Slide 1: Intramuscular Peramivir Phase II Preliminary Results Conference Call
Intramuscular Peramivir Phase II Preliminary Results Conference call September 19, 2007
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains projections or other forward looking statements regarding future events or the future financial performance of BioCryst Pharmaceuticals, Inc., including predictions of timing and potential success of clinical trials by us and our collaborators, a
Slide 3: Agenda
Phase II Study Design Preliminary Results Next Steps Agenda
Slide 4: Summary of Peramivir Phase II Study
Summary of Peramivir Phase II Study Designed to test if peramivir could reduce duration of symptoms when administered acutely in high doses intramuscularly Randomized, double-blind, placebo-controlled trial of 344 subjects (outpatient) with uncomplicated acute influenza Subjects identified through p
Slide 5: Summary of Findings
In the intent to treat infected study population the primary endpoint of time to alleviation of symptoms was missed. Both doses demonstrated an improvement over placebo, but this improvement was not statistically significant: 22.9 hour reduction - 150 mg dose vs. placebo (p=0.284) 21.1 hour reductio
Slide 6: Intramuscular injections into the buttocks: Are they truly intramuscular?
"Intramuscular injections into the buttocks: Are they truly intramuscular?" Radiologic study of i.m. injections into the buttocks with a 30mm (1 1/4 ") needle 32% of injections reached muscle tissue and the majority of injections were subcutaneous By gender 56% of males and 8% of females had i.m. in
Slide 7: For i.m. Injection, Technique and Needle Length Matter
For i.m. Injection, Technique and Needle Length Matter Needle length matters for drugs injected by the i.m. route of administration Body habitus and weight influence choice of needle length Extensive literature supports importance of this issue for adequate i.m. drug delivery References: Journal of
Slide 8: Unique Pharmacokinetic Profile of Peramivir
Unique Pharmacokinetic Profile of Peramivir Intramuscular Administration Produces PK Profile That Parallels Intravenous Dosing J. Kilpatrick, Pharmacokinetics and Safety of Peramivir by Intramuscular Administration, Options for the Control of Influenza VI, Toronto, 2007
Slide 9: Day 3 Creatine Kinase Increase Correlates with Adequate i.m. Injection
300mg Peramivir (2 injections- 4mL) 150mg Peramivir (1 injection- 2mL) Phase I: Phase II: All subjects received 2 injections- 4mL Overall lower CK rises suggest 1 inch needle produced inadequate i.m. injection in majority of subjects in Phase II Sub-group of subjects receiving adequate i.m. injectio
Slide 10: Symptom Alleviation Increases with Rise in Creatine Kinase at Day 3
The Degree of Symptom Alleviation in Subjects Treated with Peramivir Increases with Increasing Rise in Creatine Kinase at Day 3 ^100.4 ^65.8 163.2 82 ^ 90 U/L ^100.1 ^65.8 163.2 83 ^ 80 U/L ^100.1 ^62.0 163.2 85 ^ 70 U/L ^64.8 ^54.8 152.2 95 ^ 60 U/L ^64.8 ^44.6 152.2 101 ^ 50 U/L ^58.3 ^48.2 162.3
Slide 11: Adequate i.m. Injection Showed Up to 2.6 Days of Improvement over Placebo
Adequate Injection Population (n = 101) Median time to alleviation of symptoms (hrs) (95% Confidence Interval) Improvement over placebo (hrs) n = 102 115.9 (77.8-136.6) 21.1 p=0.152 n = 104 114.1 (95.2-145.5) 22.9 p=0.284 n = 107 137.0 (115.9-165.8) - - Total Intent-to-Treat-Infected* Population (n
Slide 12: Peramivir Was Well Tolerated at Both Doses
115 3 (3%) 5 (4%) 0 (0%) 0 (0%) 113 3 (3%) 4 (4%) 1 (1%) 2 (2%) 114 3 (3%) 3 (3%) 4 (4%) 1 (1%) Total Safety Population* (n = 342) No. of subjects Diarrhea Nausea Vasovagal reaction Vomiting 31 0 (0%) 1 (2%) 0 (0%) 0 (0%) 33 1 (3%) 0 ( 0%) 1 ( 3%) 0 ( 0%) 41 1 ( 2%) 1 ( 2%) 0 ( 0%) 0 ( 0%) Adequate
Slide 13: Achievement of Goals - Phase II
Provide preliminary efficacy data to establish the proof of concept for a single i.m. injection of peramivir in uncomplicated influenza and confirm dose selection for the pivotal phase III program Establish the safety and tolerability profile of single doses of i.m. peramivir to support exposure of
Slide 14: Next Steps
Complete analysis of Phase II data Full package of safety and efficacy Quantitative change in viral shedding Meet with FDA to review data Start the Phase III studies - be ready to enroll first subject by year-end Detailed PK study focused on: Needle length Subject BMI Pharmacokinetics Next Steps
Slide 15: Intramuscular Peramivir Phase II Preliminary Results Conference Call
Intramuscular Peramivir Phase II Preliminary Results Conference call September 19, 2007