Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Technical Presentation (December 2020)
6 slides from Palatin Technologies's technical presentation, December 2020
Slide 1: PL9643 for Dry Eye Disease: Summary of Phase 2 Clinical Results
1 PL9643 FOR DRY EYE DISEASE SUMMARY OF PHASE 2 CLINICAL RESULTS NEXT STEPS EXECUTIVE SUMMARY December 2020
Slide 2: Overview of the PL9643 Compound
Overview of the PL9643 Compound 2 ▪ Palatin’s proven R&D team’s primary scientific focus is the melanocortin system (MS) that involves the regulation of energy balance including food intake, sexual function and resolution of inflammatory responses. ▪ The melanocortin system mediates a diverse array
Slide 3: Design of the PL9643-201 Phase 2 Study
Design of the PL9643-201 Phase 2 Study 3 ▪ Multi-center, Randomized, Double–Masked and Placebo–Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects with Dry Eye. ▪ The study enrolled 160 participants randomized in a 1:1 ratio into two arms
Slide 4: PL9643-201: Statistically Significant Clinical Results in Moderate-Severe Patients
PL9643-201: Statistically Significant Clinical Results in Moderate-Severe Patients 4 ▪ In the sub-population of moderate to severe patients (N=61), PL9643 achieved: o Statistical significance (P value <0.05 vs. vehicle) at week 2 and week 12 for multiple signs: inferior (primary sign endpoint), supe
Slide 5: PL9643: Commercial Opportunity in Dry Eye Disease
PL9643: Commercial Opportunity in Dry Eye Disease 5 ▪ DED is estimated to affect over 20 million people in the United States o Majority of people suffering from DED are in the moderate to severe category (>75%) o In most cases have had this condition for a prolonged period ▪ Annual sales in the Unit
Slide 6: PL9643 Dry Eye Disease Development – Next Steps
PL9643 Dry Eye Disease Development – Next Steps 6 Submit Phase 2 Study EOP2 FDA Meeting Complete Non-clinical to FDA Activities 1Q 2021 2Q 2021 2Q 2021 Initiate Phase 2/3 Study Initiate Phase 3 Study NDA to FDA Submission Mid 2021 1H 2022 1H 2023 Data 1Q 2022
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