CCX140 / Amgen, CSL Behring - LARVOL DELTA

A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: ChemoCentryx | N=13 ➔ 5 | Recruiting ➔ Terminated; Program not advancing

Enrollment change • Trial termination • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease

Computational Screening Using a Combination of Ligand-Based Machine Learning and Molecular Docking Methods for the Repurposing of Antivirals Targeting the SARS-CoV-2 Main Protease. (PubMed, Daru) - "Results demonstrated the efficiency of LBVS combined with MD. This combined strategy provided positive evidence showing that the top screened drugs, including CCX-140, which had the lowest MD score, can be reasonably advanced to the in vitro phase. This combined method may accelerate the discovery of therapies for novel or orphan diseases from existing drugs."

Journal • Machine learning • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Interventions for focal segmental glomerulosclerosis in adults. (PubMed, Cochrane Database Syst Rev) - "Five studies (240 participants) compared cyclosporin with or without prednisone with different comparators (no specific treatment, prednisone, methylprednisolone, mycophenolate mofetil (MMF), dexamethasone). Three small studies compared monoclonal antibodies (adalimumab, fresolimumab) with other agents or placebo. Six single small studies compared rituximab with tacrolimus, cyclosporin plus valsartan with cyclosporin alone, MMF with prednisone, chlorambucil plus methylprednisolone and prednisone with no specific treatment, different regimens of dexamethasone and CCX140-B (an antagonist of the chemokine receptor CCR2) with placebo. The final study (109 participants) compared sparsentan, a dual inhibitor of endothelin Type A receptor and of the angiotensin II Type 1 receptor, with irbesartan...Treatment with cyclosporin for at least six months was more likely to achieve complete remission of proteinuria compared with other treatments but there was considerable imprecision..."

Journal • Review • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hypertension • Infectious Disease • Nephrology • Renal Disease • Transplantation

Novel Therapies for Kidney Disease in People with Diabetes. (PubMed, J Clin Endocrinol Metab) - "Trials have yielded promising results in the search for new therapies to manage DKD. Sodium-glucose cotransporter-2 inhibitors and incretin-related therapies have demonstrated benefit and were associated with improved cardiovascular outcomes. Mineralocorticoid-receptor antagonists are another class of agents with increasing evidence of benefits."

Journal • Cardiovascular • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Ophthalmology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

[VIRTUAL] A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY (LUMINA-1 STUDY) TO EVALUATE THE SAFETY AND EFFICACY OF CCX140 IN SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROISS (FSGS)* (ERA-EDTA 2021) - "In the study, CCX140 did not demonstrate a therapeutically meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment. The study provides insights into the natural disease progression of patients with primary or genetic FSGS as part of a clinical trial setting."

Clinical • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Nephrology • Renal Disease

A Study of CCX140-B in Subjects With FSGS (clinicaltrials.gov) - P2; N=46; Completed; Sponsor: ChemoCentryx; Active, not recruiting ➔ Completed

Trial completion • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Renal Disease

VFMCRP and ChemoCentryx announce topline data from phase-II LUMINA-1 trial of CCX140 in focal segmental glomerulosclerosis (FSGS) (Businesswire) - P2, N=46; LUMINA-1 (NCT03536754); Sponsor: ChemoCentryx; "Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc....today announced topline data from a forty-six (46) patient phase-II dose-ranging trial in the orphan kidney disorder, primary Focal Segmental Glomerulosclerosis (FSGS)....In the study, CCX140 did not demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment....'Regrettably the data observed in the dose-ranging phase-II LUMINA-1 trial of CCX140 do not provide a productive way forward in this patient population. While CCX140 won’t move forward in FSGS...'"

