Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-04950615 (RN316)
PF-04950615 · 4 trials · 6 indications
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance (CL/F) is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Volume of distribution (Vz) is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is determined when overall intake of drug is in dynamic equilibrium with its elimination.
t1/2 is the time measured for the plasma concentration of drug to decrease by one half.
Bioavailability is defined as the rate and extent to which the active moiety administered drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was estimated by comparing log-transformed dose-normalized AUClast for subcutaneous to intravenous dose.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding.
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 78 that were absent before treatment or that worsened relative to pretreatment state.
An AE was any untoward medical occurrence in a participant who received study drug. AE was assessed according to common terminology criteria for adverse events (CTCAE) version 4.0 severity grades- Grade 1: mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2: moderate (minimal, local or non invasive intervention indicated); Grade 3: severe (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling); Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to AE.
Criteria: Haemoglobin(Hgb), hematocrit, RBC: \<0.8\*lower limit of normal(LLN),mean corpuscular volume, mean corpuscular Hgb concentration \<0.9\*LLN or\>1.1\*upper limit of normal(ULN), platelet\<0.5\*LLN or\>1.75\*ULN, WBC\<0.6\*LLN or\>1.5\*ULN, lymphocyte, neutrophil\<0.8\*LLN or\>1.2\*ULN, basophil, eosinophil, monocyte\>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, lactate dehydrogenase\>3.0\*ULN,total protein,albumin\<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine\>1.3\*ULN,uric acid\>1.2\*ULN;sodium\<0.95\*LLNor\>1.05\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN or\>1.1\*ULN; glucose\<0.6\*LLN or \>1.5\*ULN, urine specific gravity\<1.003 or\>1.030,urine pH\<4.5or\>8,urine glucose, ketones, urine protein,urine blood/Hgb,urobilinogen,bilirubin,nitrite, leukocyte esterase\>=1; urine RBC,WBC\>=20,urine epithelial cells\>=6,urine granular casts,hyaline casts\>1,urine bacteria\>20,partial thromboplastin time,prothrombin:\>1.1\*ULN.
Criteria for clinically relevant vital signs: supine and standing systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg); supine and standing diastolic blood pressure (DBP): \<50 mmHg. Maximum increase from baseline (IFB) or decrease from baseline (DFB) in supine and standing SBP: greater than or equal to (\>=) 30 mmHg and maximum IFB or DFB in supine and standing DBP: \>=20 mmHg. Supine pulse rate: \<40 and greater than (\>) 120 beats per minute (bpm); standing pulse rate: \<40 and \>140 bpm.
Criteria for clinically relevant ECG parameters: PR interval: maximum IFB of \>=25 percent or 50 percent; QRS complex: maximum IFB of \>=25 or 50 percent; QTcF interval (Fridericia's Correction): maximum IFB of \>=30 millisecond (msec) to \<60 msec and maximum IFB of \>=60 msec.
The number of participants with at least one positive ADA were summarized for each treatment arm. Participants with positive antibody titer of \>4.32 milligram/milliliter (mg/mL) were considered as ADA positive.
| Arm | Type | Description |
|---|---|---|
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Treatment E | EXPERIMENTAL | - |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Group D | EXPERIMENTAL | - |
| A | PLACEBO_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Intravenous placebo monthly during treatment phase. |
| Statin | DRUG | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
| PF-04950615 (RN316) | BIOLOGICAL | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| Satin | DRUG | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
Inclusion Criteria: * On a stable daily dose of atorvastatin, rosuvastatin or simvastatin. * Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL Exclusion Criteria: * History of a cardiovascular or cerebrovas...
Top 12 of 15 competitors
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|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
PF-04950615 is an investigational monoclonal antibody being studied for hypercholesterolemia, a condition of elevated cholesterol. It was evaluated in patients with hypercholesterolemia and dyslipidemia, including those already taking maximum or high doses of statins. It is not an approved therapy.
PF-04950615 targets PCSK9, a protein involved in regulating cholesterol levels. By binding to PCSK9, the antibody is designed to affect cholesterol handling in the body. This mechanism underlies its development for lowering cholesterol in patients with hypercholesterolemia.
PF-04950615 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program evaluating the antibody in patients with hypercholesterolemia and dyslipidemia.
PF-04950615 is in Phase 2 development. It is an investigational monoclonal antibody and has not been approved for any indication. Four clinical trials have been completed, including two Phase 1 studies and two Phase 2 studies, with no active trials ongoing.
Four completed trials studied PF-04950615: NCT01435382 and NCT01243151 were Phase 1 studies, while NCT01350141 and NCT01342211 were Phase 2 studies in patients on statins. All were randomized, double-blind, and placebo-controlled, enrolling 256 participants total across the United States and Canada.
Yes, PF-04950615 is also known as RN316. The names PF-04950615 (RN316), PF-04950615 Dose A, and 200mg PF-04950615 (RN316) refer to the same Pfizer monoclonal antibody targeting PCSK9 for hypercholesterolemia.