AnaptysBio Reports Positive Topline Data from Phase 2a Proof-of-Concept Clinical Trial of Etokimab in Severe Eosinophilic Asthma
- Lung function improvement occurred rapidly following a single dose of etokimab, with an 8 percent increase in FEV1 over placebo at Day 2
- FEV1 improvement was sustained throughout the interim analysis period, with an 11 percent increase over placebo at Day 64
- Blood eosinophil reduction was consistent with lung function improvement, with 31 percent and 46 percent reduction over placebo at Day 2 and Day 64, respectively
- Management to host conference call today at
8:30 a.m. EDT
“Eosinophilic asthma is a debilitating medical condition that results from severe inflammation and airway obstruction,” said Dr.
Phase 2a Trial Design
This Phase 2a proof-of-concept trial enrolled 25 adult severe eosinophilic asthma patients, who were randomized between a single 300mg intravenous dose of etokimab or placebo upon enrollment (Day 1) at six sites located in
Key data and observations as of this interim analysis indicate the following:
- Baseline parameters of etokimab-dosed patients (n=12) were 545 blood eosinophils per microliter, 2.5 liters FEV1 and 65 percent predicted FEV1, while placebo-dosed patients (n=13) had 705 blood eosinophils per microliter, 2.5 liters FEV1 and 66 percent predicted FEV1. Nine of 12 (75%) etokimab-dosed patients were male with an average age of 41, while nine of 13 (69%) placebo-dosed patients were male with an average age of 36.
- Etokimab-dosed patients rapidly improved lung function by Day 2, where FEV1 increased by 8 percent over placebo.
- FEV1 increase was sustained at Day 64, where etokimab-dosed patients demonstrated an 11 percent increase over placebo.
- Blood eosinophil reduction, which is a biomarker illustrative of etokimab’s mechanistic breadth, was observed at 31 percent over placebo at Day 2 and sustained to 46 percent over placebo at Day 64. This reduction correlated with FEV1 improvement and was consistent with the blood eosinophil effects observed in a prior single dose etokimab trial in moderate-to-severe atopic dermatitis patients.
- Etokimab was generally well-tolerated by all patients and no serious adverse events were reported as of this interim analysis. No treatment-emergent adverse events were deemed to be etokimab-related, and the most frequent treatment-emergent adverse events reported were single occurrences of moderate strep throat in two etokimab-dosed patients and single occurrences of mild vomiting in two placebo-dosed patients. No exacerbations or rescue therapy usage has been reported as of the interim analysis.
|Parameter||Timepoint||Change Relative to
Day 1 Baseline
|Etokimab (n=12)||Placebo (n=13)||Net|
|FEV1 Increase (%)||Day 2||12%||4%||8%|
|Blood Eosinophil Level
“We are thrilled to have demonstrated proof-of-concept in this single dose Phase 2a trial and look forward to advancing the development of etokimab for patients suffering from eosinophilic asthma,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Genotypic studies have validated the key role played by IL-33 in asthma, and we believe etokimab’s upstream mechanism has the potential for a broad therapeutic benefit across multiple atopic disorders.”
This Phase 2a trial is currently ongoing and the company plans to report full data from this trial at a medical conference in 2019 following trial completion.
Conference Call & Webcast Information
Dial-in: (833) 696-8361 (domestic) or (430) 775-1625 (international)
Conference ID: 5798647
The live webcast and accompanying slides can be accessed under the investor relations section of AnaptysBio’s website at www.anaptysbio.com. A replay of the conference call will be archived under the investor relations section of the
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33 (IL-33), a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including etokimab’s Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients and etokimab’s Phase 2 clinical trial in adult patients with CRSwNP; our design of and our ability to launch a Phase 2 clinical trial of etokimab in adults patients with CRSwNP and a Phase 2b clinical trial of etokimab in eosinophilic asthma; and statements by AnaptysBio’s president and chief executive officer. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the
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Source: AnaptysBio, Inc.