P2 data • Focal Segmental Glomerulosclerosis

ChemoCentryx: Q4 & FY 2013 Results (Chemocentryx) - Anticipated 52-week data from P2 trial for diabetic nephropathy in Q4 2014

Anticipated P2 data • Diabetic Nephropathy • Renal Disease

Experimental evidence for the use of CCR2 antagonists in the treatment of type 2 diabetes (Metabolism) - PMID: 23953944; “… the CCR2 antagonist completely blocked the recruitment of inflammatory macrophages to visceral adipose tissue. The mice exhibited reduced hyperglycemia and insulinemia, improved insulin sensitivity, increased circulating adiponectin levels, decreased pancreatic islet size and increased islet number.”

Preclinical • Diabetes

A study to evaluate the safety and efficacy of CCX140-B in subjects with diabetic nephropathy (clinicaltrials.gov) - P2, N=270; Sponsor: ChemoCentryx; Recruiting; N=135 -> 270; Completion Date: Feb 2013 -> Sep 2014.

Enrollment change • Trial completion date • Renal Disease

ChemoCentryx: Q3 2014 Results (Chemocentryx) - Anticipated initiation of P3 trial for diabetic nephropathy in 2015

Anticipated new P3 trial • Diabetic Nephropathy • Renal Disease

ChemoCentryx announces top-line interim results for CCX140, an orally administered CCR2 inhibitor, in an ongoing 52 week phase II trial in patients with diabetic nephropathy (Chemocentryx Press Release) - "Data also showed that patients treated with 5 mg CCX140 once daily experienced a statistically significant reduction of protein in the urine, or proteinuria, as measured by...UACR versus those patients receiving only the standard of care...following two weeks of treatment...with continuing downward trends in UACR observed following 8-weeks (n=259) and 12-weeks (n=208) of treatment with CCX140. The Company indicated that the data support the continued progress of full 52 weeks of dosing in the Phase II trial as planned. Data from the full study are expected in the second half of 2014."

Anticipated P2 data • P2 data • Renal Disease

CCX140: Top-line data from P2 LUMINA-2 trial (NCT03703908) for nephrotic FSGS in H2 2020 (Chemocentryx) - Q1 2020 Results

P2 data • Focal Segmental Glomerulosclerosis • Renal Disease

ChemoCentryx reports fourth quarter 2014 financial results and provides corporate update (GlobeNewswire) - "Present detailed study results from the previously announced CCX140 Phase II trial in patients with diabetic nephropathy at upcoming medical meetings, with the initial presentation expected in the second quarter of 2015; and Conduct an End-of-Phase 2 meeting with the FDA in the second half of 2015."

Anticipated FDA event • Anticipated P2 data • Diabetic Nephropathy • Renal Disease

ChemoCentryx Reports First Quarter 2020 Financial Results and Recent Highlights (GlobeNewswire, ChemoCentryx, Inc.) - "On track to report topline data from the LUMINA-1 Phase II randomized dose-ranging clinical trial of CCX140...in patients with sub-nephrotic primary FSGS, a rare kidney disease in the second quarter of 2020; Open-label LUMINA-2 study continues to enroll...Data from LUMINA-2 are expected in the second half of 2020."

Enrollment status • P2 data • Cardiovascular • Focal Segmental Glomerulosclerosis

CCX140: Expiry of patents in Europe related to composition-of-matter in 2026 (Chemocentryx) - Annual Report 2017: Expiry of patents in Europe related to certain methods of use in 2028; Expiry of patents in ex-US related to composition-of-matter in 2028

Patent • Diabetic Nephropathy • Renal Disease

Safety and efficacy of oral chemokine receptor 2 antagonist CCX140-B in a phase 2 type 2 diabetes study (EASD 2011) - Presentation Time: Thursday, Sep 15, 2011, 4:00 PM - 4:15 PM; P2, N=159; Statistically significant decrease in HbA1c & a higher percentage of HbA1c responders were observed after only 4 weeks of treatment with CCX140-B 10mg QD compared to placebo; No detrimental effects were observed on plasma MCP-1 or blood monocyte levels, & OD oral CCX140-B provided excellent blockade of blood leukocyte CCR2; The novel oral CCR2-specific antagonist CCX140-B was effective, safe & well tolerated

