PF-04360365

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Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Pfizer, Inc.|Last Updated: Apr 19, 2024

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker

Total Trials7

Total Enrollment331

FDA Designations

No designations recorded

Clinical Trials (7)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT00945672	A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease	PHASE2	COMPLETED	36	—	—	Aug 6, 2009	Jun 1, 2011	Apr 19, 2024	4	Sweden
NCT00722046	Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease	PHASE2	COMPLETED	198	—	—	Dec 5, 2008	Aug 16, 2011	Nov 7, 2022	42	United States, Australia +4
NCT01125631	Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease	PHASE1	COMPLETED	8	—	—	May 1, 2010	Aug 1, 2011	Aug 12, 2011	4	Japan
NCT01005862	Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers	PHASE1	COMPLETED	17	—	—	Mar 1, 2010	Sep 1, 2012	Sep 26, 2012	3	United States, Sweden
NCT00733642	Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease	PHASE1	COMPLETED	15	—	—	Aug 1, 2008	Jul 1, 2009	Jul 28, 2009	3	United States
NCT00607308	A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease	PHASE1	COMPLETED	20	—	—	Feb 1, 2008	Oct 1, 2010	Dec 7, 2010	9	Japan
NCT00455000	A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease	PHASE1	COMPLETED	37	—	—	Mar 1, 2007	Sep 1, 2009	Oct 14, 2009	12	Australia, Canada +2

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Study Endpoints

Primary Endpoints

Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Day 1 up to 6 months after last dose of study medication (up to 18 months)

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

Baseline up to Month 18

Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.

Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

Baseline up to Month 18

Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI.

Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

Baseline, Month 13

Quantitative amyloid imaging was performed using PET technique using \[11C\] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.

Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

0 hour on Day 0 (Day prior to dosing)