9M 2023 Financial Performance
9M 2023: APPENDIX
Vyepti: Phase III study for treatment of cluster headache, a
crippling pain with few effective medications currently available
Cluster headache affects
approximately one in 1,000
people across the world
These are severe attacks of one-sided
pain in the head, much stronger than a
normal headache
Cluster Headaches are also known as
"Suicide Headaches" due to the
intensity of pain leading to frequent
suicide ideation
Duration
Frequency
15-180 min
1-8 times a day
20-40 yrs.
1:1,000
Age of onset
Prevalence
Episodic/chronic ratio
6:1
Male/female ratio
4.3:1
CHRONICLE¹) phase III study to
evaluate safety of eptinezumab in
chronic Cluster Headache (CCH)
Eptinezumab intravenous in
~125 patients with CCH
• Primary endpoint: Number of
participants with adverse events
•
Results show that patients with chronic
cluster headache receiving open-label
treatment with eptinezumab report
reductions in attack frequency, pain
severity, and improvement on patient
global impression
ALLEVIATE²) phase III study to
evaluate eptinezumab in episodic
Cluster Headache (eCH)
⚫ Eptinezumab intravenous in
~300 patients with eCH
.
.
Primary endpoint: Change from
baseline in number of weekly attacks
(Weeks 1-2)
• First patient, first visit (FPFV)
commenced in December 2020
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21
1) ClinicalTrials.gov Identifier: NCT05064397 2) NCT04688775
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