recaticimab (SHR-1209) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. (PubMed, Eur J Drug Metab Pharmacokinet) - P1 | "A single subcutaneous injection of 450 mg recaticimab into the abdomen, upper-arm, or thigh was well-tolerated and presented similar PK and PD profiles, which supported the interchangeable use of the three injection sites for patients."

Journal • P1 data • PK/PD data • Dyslipidemia

Prospective, exploratory clinical study of Camrelizumab combined with Recaticimab for first-line maintenance in advanced NSCLC (ChiCTR) - P=N/A | N=37 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhengzhou University; First Affiliated Hospital of Zhengzhou University

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Long-term efficacy and safety of Recaticimab in patients with ASCVD or at high risk of ASCVD not achieving lipid targets (ChiCTR) - P4 | N=140 | Recruiting | Sponsor: Second Xiangya Hospital of CSU; Second Xiangya Hospital of CSU

New P4 trial • APOB

PISTIAS-2: PCSK9 Inhibitor with Statin Therapy for Asymptomatic Intracranial Atherosclerosis (clinicaltrials.gov) - P4 | N=300 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P4 trial • Atherosclerosis • Cardiovascular • Plasma Aβ40

Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Dyslipidemia • Metabolic Disorders

Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Beijing Chest Hospital, Capital Medical University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Mar 2027 | Trial primary completion date: Dec 2025 ➔ Aug 2026

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial. (PubMed, J Am Coll Cardiol) - "Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia."

Clinical • Journal • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Genetic Disorders • Metabolic Disorders • APOB

Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia: The Phase 3 REMAIN-1 Randomized Trial. (PubMed, J Am Coll Cardiol) - "Recaticimab monotherapy yielded significant LDL-C reductions and showed comparable safety vs placebo in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate ASCVD risk, even with an infrequent dosing interval up to Q12W."

Clinical • Journal • Monotherapy • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

A Step Forward for Long-Acting PCSK9 Inhibition: Improvements Without a Breakthrough. (PubMed, J Am Coll Cardiol) - No abstract available

Journal • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

Adebrelimab Plus Chemo and Recaticimab Perioperative Treatment for Resectable NSCLC (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Beijing Chest Hospital, Capital Medical University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PCSK9 MONOCLONAL ANTIBODY RECATICIMAB IN ADULT HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (REMAIN-3): A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY (ACC 2024) - P3 | "Pts were randomly allocated (2:1) to receive recaticimab or placebo (SC, 150 mg, Q4W) for 12 weeks, stratified by concomitant use of ezetimibe (yes vs. no) and LDL-C (≥ vs. <4.1 mmol/L). Recaticimab at 150 mg Q4W significantly lowered LDL-C compared with placebo, with an acceptable safety profile, providing a promising treatment option for HeFH pts."

Clinical • P3 data • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2023 American Heart Association Scientific Sessions. (PubMed, Curr Atheroscler Rep) - "Included studies assessed semaglutide and cardiovascular outcomes in overweight or obese patients without diabetes (SELECT); dapagliflozin in patients with acute myocardial infarction without diabetes (DAPA-MI); effects of dietary sodium on systolic blood pressure in middle-aged individuals (CARDIA-SSBP); long-term blood pressure control after hypertensive pregnancy with physician guided self-management (POP-HT); effect and safety of zilebesiran, an RNA interference therapy, for sustained blood pressure reduction (KARDIA-1); recaticimab add-on therapy in patients with non-familial hypercholesterolemia and mixed hyperlipidemia (REMAIN-2); efficacy and safety of lepodisiran an extended duration short-interfering RNA targeting lipoprotein(a); safety and pharmacodynamic effects of an investigational DNA base editing medicine that inactivates the PCSK9 gene and lowers LDL cholesterol (VERVE-101); automated referral to centralized pharmacy services for evidence-based statin..."

