Slide 1: TLANDO, Oral Testosterone Replacement Therapy without Dose Titration Requirement in Hypogonadal Men
TLANDO™, Oral Testosterone Replacement Therapy without Dose Titration Requirement in Hypogonadal Men Anthony DelConte, MD 1,2 ; Nachiappan Chidambaram, PhD 1 ; Kongnara Papangkorn, PhD 1 ; Benjamin J. Bruno, PharmD, PhD 1 ; Kilyoung Kim, PhD 1 ; Mahesh V. Patel, PhD 1 1 Lipocine Inc., Salt Lake City
Slide 2: Background
Background • Most marketed testosterone replacement therapy (TRT) products require multiple titration visits to achieve desired eugonadal testosterone (T) levels • Typical titration for TRT takes 3 - 6 months to reach efficacious dose for majority of patients 2
Slide 3: TLANDO Unique Delivery System Enables Effective Oral TRT Performance
TLANDO* Unique Delivery System Enables Effective Oral TRT Performance □ Not known to produce adverse events that are associated with 17 - methylated testosterone □ Consistent intra & inter - day T restoration* * LPCN 1021 - 14 - 001 Study * LPCN 1021 - 13 - 001 Study: 225mg BID 3 □ Not prone to lowe
Slide 4: Objective and Study Designs
Objective and Study Designs □ The objective was to assess whether TLANDO, to - be - marketed oral TRT option without need for any dose adjustment, can safely and effectively restore testosterone levels in hypogonadal men 4 □ Two P3 studies with TLANDO without dose titration were performed ▪ Study 16
Slide 5: TLANDO Efficacy & Tolerability
TLANDO Efficacy & Tolerability Daily dose 450mg without requiring dose adjustment □ Efficacy* ▪ 81% (95% CI: 72 – 88%) ▪ Mean T Cavg : 478 ng/dL □ Adverse Events ▪ No death, no drug - related SAEs ▪ Mild to moderate Adverse Reaction ≥ 2% (STUDY 18 - 001) Overall (N=138) n (%) Hematocrit increased/Po
Slide 6: Summary & Conclusions
Summary & Conclusions □ Safety and efficacy of TLANDO™ (Oral Testosterone Undecanoate) was confirmed □ TLANDO™ is a novel oral TRT option without requiring dose titration □ Start of therapy with the effective dose without delay □ Devoid of accidental T transference and pulmonary oil micro - embolism