AnaptysBio Presents Updated Data From Imsidolimab Phase 2 GALLOP Trial in Generalized Pustular Psoriasis
- Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 (75%) generalized pustular psoriasis (GPP) patients achieving the primary endpoint at week 4 and week 16
- Early reduction of erythema with pustules by 60% at week 1 improved to 94% reduction at week 4 and 98% reduction at week 16
- Phase 3 GEMINI-1 clinical trial has been initiated subsequent to FDA end-of-Phase 2 meeting and FDA orphan drug designation for the treatment of GPP
- In addition to GPP, imsidolimab clinical development to focus on moderate-to-severe acne and moderate-to-severe hidradenitis suppurativa, with Phase 2 top-line data anticipated in these indications during the first and second halves of 2022, respectively
“These promising results demonstrate the potential for imsidolimab in the treatment of GPP patients,” said Dr.
“I would like to thank all of the patients, physicians, nurses and clinical research collaborators that helped
Key data available to date from the 8 patients enrolled in the GALLOP trial are as follows:
- Six of 8 (75%) patients treated with imsidolimab monotherapy achieved the primary endpoint of response on the clinical global impression (CGI) scale at week 4 and week 16 (Table 1), without requiring rescue medication. Two of 8 (25%) patients were considered to have not met the primary endpoint because they dropped out of the trial prior to Day 29.
Modified Japanese Dermatology Associationseverity index total score (mJDA-SI), which incorporates both dermatological and systemic aspects of GPP, decreased on average by 29% at week 1, 54% at week 4 and 58% at week 16. Erythema with pustules, which clinically defines GPP, decreased by 60% at week 1, 94% by week 4 and 98% by week 16. Dermatology Life Quality Index (DLQI), which is a patient-reported measure, achieved a reduction of 6 points at week 4 and 11 points by week 16, each of which exceeded the minimal clinically importance difference (MCID) of 4 points. GPP Physician Global Assessment (GPPPGA) scale was implemented by protocol amendment during the course of the trial and was assessed in 4 of the 8 enrolled patients, where zero (clear) or 1 (almost clear) response was achieved in 2 (50%) patients at week 4 and 3 (75%) patients at week 16.
- Genotypic testing indicated homozygous wild-type IL-36RN, CARD14 and AP1S3 alleles for all 7 tested patients.
- Through week 16, anti-drug antibodies were only detected in one patient, which occurred at week 12 and did not impact imsidolimab pharmacokinetics or efficacy.
Imsidolimab was generally well-tolerated and most treatment-emergent adverse events were mild to moderate in severity and resolved without sequelae.
|No infusion or injection site reactions were observed. As previously reported, one patient dropped out of the trial following diagnosis of Staphylococcal aureus bacteremia in the first week, which was a serious adverse event deemed to be possibly drug-related. Because the patient was symptomatic prior to dosing and had a prior medical history of bacteremia, a common comorbidity of GPP, the Company does not believe this event is likely attributable to imsidolimab. Another patient dropped out of the study on Day 22 due to investigator reported inadequate efficacy. One patient contracted COVID-19 during the course of the trial, which was mild, unrelated to imsidolimab, and did not lead to study discontinuation.||Endpoint||Baseline||Week 1 Relative to Baseline||Week 4 Relative to Baseline||Week 16 Relative to Baseline|
|CGI Responders||N/A||7 of 8 patients||6 of 8 patients||6 of 8 patients|
|Erythema with Pustules
(% body surface area)
|Table 1. Key endpoints at week 1, 4 and 16 relative to baseline.|
GALLOP Phase 2 Trial Design
Eight patients were enrolled in the GALLOP trial from 12 sites in
GEMINI Phase 3 Trial
Following an end-of-Phase 2 meeting with the FDA in Q2 2021 where week 16 data from the GALLOP Phase 2 trial was reviewed,
Imsidolimab Clinical Development Focus
Going forward, the Company has prioritized clinical development of imsidolimab in GPP where Phase 3 GEMINI-1 has been initiated, moderate-to-severe acne where Phase 2 ACORN top-line data is anticipated in the first half of 2022 and moderate-to-severe hidradenitis suppurativa where Phase 2 HARP top-line data is anticipated in the second half of 2022. The company is discontinuing imsidolimab clinical development for EGFR-mediated skin toxicities and ichthyosis due to evolving clinical landscapes for these indications and slower than anticipated enrollment.
GPP is a rare, chronic life-threatening, inflammatory disease with no currently approved therapies in
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 imsidolimab’s Phase 2 clinical trials in acne and hidradenitis suppurativa. 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
Source: AnaptysBio, Inc.