Journal • Review • Acute Coronary Syndrome • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Myocardial Infarction • Obesity • PCSK9

Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia (clinicaltrials.gov) - P3 | N=692 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dyslipidemia • Genetic Disorders • Metabolic Disorders

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2023 European Society of Cardiology Congress. (PubMed, Curr Atheroscler Rep) - "Safety and efficacy data of inclisiran, a PCSK9-interfering mRNA (PCSK9i) administered subcutaneously twice annually, were presented. Data on two new PCSK9is were presented, recaticimab, an oral drug, and lerodalcibep, a subcutaneous drug with a slightly different architecture than currently available PSCK9is. A phase 1 trial on muvalaplin, an oral lipoprotein (a) inhibitor, was presented...Long-term follow-up of patients enrolled in the CLEAR outcomes trial showed sustained and more significant ASCVD risk reduction with bempedoic acid in high-risk patients. The late-breaking clinical science at the 2023 congress of the ESC extends the known safety and efficacy data of a PCSK9i with the introduction of new drugs in this class. Using cumulative exposure to LDL-C rather than a single value will help clinicians tailor the LDL-C reduction strategy to individual risk and is an important step towards personalized medicine."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia

Recaticimab Add-On Therapy in Patients With Non-Familial Hypercholesterolaemia and Mixed Hyperlipidemia (REMAIN-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial (AHA 2023) - P3 | "Pts with LDL-C =2.6 mmol/L (or =1.8 mmol/L in pts with ASCVD) on stable moderate or high intensity statin (± cholesterol absorption inhibitors [ezetimibe] or fenofibrate) for =4 wks and fasting triglyceride =5.6 mol/L, were randomized (2:2:2:1:1:1) to receive recaticimab 150 mg Q4W, 300 mg Q8W or 450 mg Q12W or matching placebo injections for 48 wks. Over 48 weeks, rates of AEs were similar in the recaticimab and placebo groups (84.4% vs. 82.8%). Common AEs (frequency =5%) in pts receiving recaticimab were upper respiratory tract infection, hyperuricaemia, urinary tract infection, increased blood CPK, COVID-19 infection, increased ALT, and increased AST.Conclusion REMAIN-2 demonstrated the efficacy and long-term safety of add-on recaticimab, as an effective therapeutic option with an infrequent dosing interval, in pts with non-FH and mixed hyperlipidemia inadequately controlled on stable statin therapy."

Clinical • Late-breaking abstract • P3 data • Dyslipidemia • Familial Hypercholesterolemia • Infectious Disease • Nephrology • Novel Coronavirus Disease • Respiratory Diseases

REMAIN-1: A phase 3 study of recaticimab monotherapy in dyslipidaemia (ESC 2023) - No abstract available

Late-breaking abstract • Monotherapy • P3 data • Cardiovascular • Dyslipidemia

Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage (clinicaltrials.gov) - P3 | N=709 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Jan 2023 | Trial primary completion date: Jan 2022 ➔ Jun 2022

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders • APOA1 • APOB

SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research (clinicaltrials.gov) - P3 | N=144 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2022 ➔ Aug 2022 | Trial primary completion date: Apr 2022 ➔ Aug 2022

Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders

Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers (clinicaltrials.gov) - P1 | N=159 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Dec 2022 | Trial primary completion date: Sep 2022 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Metabolic Disorders

The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia (clinicaltrials.gov) - P1/2 | N=110 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Unknown status ➔ Completed

Trial completion • Dyslipidemia

The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Unknown status ➔ Completed

Trial completion

Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage (clinicaltrials.gov) - P3 | N=709 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Dyslipidemia • Metabolic Disorders • APOA1 • APOB

Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia and Hyperlipidemia (clinicaltrials.gov) - P3 | N=692 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research (clinicaltrials.gov) - P3 | N=144 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers (clinicaltrials.gov) - P1 | N=159 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Dyslipidemia • Metabolic Disorders