Chelsea Therapeutics International Ltd
Chelsea Therapeutics International — Technical Presentation (December 2012)
21 slides from Chelsea Therapeutics International's technical presentation, Dec 5, 2012
Slide 1: Northera (droxidopa) Study 306B Preliminary Results
© 2004 - 2012 Chelsea Therapeutics, Inc. Northera ™ ( droxidopa ) Study 306B Preliminary Results 4 December 2012
Slide 2: Forward-Looking Statements
NASDAQ: CHTP 2 Forward - Looking Statements This presentation is being provided for informational and discussion purposes . This presentation is not intended to provide and should not be relied upon as investment advice or an opinion regarding the appropriateness or suitability of any investment . N
Slide 3: Study 306B: a Phase III Trial of Northera in NOH Associated with PD
Study 306B: a Phase III Trial Evaluating the Safety and Efficacy of Northera ™ ( droxidopa ) for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension (NOH) Associated with Parkinson’s Disease (PD) NASDAQ: CHTP 3
Slide 4: Northera Study 306B Highlights
Northera Study 306B Highlights • Primary Endpoint - Improvement on Dizziness/Lightheadedness at Week 1 • Statistically significant difference (p=0.018) • 1.0 unit improvement vs. placebo consistent with previous studies • Standing Systolic Blood Pressure • 5.6 mmHg increase vs. placebo at Week 1 (p=
Slide 5: Explanation of 306A & B
Explanation of 306A & B • Study 306 is a US - based, Phase III, placebo - controlled study of Northera ( droxidopa ) in Parkinson’s Disease patients with Symptomatic Neurogenic Orthostatic Hypotension • Following an interim analysis, Study 306 was divided into two parts; 306A and 306B, differing onl
Slide 6: Study Design: Northera in PD patients with NOH
NASDAQ: CHTP 6 306 Study Design : Northera in PD patients with NOH Visit 2 Northera , TID Placebo, TID Visits 3a, 3b, 3c, etc. Visit 4 Visit 5 Visit 6 Visit 7 600 mg 500 mg 400 mg 300 mg 200 mg 100 mg 600 mg 500 mg 400 mg 300 mg 200 mg 100 mg Week 1 Week 2 Week 4 Week 8 Randomization / Baseline Doub
Slide 7: Study 306B Primary Endpoint: OHSA Item 1 at Week 1
Northera Placebo 0.0 0.5 1.0 1.5 2.0 2.5 * *p<0.05 Improvement in dizziness score Study 306B Primary Endpoint: OHSA Item 1 at Week 1 Mean ± SEM (n=78) (n=69) NASDAQ: CHTP 7
Slide 8: Study 306B: Responder Analysis of Primary Endpoint
1 unit 2 unit 3 unit 4 unit 25% 50% 0 10 20 30 40 50 60 70 80 Northera Placebo * p<0.05 ** p<0.01 * * * * ** Improvement in dizziness/lightheadedness % of patients Study 306B: Responder Analysis of Primary Endpoint (n=69) (n=78) NASDAQ: CHTP 8
Slide 9: Study 306B: OHSA Item 1 at All Study Visits
Week 1 Week 2 Week 4 Week 8 0 1 2 3 Northera Placebo * p<0.05 * Time of Measurement Improvement in dizziness score Study 306B: OHSA Item 1 at All Study Visits Mean ± SEM NASDAQ: CHTP 9
Slide 10: Study 306B: Change in Standing Systolic Blood Pressure
BL -5 0 5 10 Northera Placebo 1 2 3 4 5 6 7 8 * p<0.05 * Weeks of Stable Dose in Standing SBP (mmHg) Study 306B: Change in Standing Systolic Blood Pressure Mean ± SEM NASDAQ: CHTP 10
Slide 11: Study 306B: Rate of Falls
Northera Placebo 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Rate of falls (per patient-week) Study 306B: Rate of Falls Mean ± SEM (n=78) (n=69) p=NS NASDAQ: CHTP 11
Slide 12: Study 306B: Rate of Falls - Sensitivity Analyses
-2 pts/group - 5 pts/group -10pts/group 0.0 0.1 0.2 0.3 0.4 0.5 Northera Placebo Rate of falls (per patient-week) Study 306B: Rate of Falls - Sensitivity Analyses Mean ± SEM NASDAQ: CHTP 12
Slide 13: Study 306B: Fall-Related Injuries
Study 306B: Fall - Related Injuries NORTHERA (N=89) PLACEBO (N=82) # of pts (%), # of events # of pts (%), # of events AE Preferred Term 15 ( 16.9%), 24 21 ( 25.6%), 35 Contusion 3 ( 3.4%), 4 10 ( 12.2%), 12 Excoriation 5 ( 5.6%), 5 7 ( 8.5%), 7 Skin laceration 3 ( 3.4%), 6 7 ( 8.5%), 7 Laceration 2
Slide 14: Study 306B: Safety
Study 306B: Safety NORTHERA (N=89) PLACEBO (N=82) # of pts (%) # of events # of pts (%) # of events Treatment Emergent AEs 73 (82.0%) 225 65 (79.3%) 190 SAEs 5 (5.6%) 9 4 (4.9%) 5 AEs Leading to Discontinuation 11 (12.4%) 11 5 (6.1%) 5 Most Common* AEs Headache 12 (13.5%) 16 6 (7.3%) 6 Dizziness 9 (
Slide 15: Study 306B: Incidence of Supine Hypertension
Study 306B: Incidence of Supine Hypertension NORTHERA (N=89) PLACEBO (N=82) N (%) N (%) SBP > 200 mmHg 3 (3.3%) 1 (1.2%) SBP > 180 mmHg 7 (7.3%) 4 (4.7%) SBP > 160 mmHg 28 (23.9%) 19 (19.0%) Note: Incidence of supine hypertension defined by 3 consecutive blood pressure measurements during Orthostati
Slide 16: Study 306: Meta Analysis of OHSA Item 1
Week 1 Week 2 Week 4 Week 8 0 1 2 3 Northera Placebo ** * p<0.05 **p<0.01 Time of Measurement Improvement in dizziness score Study 306: Meta Analysis of OHSA Item 1 Mean ± SEM NASDAQ: CHTP 16
Slide 17: Study 306: Meta Analysis of Rate of Falls
Study 306: Meta Analysis of Rate of Falls Mean ± SEM 306 Meta Analysis Rate of Falls Northera Placebo 0 1 2 3 Rate of falls (per patient-week) 306 Meta Analysis Sensitivity Analyses Rate of Falls -2 pts/group - 5 pts/group -10 pts/group 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 Northera Placebo Rate of falls
Slide 18: NOH Studies with Northera
* Adjusted mean and confidence interval NOH Studies with Northera 18
Slide 19: Summary Study 306B Results
Summary Study 306B Results • Primary Endpoint: Improvement on Dizziness/ Lightheadedness • Secondary Endpoints: Standing Systolic Blood Pressure, Falls and Falls - related Injuries • Safety and Tolerability Next Steps • Further Analyses of 306B • Extensive Database of 650 NOH patients • Inform Our N
Slide 20: Questions for Dr. Hauser
Questions for Dr. Hauser • What are your thoughts on Study 306B and what the efficacy results tell us? • Can you speak to what the data informs you on the tolerability of Northera ? • In your opinion, how could a therapy like Northera help your patients with NOH? NASDAQ: CHTP 20
Slide 21: Northera (droxidopa) Study 306B Preliminary Results
© 2004 - 2012 Chelsea Therapeutics, Inc. Northera ™ ( droxidopa ) Study 306B Preliminary Results 4 December 2012 21
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