P2 data • Diabetes

ChemoCentryx to host conference call on Friday, December 12, 2014 to discuss top-line phase II results in patients with diabetic nephropathy with CCX140, an orally administered CCR2 inhibitor (GlobeNewswire) - "ChemoCentryx...today announced that it will host a conference call and webcast on Friday, December 12, 2014 at 8:30 a.m. Eastern Time (ET) to present top-line results from its Phase II trial with CCX140...in patients with diabetic nephropathy."

Anticipated P2 data • Diabetic Nephropathy • Renal Disease

Oral chemokine receptor 2 antagonist CCX140-B shows safety and efficacy in type 2 diabetes mellitus (ADA 2011) - Presentation time: June 27, 2011: 3:30 PM - 3:45 PM; P=NA, N=159; A statistically significant decrease in HbA1c was observed after only 4 weeks of treatment with CCX140-B 10mg QD compared to placebo; Once daily oral CCX140-B provided excellent plasma coverage

Diabetes

ChemoCentryx announces positive results in phase II diabetic nephropathy trial with CCR2 Inhibitor CCX140 (GlobeNewswire) - P2, N=332; "ChemoCentryx...today announced positive top-line 52-week data from its Phase II clinical trial in diabetic nephropathy with CCX140...The trial met its primary endpoint by demonstrating that treatment with 5 mg of CCX140 given orally once daily added to a standard of care regimen (SOC) of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor II blocker (ARB) treatment resulted in a statistically significant (p=0.0148) reduction in urinary albumin creatinine ratio (UACR)...The Company plans to present the full results of this clinical trial at upcoming medical meetings."

P2 data • Diabetic Nephropathy • Renal Disease

CCX140: Expiry of patents in US related to composition-of-matter in 2026 (Chemocentryx) - Annual Report 2017: Expiry of patents in US related to pharmaceutical compositions in 2028; Expiry of patents in US covering certain methods of use in 2026 and 2028

Patent • Diabetic Nephropathy • Renal Disease

ChemoCentryx: Analyst Day (Chemocentryx) - "P2, N=159"; "Gateway to Diabetic Nephropathy - Successful Phase II Proof of Concept Trial in Type 2 Diabetics Inhibiting CCR2 with CCX140"; "CCX140 Decreases Fasting Plasma Glucose"

P2 data • Diabetes • Renal Disease

ChemoCentryx Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Highlights (GlobeNewswire, ChemoCentryx, Inc.) - "On track to announce topline data from the LUMINA-1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease, in the second quarter of 2020. The single-arm, open label LUMINA-2 study continues to enroll, evaluating CCX140 in primary FSGS patients with the more severe nephrotic levels of proteinuria, and we expect to announce topline data by year-end 2020."

Enrollment status • P2 data • Trial status

Presentations at ASN Kidney Week 2019 highlight breadth of ChemoCentryx platform in treatment of complement 3 glomerulopathy (C3G) and focal segmental glomerulosclerosis (FSGS) (GlobeNewswire) - "ChemoCentryx...today announced presentations of its lead drug candidates avacopan, a complement 5a receptor inhibitor, and CCX140, an inhibitor of the chemokine receptor known as CCR2, during the American Society of Nephrology (ASN) Kidney Week 2019, the world's premier nephrology meeting, being held November 5-10, 2019 in Washington, DC."

P2 data • Preclinical

ChemoCentryx reports third quarter 2019 financial results and recent highlights (GlobeNewswire) - "Research and development expenses were $18.1 million for the third quarter of 2019, compared to $15.1 million for the same period in 2018. The increase from 2018 to 2019 was primarily attributable to...the two CCX140 LUMINA Phase II clinical trials in patients with FSGS, partially offset by decreases in research and drug discovery expenses."

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