Lipocine Inc. · NASDAQ:LPCN
Lipocine — Corporate Update (May 2023)
14 slides from Lipocine's corporate update, May 16, 2023
Slide 1: LPCN 1154 Oral Neuroactive Steroid for Depression Disorders: Topline Results
LPCN 1154 Oral Neuroactive Steroid for Depression Disorders Topline Results PK Bridge Clinical Study Conference Call May 16, 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, the anticipated u
Slide 3: LPCN 1154 Mechanism of Action
LPCN 1154 Strong Pharmacological Rationale GABA Receptor Substrates Binding Mechanism of Action Brexanolone is a positive Allosteric Modulator (PAM) of the GABAA receptor Hormonal changes leading to GABA dysfunction are common in depression and pregnancy https://opentext.wsu.edu/psych105nusbaum/chap
Slide 4: Oral Enablement of Brexanolone
Validated Proprietary Lip’ral Technology Platform Oral Enablement of Brexanolone Achieved Relevant Systemic Levels in Phase 1 Study Observed PK Profile Post Oral Administration Mean Plasma Concentration of 70 60 Brexanolone (ng/mL) 50 40 30 20 10 0 0 4 8 12 16 20 24 Time (hr) Study in post-menopausa
Slide 5: LPCN 1154 for Depression Disorders
LPCN 1154 for Depression Disorders New Treatment Paradigm for Depression Significant Unmet Needs in Depression Disorders: •Per NIMH, in 2020, an estimated 21.0 million (8.4%) adults in the US had at least one major depressive episode.1 •TRD: Prevalence ~2.8 million in US 2 •The prevalence of comorbi
Slide 6: Postpartum Depression (PPD) Rapid Relief Matters
Postpartum Depression (PPD) A Major Depressive Disorder Within Weeks of Childbirth • Estimated patients in the U.S. with PPD: ~500K annually1 • The prevalence of adolescent-onset PPD is two-folds higher than adult-onset PPD2 • Suicide/suicide ideation, a significant concern: Suicide is a leading cau
Slide 7: Limitations of Current Pharmacological Treatment Modality for PPD
Limitations of Current Pharmacological Treatment Modality for PPD PPD – A Substantial Opportunity SSRIs/SNRIs Injectable Brexanolone (Not approved for PPD indication, off label use) (The only FDA approved treatment) Slow onset of antidepressant action – may take 4-6 weeks1 Logistics of 60-hour IV in
Slide 8: LPCN 1154: A Potential Preferred Option for Rapid Relief in PPD
LPCN 1154: A Potential Preferred Option for Rapid Relief in PPD The Days After Childbirth are a Critical Time Period for the Care of Both Mother and Newborn Product Candidate Product Candidate Attributes Attributes • Monotherapy or add-on therapy for patients (including adolescents) with unresolved
Slide 9: LPCN 1154: Pilot PK Bridge Study
LPCN 1154: Pilot PK Bridge Study Rationale and Clinical Design • FDA agrees with Lipocine's proposal to establish efficacy through a pharmacokinetic (PK) bridge to IV brexanolone • An open-label, randomized, three-period, 3-arm partial crossover study to compare the PK of oral LPCN 1154 (brexanolone
Slide 10: IV Brexanolone Demonstrated Efficacy with Two Dosing Regimens
IV Brexanolone Demonstrated Efficacy with Two Dosing Regimens • Maximum infusion rate of 90 µg/kg/hr and 60 µg/kg/hr IV Brexanolone (µg/kg/hr) 90 60 30 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 Hour Source: Zulresso: Highlights of Prescribing Information. https://www.accessdata.fda.gov/drugsatf
Slide 11: Pharmacokinetic Results
Pharmacokinetic Results Dosing Regimen Identified for Confirmatory PK Study Ratios (%) of geometric mean LPCN 1154 regimens vs IV brexanolone regimens PK DR 1 vs DR 1 vs DR 2 vs DR 2 vs Parameter IV 60 µg* IV 90 µg IV 60 µg* IV 90 µg AUC∞ 98% 77% 106% 83% Cmax 114% 68% 134% 79% • DR 1 resulted in co
Slide 12: LPCN 1154 Was Well-Tolerated
LPCN 1154 Was Well-Tolerated Consistent with Prior LPCN 1154 Clinical Experience All AEs were mild or moderate in severity AEs were similar across trial arms Majority (63%) AEs were venipuncture site pain (PK draws) or venipuncture site reactions (IV infusions) No Serious Adverse Events were
Slide 13: Streamlined Pathway to NDA Submission
LPCN 1154 Streamlined Pathway to NDA Submission Initiate 2H 2023 Phase 1 Pilot PK Bridge Study PK PK Pivotal Pivotal StudyStudy Successful single dose study completed Positive Topline Results Required for NDA Confirmatory filing trial to establish Established feasibility of oral administration effic
Slide 14: LPCN 1154: A New Paradigm in Oral Treatment for Depression
LPCN 1154: A New Paradigm in Oral Treatment for Depression Conclusions Differentiated product attributes address unmet needs Oral , rapid relief, short treatment duration, high remission rate* Brexanolone is an approved neuroactive steroid for depression with validated unique mechanism of acti