmatory PK study

Consistent with prior experience, LPCN 1154 appeared safe and well-tolerated in this study. All AEs were mild or moderate in severity, and similar across trial arms. No hypoxia, sedation-related, or serious adverse events were observed.

The U.S. Food and Drug Administration (FDA) has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 in women with PPD through a clinical PK bridge to the approved IV infusion of brexanolone via anticipated 505(b)(2) NDA filing and streamlined approval pathway. Lipocine plans to initiate a single confirmatory pivotal PK study in the second half of 2023 to establish efficacy, pending FDA feedback.

"The encouraging positive results from this pilot PK bridge study support our development plan for LPCN 1154," said Dr. Mahesh Patel, President and CEO of Lipocine. "The days and weeks after childbirth are critical time periods for the care of both mother and newborn. PPD is a serious condition in need of a highly effective, oral, fast-acting and short treatment duration option. We believe rapid relief matters and, if approved, LPCN 1154 has the potential to be a differentiated preferred treatment for PPD."

Conference Call and Webcast

Lipocine management will host a conference call and webcast with slides beginning at 8:30 a.m. Eastern Time today to discuss the clinical bridge study results and answer questions. To participate via telephone, please dial 1-877-451-6152 or 1-201-389-0879 (ex-U.S. toll dial-in number) using the conference ID 13738729. Participants can also click the Call me™ link, https://callme.viavid.com/viavid/?callme=true&passcode=13738729&h=true&info=company&r=true&B=6, for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start time. To participate in the webcast a link is available at https://viavid.webcasts.com/starthere.jsp?ei=1614938&tp_key=5a35eadcb6 and also at www.lipocine.com. The webcast will be available for replay for 180 days.

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