Imsidolimab (anti-IL-36R Ab) top-line data from the GEMINI-1 Phase 3 trial in GPP is anticipated in the fourth quarter of 2023
Imsidolimab top-line data from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa is anticipated in the third quarter of 2022
Rosnilimab (anti-PD-1 agonist Ab) top-line data from the AZURE Phase 2 trial in moderate-to-severe alopecia areata is anticipated in the first half of 2023
ANB032 (anti-BTLA agonist Ab) IND filing of a Phase 2 clinical trial is anticipated in the second half of 2022
'We are pleased to report promising results for ANB032 in this Phase 1 trial, as we continue to execute across our three wholly owned clinical stage antibody programs,' said Dr.
A total of 96 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single ascending dose (SAD) cohorts received subcutaneous or intravenous single doses of ANB032 or placebo, while multiple ascending dose (MAD) cohorts received four weekly subcutaneous doses of ANB032 or placebo.
ANB032 was generally well-tolerated, no dose limiting toxicities were observed and there were no discontinuations due to adverse events, other than one patient quarantined for potential COVID infection. No serious adverse events (SAEs) were reported. Most adverse events were considered to be mild-to-moderate, of short duration, resolved without sequelae and occurred sporadically in a dose-independent manner. Three severe adverse events (2 blood creatine phosphokinase (CPK) increase and 1 aspartate aminotransferase (AST) increase), none of which were treatment-related, were reported in two subjects in the lowest dose MAD cohort. Three subjects had mild-to-moderate single injection site reactions (ecchymosis; erythema; and pain) of short duration.
Pharmacokinetic analyses demonstrated a favorable profile for ANB032 including an approximate two-week half-life for subcutaneous and intravenous routes of administration. Full BTLA receptor occupancy was observed rapidly within hours and was maintained for greater than 30 days following IV or subcutaneous ANB032 dosing.
ANB032 pharmacodynamic activity resulted in reduction of cell surface BTLA expression on T cells and B cells following dosing. A portion of the cell surface BTLA was shed from the cells as soluble BTLA (sBTLA), while the residual approximately 60% of baseline BTLA on T cells and B cells remained occupied by ANB032. The duration of reduced BTLA expression correlated with receptor occupancy in a dose-dependent manner and was maintained for greater than 30 days following IV or subcutaneous ANB032 dosing.
'ANB032 demonstrated rapid and sustained target engagement on both T cells and B cells. Importantly, reduction of cell surface BTLA expression and the shedding of a portion of the cell surface BTLA as soluble BTLA, which was previously demonstrated to occur with ANB032 treatment in animal models of inflammation where robust efficacy was observed, confirmed the pharmacodynamic activity of ANB032 in humans,' said Dr.
About ANB032
ANB032, a wholly owned anti-BTLA agonist antibody developed by
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Forward-Looking Statements
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 top-line data for our Phase 2 clinical trial of imsidolimab in moderate-to-severe hidradenitis suppurativa, our Phase 3 clinical trial of imsidolimab in GPP and our Phase 2 clinical trial of rosnilimab in moderate-to-severe alopecia areata; the timing of an IND filing for ANB032; and the potential of ANB032 to treat T and/or B cell-mediated human inflammatory diseases. 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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