Imsidolimab demonstrated rapid and sustained efficacy in 6 of 8 (75%) patients with generalized pustular psoriasis (GPP) achieving primary endpoint at week 4 and week 16 Early reduction of erythema with 60% pustules at week 1 improved to 94% at week 4 and 98% reduction at week 16 The GEMINI-1 phase 3 clinical trial was initiated following the end of phase 2 meeting of the FDA and FDA Orphan Drug Designation for the treatment of GPP In addition to GPP, clinical development of imsidolimab will focus on severe acne and moderate to severe hidradenitis suppurativa, with early data Phase 2 line expected in these indications in the first and second semesters of 2022, respectively
SAN DIEGO, Oct 02, 2021 (GLOBE NEWSWIRE) – AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncologic indications, today announced that data from week 16 of the GALLOP phase 2 GPP trial of imsidolimab, its investigational therapeutic anti-interleukin receptor antibody – 36 (IL-36R), were presented at the European Academy of Dermatology and Venereology (EADV) 2021 Congress. The oral presentation, titled “Imsidolimab, an Anti-IL-36 Receptor Monoclonal Antibody, in the Treatment of Generalized Pustular Psoriasis: Results from a Phase 2 Trial”, was presented by Dr. Johann Gudjonsson, Professor of Dermatology at the University from Michigan. .
“These promising results demonstrate the potential of imsidolimab in the treatment of patients with PPG,” said Dr. Johann Gudjonsson. “PPG is a seriously debilitating and potentially fatal dermatological disease that requires new treatment approaches. I look forward to the advancement of imsidolimab into the Phase 3 GPP trials. “
“I would like to thank all of the patients, physicians, nurses and clinical research collaborators who helped AnaptysBio conduct the GALLOP clinical trial,” said Dr. Paul Lizzul, Medical Director of AnaptysBio. “We are delighted to advance the development of imsidolimab in the areas of GPP, acne and HS in the future. “
Study data The key data available to date for the 8 patients included 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 Scale (CGI) at Week 4 and Week 16 (Table 1 ), without requiring rescue medication. Two of 8 patients (25%) were considered not having met the primary endpoint because they dropped out by day 29. Japanese Dermatology Association Modified Severity 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% at week 4 and 98% at week 16. Dermatologic Quality of Life Index (DLQI), which is a patient-reported measure, achieved a reduction of 6 points at week 4 and 11 points at week 16, each exceeding the minimum clinically significant difference (DMCI) by 4 points. The GPP Physician Global Assessment (GPPPGA) scale was implemented by amendment to the protocol during the trial and was assessed in 4 of 8 patients recruited, where zero (clear) or 1 (almost clear) response was obtained 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 the 7 patients tested. Until week 16, anti-drug antibodies were only detected in one patient, which occurred at week 12 and did not impact the pharmacokinetics or efficacy of imsidolimab. .
Imsidolimab was generally well tolerated and most treatment-related adverse events were mild to moderate and resolved without sequelae.
Design of the Phase 2 GALLOP Trial Eight patients were included in the GALLOP trial at 12 sites in the United States and Europe. The patients were eliminated from the previous treatment and no concomitant treatment was allowed during the trial. The main inclusion criteria include active ongoing GPP disease with a minimum mJDA-SI score of 7 and at least 10% of the body surface area covered by active pustules and erythema, while the main exclusion criteria included concomitant dermatological conditions or infection. Patients were treated with an intravenous induction dose of 750 mg imsidolimab on day 1, followed by monthly subcutaneous doses of 100 mg on days 29, 57 and 85. The primary endpoint of this trial was clinical response on the CGI scale at week 4 and week 16 without relief. therapy. Baseline clinical assessments were performed for each patient on day 1 prior to administration of imsidolimab. Missing mJDA-SI data points were imputed using the last observation carryover (LOCF) methodology.
