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ChemoCentryx (CCXI) Reports Positive Top-Line Rare Disease Data

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ChemoCentryx, Inc. (CCXI - Free Report) and Vifor Fresenius Medical Care Renal Pharma announced positive top-line data from the ACCOLADE study, evaluating avacopan for the treatment of C3 Glomerulopathy (C3G). C3G is an ultra-rare, progressive kidney disease.

Shares of the company have surged 51% year to date compared with the industry’s growth of 2.9%.

Patients in the multi-center ACCOLADE clinical trial were randomized to receive either 30mg of avacopan twice daily (BID) or placebo for 26 weeks in a double-blind manner. 

The primary endpoint of the study was the change from baseline to week 26 in the C3G Histologic Index for Disease Activity, comparing the changes in kidney histology from biopsy sections taken from patients characterized by elevated levels of C5b-9 complement markers in the blood at the time of study entry (baseline). Biopsies, taken at baseline and after 26 weeks of treatment, showed that the placebo group worsened by 38%, on average, in the C3G Activity Score, while the avacopan group improved by 2%, on average. 

Those patients who received avacopan experienced significant benefits in terms of kidney function and other parameters compared to those who received placebo. 

Avacopan therapy showed a significant slowing of the progression of fibrosis, as assessed by the C3G Histologic Index for Disease Chronicity, as compared to placebo. The avacopan group also demonstrated a statistically significant improvement in estimated Glomerular Filtration Rate (eGFR) from baseline to week 26 as compared to placebo. 

ChemoCentryx and Vifor Fresenius plan to discuss registration pathway with regulatory agencies in US and EU.

We note thatChemoCentryx is also developing avacopan for the treatment of ANCA-associated vasculitis. In September 2020, the FDA accepted for review the company’s NDA for avacopanfor the treatment of ANCA-associated vasculitis and set Jul 7, 2021, as the target action date. The NDA included data from the global, phase III ADVOCATE study.

Zacks Rank & Stocks to Consider

ChemoCentryx currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. (ARPO - Free Report) , ASLAN Pharmaceuticals Ltd. (ASLN - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 66.8% year to date.

ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 1.5% year to date.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.

 

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