– Lirentelimab Met Histologic Co-Primary Endpoint But Missed Symptom Co-Primary Endpoint –
SAN CARLOS, Calif., Sept. 09, 2022 (GLOBE NEWSWIRE) — Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases , today published data from EoDyssey, a 24-week randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with biopsy-confirmed eosinophilic duodenitis (EoD). The trial achieved its histology co-primary endpoint, but it did not achieve statistical significance on the patient-reported symptomatic primary endpoint, both in the intention-to-treat (ITT) ) and in a predefined subpopulation.
The predefined subpopulation was based on a post-hoc analysis of the Company’s Phase 3 ENIGMA2 study and excluded some patients with conditions that could confound the patient-reported symptom endpoint (e.g. non-eosinophilic/non-mast cell-induced esophagus or active irritable bowel syndrome). Although positive numerical trends in the symptom endpoint were observed in this predefined subpopulation, the results were not statistically significant.
The safety results of the trial were generally consistent with previously reported intravenous lirentelimab studies. Mild to moderate infusion-related reactions (including flushing, feeling hot, headache, nausea and/or dizziness) occurred in 19.6% of lirentelimab-treated patients and 14.9% of lirentelimab-treated patients. placebo.
Currently, Allakos does not plan to conduct further studies in eosinophilic gastrointestinal disease, but may do so in the future. Allakos is focusing its development efforts on lirentelimab in atopic dermatitis and chronic spontaneous urticaria and on AK006.
Allakos development programs
Allakos is conducting a randomized, double-blind, placebo-controlled Phase 2 study of subcutaneous lirentelimab in patients with moderate to severe atopic dermatitis and a randomized, double-blind, placebo-controlled Phase 2b study of lirentelimab subcutaneously in patients with chronic atopic dermatitis. spontaneous urticaria. The Company expects to publish key data from these studies in the second half of 2023. In addition, Allakos is advancing AK006, an anti-Siglec-6 antibody that selectively inhibits mast cells, including KIT-mediated signaling, in the IND allowing studies and plans to initiate a Phase 1 study in healthy volunteers in the first half of 2023.
EoDyssey Phase 3 design
The Phase 3 randomized, double-blind, placebo-controlled trial of intravenous lrentelimab enrolled 93 patients with moderate to severe symptoms (based on a patient-reported symptom questionnaire) and duodenal eosinophilia confirmed by biopsy (≥ 30 eosinophils/hpf in 3 hpfs) without stomach eosinophilia (defined as having less than 30 eosinophils/hpf in 5 hpfs). Patients were randomized 1:1 to receive: 3.0 mg/kg lirentelimab administered monthly or placebo monthly. Disease symptoms were measured daily using a patient-reported symptom questionnaire which rated 6 symptoms (abdominal pain, nausea, bloating, early satiety, abdominal cramps, and loss of appetite) each on a scale from 0 to 10 (TSS). The co-primary endpoints of the Phase 3 study were (1) the proportion of patients achieving a histological response (defined as
Allakos is a clinical-stage biotechnology company developing therapeutics targeting immunomodulatory receptors present on immune effector cells implicated in allergic, inflammatory and proliferative diseases. Activation of these immunomodulatory receptors allows direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The Company’s most advanced antibodies are lirentelimab (AK002) and AK006. Lirentelimab selectively targets both mast cells and eosinophils, two types of white blood cells that are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells and eosinophils have been identified as key factors in a number of serious diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Allakos is developing lirentelimab for the treatment of atopic dermatitis, chronic spontaneous urticaria and potentially complementary indications. Lirentelimab has received orphan drug designations for eosinophilic (EG) gastritis, EoD and eosinophilic esophagitis (EoE) from the United States Food and Drug Administration. AK006 targets Siglec-6, an inhibitory receptor selectively expressed on mast cells. In preclinical research, AK006 appears to provide more profound mast cell inhibition than lirentelimab and, in addition to its inhibitory activity, reduces mast cell count. Allakos plans to begin human studies with AK006 in the first half of 2023. For more information, please visit the Company’s website at www.allakos.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, Allakos’ progress, business plans and areas of interest, the expected timing of key data releases from its Phase 2 and 2b studies of lrentelimab, the progress of IND studies for AK006 and the launch of a phase 1 study with AK006. These statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including, but not limited to: the stages of clinical development of the Allakos medicines; Allakos’ ability to initiate clinical trials for AK006 in a timely manner; Allakos’ ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the recruitment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the results of preclinical testing and early-stage trials; Allakos’ ability to obtain regulatory approvals to commercialize its product candidates; market acceptance of Allakos’ product candidates; uncertainties related to projections of the size of patient populations suffering from the diseases targeted by Allakos; Allakos’ ability to advance additional product candidates beyond lirentelimab; Allakos’ ability to obtain additional capital to fund its operations; general economic and market conditions; and other risks. Information regarding the above and additional risks can be found in the section titled “Risk Factors” set forth in Allakos’ most recent Annual Report on Form 10-K filed with the SEC on March 1, 2022, Allakos’ Quarterly Report on Form 10-Q filed with the SEC on August 4, 2022, and future reports to be filed with the SEC. These materials contain and identify important factors that could cause Allakos’ actual results to differ materially from those contained in Allakos’ forward-looking statements. All forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be taken to represent the views of Allakos as of any date subsequent to the date of this press release.
Source: Allakos Inc.
Adam Tomasi, President and Chief Operating Officer
Alex Schwartz, Vice President of Strategic Finance and Investor Relations