| | • | | 30.8% of eblasakimab treated patients achieved EASI-90, compared to 7.9% on placebo (p=0.0028). |
| | • | | 33.1% of eblasakimab-treated patients achieved vIGA-AD score of 0 or 1, compared to 15.1% with placebo (p=0.0327). |
| | • | | 69.8% LS mean reduction in EASI score from baseline, compared to 51.1% on placebo (p=0.0050). |
| | • | | Eblasakimab 400mg Q4W (n=59) |
The eblasakimab 400mg Q4W dosing arm (n=59) did not meet the primary or secondary endpoints with statistical significance.
| | • | | 37.2% of eblasakimab treated patients achieved EASI-75, compared to 24.4% on placebo (p=0.1583). |
| | • | | 17.2% of eblasakimab treated patients achieved EASI-90, compared to 7.9% on placebo (p=0.1513). |
| | • | | 15.0% of eblasakimab-treated patients achieved vIGA-AD score of 0 or 1, compared to 15.1% with placebo (p=0.7457). |
| | • | | 61.9% LS mean reduction in EASI score from baseline, compared to 51.1% on placebo (p=0.1053). |
| | • | | Overall, discontinuation rates were comparable between the treatment arms and higher in the placebo arm. No new safety signals were seen, and the frequency of adverse events (AEs) was comparable between treatment and placebo arms. The most frequently observed AEs across all treatment arms were nasopharyngitis (13.4% across all treatment arms compared to 8.8% for placebo), atopic dermatitis (8.6% compared to 7.0% for placebo), headache (6.9% compared to 7.0% for placebo) and upper respiratory tract infection (6.5% compared to 5.3% for placebo). Rates of conjunctivitis (5.6% compared to 1.8% for placebo), injection site reactions (4.7% compared to 1.8% for placebo) and herpes infections (3.4% compared to 5.3% for placebo) were low. |
Further information is set out in the press release (as corrected) attached hereto as Exhibit 99.1 and which is incorporated by reference herein.
A copy of the investor presentation (as corrected) used in the Company’s webcast on July 6, 2023 and posted on the Company’s website is attached hereto as Exhibit 99.2 and is incorporated by reference herein. Exhibit 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act.
The information contained in this Form 6-K (except Exhibit 99.2) is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (File No. 333-252575), Registration Statement on Form F-3 (File No. 333-254768), Registration Statement on Form F-3 (File No. 333-270835), Registration Statement on Form F-3 (File No. 333-270837), Registration Statement on Form S-8 (File No. 333-252118), Registration Statement on Form S-8 (File No. 333-263843) and Registration Statement on Form S-8 (File No 333-270832).
Forward Looking Statements
This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of the Company. These forward-looking statements may include, but are not limited to, statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialize eblasakimab; the safety and efficacy of eblasakimab; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrolment and clinical trial results for eblasakimab; and the potential for eblasakimab as a first-in-class treatment for AD. The Company’s estimates, projections and other forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, unexpected safety or efficacy data observed during preclinical or clinical studies; the fact that results of earlier studies and trials may not be predictive of future trial results; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and Russia and bank failures on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s Securities and Exchange Commission (“SEC”) filings and reports (Commission File No. 001-38475), including the Company’s Annual Report on Form 20-F filed with the SEC on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements. Estimates, projections and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection or forward-looking statement.
