AnaptysBio Announces British Journal of Dermatology Publication of Imsidolimab (IL-36R) Previously Reported Phase 2 GALLOP Data in Generalized Pustular Psoriasis (GPP)
- Rapid and sustained efficacy demonstrated in GPP patients after only a single dose, achieving primary endpoint at Week 4
- Flare control sustained on monthly subcutaneous doses through Week 16
- Imsidolimab was generally safe and well tolerated with low overall
- Top-line GEMINI-1 Phase 3 trial data expected in Q4 2023
A potentially debilitating and life-threatening systemic inflammatory skin disease, GPP affects an estimated 15,000 to 37,000 individuals in the
“We remain excited and quite pleased with the dramatic effects demonstrated by imsidolimab’s Phase 2 efficacy and safety data and the potential benefit to patients suffering with life threatening inflammatory GPP,” said
In the Phase 2 GALLOP study, a total of eight adult patients with GPP flare were enrolled and received a 750mg IV dose of imsidolimab and six patients were evaluable at both Day 29 and Day 113 and who also completed the study. Clinical responses were observed as early as Day 3, most rapidly for pustulation relative to other visible manifestations of GPP, with continued and consistent improvement across multiple efficacy assessments at Day 8, Day 29, and through Day 113. Of the six patients evaluable on Day 29, all achieved the primary endpoint of clinical response on the clinical global impression scale (CGI). Additionally, the GPP Physician Global Assessment (GPPPGA) scale was implemented by protocol amendment during the trial and was assessed in four of the eight enrolled patients, where zero (clear) or one (almost clear) response was achieved in 50% (two) patients at Week 4. Six of eight patients received a monthly 100mg subcutaneous dose of imsidolimab beginning at Week 4 and continued through Week 12. At Week 16, 75% (three of four) of evaluable patients were responders (clear or almost clear) on the GPPPGA scale.
Imsidolimab was generally well-tolerated. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No patients discontinued the study due to a non-serious TEAE. Two patients experienced serious adverse events (SAEs) that recovered without sequelae. Through Week 16, anti-drug antibodies were detected in one patient, which occurred at Week 12 and did not impact imsidolimab pharmacokinetics, safety or efficacy.
Initial top-line Phase 2 study results were presented at
GEMINI Phase 3 Studies
Patients completing the GEMINI-1 trial can subsequently roll over into GEMINI-2, the second Phase 3 trial for imsidolimab in GPP, and will receive monthly doses of 200mg subcutaneous imsidolimab or placebo. The objective of GEMINI-2 is to assess the efficacy, durability of effect, recurrence of flare, and safety of imsidolimab during up to three years of monthly dosing.
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 imsidolimab’s Phase 3 clinical trial in GPP; and the company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction. 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 its 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
Senior Director, Investor Relations and
Source: AnaptysBio, Inc.