Abstract Details

Title Pharmacokinetics and Safety of Lu AG09222, an Anti-PACAP Monoclonal Antibody in Development for Migraine Prevention

Topic Headache

Presentation(s) P10 - Poster Session 10 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-015

Objective To investigate the pharmacokinetics (PK) and safety of Lu AG09222 using data from three phase 1 clinical trials.

Background Lu AG09222 is a humanised monoclonal antibody targeting pituitary adenylate cyclase-activating polypeptide (PACAP) that is in development for migraine prevention.

Design/Methods Data were included from a (1) first-in-human single ascending dose trial in healthy participants, including a cohort with co-administered sumatriptan (Lu AG09222 n=68; placebo n=28); (2) single-dose trial in healthy Caucasian, Chinese, and Japanese participants (Lu AG09222 n=40; placebo n=12); and (3) multiple-dose trial in participants with symptomatic allergic rhinitis (Lu AG09222 n=20; placebo n=10). Assessments included intravenous (IV) doses ranging from 1 mg to 750 mg and subcutaneous (SC) doses of 100 mg and 600 mg.

Results Overall, 128 and 50 participants received Lu AG09222 and placebo, respectively. Half-life was ~15 days (IV) and ~15–17 days (SC). Bioavailability after SC administration was ~80%. Maximum serum concentration and area under the curve increased in a dose-proportionate manner in participants receiving single IV doses from 1 mg to 750 mg. After multiple SC doses, exposure increased proportionally between 100 mg and 600 mg. There were no PK differences by sex, and PK was comparable in Caucasian, Japanese, and Chinese cohorts. Co-administration with sumatriptan did not result in PK interactions. Most treatment emergent adverse events (TEAEs) were mild; the most common TEAEs were injection site reactions (SC) and headache (both IV and SC). One serious AE, perniosis of moderate severity, occurred in a participant 112 days after receiving a single IV dose of 750 mg Lu AG09222 co-administered with sumatriptan.

Conclusions Lu AG09222 exhibited a consistent PK profile across dosing regimens, route of administration and race/ethnicity. Across these trials, no safety concerns were identified, and Lu AG09222 was generally well-tolerated.

Authors/Disclosures
Bjoern Sperling (H Lundbeck A/S) PRESENTER	Bjoern Sperling has received personal compensation for serving as an employee of Lundbeck . Bjoern Sperling has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Rehaler . Bjoern Sperling has or had stock in Lundbeck .
Messoud Ashina, MD, PhD (Dept. of Neurology)	Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Incyte. The institution of Dr. Ashina has received research support from The Lundbeck Foundation. The institution of Dr. Ashina has received research support from Novo Nordisk Foundation . The institution of Dr. Ashina has received research support from Danish National Research Foundation . Dr. Ashina has received publishing royalties from a publication relating to health care.
Johan Areberg, PhD	Mr. Areberg has stock in H. Lundbeck A/S. Mr. Areberg has received intellectual property interests from a discovery or technology relating to health care.
Peter H. Eriksen	Mr. Eriksen has received personal compensation for serving as an employee of Lundbeck. Mr. Eriksen has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Atrium. Mr. Eriksen has stock in Lundbeck.
Amaal J. Starling, MD, FAAN (Mayo Clinic)	Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Starling has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Miller Medical. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Salvia. Dr. Starling has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Woodberry Associates .
Stine Larsen, PhD	The institution of Ms. Larsen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Lundbeck. Ms. Larsen has stock in Lundbeck.
Jette Buch Oestergaard, PhD	Dr. Oestergaard has received personal compensation for serving as an employee of H. Lundbeck A/S.
Ole Lemming, MS	Mr. Lemming has received personal compensation for serving as an employee of Lundbeck.
Thomas Krogh-Meibom, PhD	Dr. Krogh-Meibom has nothing to disclose.
Ioana F. Florea, MD	Mrs. Florea has received personal compensation for serving as an employee of H Lundbeck A/S. Mrs. Florea has stock in H Lundbeck A/S.
Charlotte Granhall, PhD	Miss Granhall has received personal compensation for serving as an employee of Lundbeck A/S.

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