Slide 1: Efficacy & Pharmacokinetics of LPCN 1021, Novel Oral TRT in Obese & Non-Obese Hypogonadal Men
Efficacy & Pharmacokinetics of LPCN 1021, Novel Oral TRT ─ Obese & Non - Obese Hypogonadal Men Exhibit 99.1
Slide 2: Disclosures
Adrian Dobs • Research funding (Clinical researcher): Clarus, Endo; Honoraria (Advisory group): AbbVie , Endo, Lipocine , Inc. Anthony DelConte • Consulting fees: Lipocine, Inc. Martin Miner • Research funding (Clinical researcher): Forest, NERI; Consulting fees: AbbVie, Lipocine , Inc., Repro
Slide 3: Introduction - LPCN 1021
Introduction - LPCN 1021 3 LPCN 1021 is a novel oral testosterone undecanoate formulation that may avoid some of the undesirable attributes of non - oral testosterone formulations • Utilizes a novel lipid based oral delivery technology allowing twice - daily dosing – Improved solubilization – High
Slide 4: Key Inclusion Criteria
Males 18 - 80 years of age with documented onset of hypogonadism prior to age 65 Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired ) Serum T <300 ng/dL based on 2 blood samples, taken approximately same time of day on
Slide 5: Key Exclusion Criteria
Abnormal prostate exam (I - PSS score >19 points) Body mass index (BMI) ≥38 kg/m 2 Clinically significant abnormal laboratory value Concurrent medications that could affect PK measurements or patient health Partner who is concurrently pregnant or planning to become pregnant Key Exclusion C
Slide 6: SOAR (Study of Androgen Replacement) - Study Design
SOAR (Study of Androgen Replacement) - Study Design 6 Screening N=315 0 Week 3/4 Week 7/8 Randomization LPCN 1021 225 mg TU BID with meal (n=210 ) Active control: Androgel ® 1.62% (n=105 ) PK/Dose Titration PK/Dose Titration PK/Efficacy Assessment* Safety Assessment Week 13 Week 52 Safety Extension
Slide 7: SOAR: Patient Disposition & Baseline Demographics
SOAR: Patient Disposition & Baseline Demographics 7 210 subjects randomized in LPCN 1021 arm Status Non - obese [BMI < 30 kg/m 2 ], N = 92 Obese [BMI ≥ 30 kg/m 2 ], N = 118 Full Analysis Set* (%) 89 % of Randomized 94 % of Randomized Mean age, yrs (SD) 52.9 (11.0) 52.5 (9.7) Race, (%) African Americ
Slide 8: Efficacy Analysis after 13 Weeks
SOAR: LPCN 1021 Efficacy Analysis after 13 Weeks 8 89.0 86.4 0 10 20 30 40 50 60 70 80 90 100 110 Subjects (%) T Eugonadal Range Obese Efficacy Line LPCN 1021 is efficacious in obese and non - obese hypogonadal subjects and efficacy is comparable Non - obese 95% CI
Slide 9: Dose Distribution after 13 weeks
0 10 20 30 40 50 60 70 Non-obese Obese % of Subjects 150mg 225mg 300mg SOAR: LPCN 1021 Dose Distribution after 13 weeks 9 Majority of the hypogonadal subjects with final dose of 225mg BID (which was also the starting dose) following administration of LPCN 1021 for both the non - obese and obese popu
Slide 10: Serum Testosterone Levels Pre and Post Titration in Non-Obese Hypogonadal Subjects
0 200 400 600 800 1000 1200 0 5 10 15 20 25 30 Serum Testosterone ( ng /dl) Time (h) subjects needing down titration subjects needing no titration subjects needing up titration SOAR: LPCN 1021 Serum Testosterone Levels P re and Post Titration in Non - Obese Hypogonadal Subjects 10 Titration converge
Slide 11: Serum Testosterone Levels Pre- and Post-Titration in Obese Hypogonadal Subjects
0 200 400 600 800 1000 1200 0 5 10 15 20 25 Serum Testosterone ( ng /dl) Time (h) Subjects needing down titration Subjects needing no titration Subjects needing up titration 0 200 400 600 800 1000 1200 0 5 10 15 20 25 Serum Testosterone ( ng /dl) Time (h) Down titrated Same as starting dose Up titra
Slide 12: Serum Testosterone after 13 weeks
0 100 200 300 400 500 600 700 800 0 5 10 15 20 25 30 Serum Testosterone ( ng /dl) Time (h) Obese Non Obese Mean serum t estosterone l evels are comparable between non - obese and obese hypogonadal men following LPCN 1021 administration (N = 192) SOAR: LPCN 1021 Serum Testosterone after 13 weeks 12
Slide 13: Testosterone PK after 13 weeks
SOAR: LPCN 1021 Testosterone PK after 13 weeks 13 Comparable T C ave, 24h and T C max observed between non - obese and obese hypogonadal subjects following administration of LPCN 1021 (Full Analysis Set; N = 192) 498 1288 464 1222 0 200 400 600 800 1000 1200 1400 1600 1800 2000 Mean T Cave, 24h (ng/
Slide 14: Serious Adverse Events
As of March 31, 2015 • No drug - related SAEs • No cardiac - related SAEs Serious Adverse Events 14
Slide 15: Conclusions
LPCN 1021 is an orally administered TRT product with acceptable serum T levels for both non - obese and obese hypogonadal men. Obese hypogonadal men may require a marginally higher mean dose (about 10%) compared to non - obese men LPCN 1021 is an option for men requiring testosterone therapy a
Slide 16: Forward Looking Statements
Forward Looking Statements 16 This presentation contains and our discussions during this conference may include forward - looking statements about Lipocine Inc. (the “Company”). These forward - looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Re