GEMINI Phase 3 Trial Following an end of Phase 2 meeting with the FDA in Q2 2021 during which data from week 16 of the GALLOP Phase 2 trial was reviewed, AnaptysBio initiated a Phase 3 trial 45 patient GPP on imsidolimab, called GEMINI-1, where the primary endpoint is the proportion of patients achieving a GPPPGA score of zero (clear) or 1 (almost clear) at week 4. Patients who completed GEMINI-1 will be included in a subsequent phase 3 GEMINI-2 trial designed to evaluate 6 months of monthly subcutaneous administration of imsidolimab. More than 50 global clinical sites will be involved in screening GPP patients for recruitment. The Company is also continuing to recruit a global GPP patient registry, called RADIANCE, which aims to improve understanding of the GPP patient journey and support the recruitment of GEMINI-1. The FDA has previously granted orphan drug designation to imsidolimab for the treatment of GPP.
Objective of the clinical development of imsidolimab In the future, the Company has prioritized the clinical development of imsidolimab in the GPP where phase 3 GEMINI-1 was initiated, moderate to severe acne where the first-line data Phase 2 ACORNs are expected in the first half of 2022 and moderate to severe hidradenitis suppurativa for which first-line HARP Phase 2 data are expected in the second half of 2022. The company is halting clinical development of imsidolimab for toxicities EGFR-mediated skin and ichthyosis due to changing clinical landscapes for these indications and more slowly than anticipated.
About GPP GPP is a rare, chronic and life-threatening inflammatory disease for which no treatment is currently approved in the United States or Europe. Usually diagnosed after age 30, these patients can die of complications from bacteremia, sepsis, acute respiratory distress syndrome, and heart failure. Most patients are treated off-label with systemic anti-inflammatory agents, including high dose cyclosporine, methotrexate, corticosteroids, retinoids, or biologics, which are often reduced or discontinued due to lack of efficacy or toxicity. GPP is known to be associated with excessive signaling through the IL-36 receptor, which can be caused by genetic mutations and environmental factors. Recent medical claims analyzes conducted by IQVIA indicate that approximately 37,000 unique patients have been diagnosed with GPP at least once, and about 15,000 unique patients have been diagnosed with GPP at least twice, in the United States by a physician between 2017 and 2019 using the International Classification of Diseases. 10th revision (ICD-10) billing code relating to the GPP (L40.1).
About AnaptysBio AnaptysBio is a clinical-stage biotechnology company developing first-class antibody candidates focused on unmet medical needs in the area of inflammation. The Company’s proprietary anti-inflammatory pipeline includes imsidolimab, its anti-IL-36R antibody, previously named ANB019, for the treatment of dermatological inflammatory diseases, including generalized pustular psoriasis, or GPP, acne and hidradenitis suppurative; rosnilimab, its anti-PD-1 agonist program, previously called ANB030, for the treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated; and its BTLA modulator program, ANB032, which is widely applicable to human inflammatory diseases associated with the deregulation of lymphoid and myeloid immune cells. AnaptysBio’s antibody pipeline was developed using its proprietary Somatic Hypermutation Platform, or SHM, which uses in vitro SHMs for antibody discovery and is designed to mimic key features of the immune system. human to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies as part of an immuno-oncology collaboration with GSK, including an anti-PD-1 antagonist antibody (JEMPERLI (dostarlimab-gxly) GSK4057190), an anti-TIM-3 antagonist antibody ( cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386), and an inflammation collaboration with Bristol-Myers Squibb, comprising an anti-PD-1 agonist antibody (CC-90006) currently in clinical development.
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 release of our clinical trial data. , including phase 2 clinical trials of imsidolimab in acne and hidradenitis suppurativa. Statements including words such as “plan”, “continue”, “expect” or “in progress” and statements in the future are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if not fully materialized or turned out to be 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 actual activities or results of the company to differ materially from those expressed in any forward-looking statement, including risks and uncertainties relating to the ability of the company to advance its product candidates, obtain regulatory approval 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 “Risk Factors” in documents that the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company assumes no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date hereof.
Contact: Dennis Mulroy AnaptysBio, Inc. 858-732-0201 [email protected]