On November 14, 2022 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the third quarter 2022 and provided an update on its clinical development programs (Press release, Equillium, NOV 14, 2022, View Source [SID1234623982]).

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"I am proud of what our team has accomplished in the third quarter, including executing a definitive agreement to acquire Metacrine and announcing interim data from the Type B portion of the EQUALISE study in lupus nephritis. Since then, we have also initiated two new studies – a Phase 2 study of EQ101 in subjects with alopecia areata, and a Phase 1 study of EQ102 that will be positioned to treat patients with celiac disease," said Bruce Steel, chief executive officer at Equillium. "The Metacrine acquisition will meaningfully strengthen our cash position, which at closing is expected to add approximately $35 million to the balance sheet and extend our cash runway into 2024, taking us through multiple data catalysts from three different clinical programs over the next year."

Highlights Since the Beginning of Q3 2022:

Announced definitive merger agreement to acquire Metacrine in an all-stock transaction, anticipated to add $35 million in cash to Equillium’s balance sheet at closing. The acquisition also includes Metacrine’s farnesoid X receptor (FXR) platform, including lead molecule MET642, an orally delivered FXR agonist that is a potential first-in-class, non-immunosuppressive treatment for inflammatory bowel disease.

Announced positive interim results from the Type B portion of the EQUALISE study of itolizumab in subjects with lupus nephritis. Subjects were highly proteinuric with a baseline mean urine protein creatinine ratio (UPCR) of 5.8 g/g. Clinically meaningful responses were observed:

By week 28 (or end of study):

3 of 6 (50%) subjects achieved complete response (UPCR < 0.7 g/g)

2 of 6 (33%) subjects achieved partial response (UPCR > 50% reduction)

4 of 6 (67%) subjects achieved greater than 80% reduction in UPCR

In all subjects receiving more than one dose:

8 of 12 (67%) subjects achieved greater than 50% reduction in UPCR

60% average reduction in UPCR (over 3g of proteinuria)

Subjects titrated steroid dose to < 7.5 mg/day consistent with EULAR/ERA-EDTA recommendations

Initiated a multicenter, Phase 2 open-label, proof-of-concept study of EQ101 in adult subjects between 18 and 60 years of age, with at least 35% scalp hair loss due to alopecia areata. Approximately 30 subjects will be enrolled in the study where they will be dosed intravenously once weekly for 24 weeks.

Initiated a Phase 1 randomized, double-blind, placebo-controlled study of EQ102 administered subcutaneously as single or multiple doses in up to 64 healthy volunteers. The first cohort of eight study participants has been completed and the second cohort has initiated.

Presented data highlighting:

EQ101, a first-in-class, tri-specific cytokine inhibitor selectively targeting IL-2, IL-9 and IL-15 at the receptor level, that may afford significant advantages over other approaches to the treatment of alopecia areata, including JAK inhibition, at the 6th Annual Dermatology Drug Development Summit
Urinary soluble ALCAM (sALCAM) could be a potential biomarker of disease severity in lupus nephritis (LN) and indicative of a patient’s response to treatment at annual meeting of the American College of Rheumatology

Design and development of multi-specific cytokine inhibitors, and the importance of targeting biological synergy to optimize therapeutic outcomes at the 3rd Annual Cytokine-Based Drug Development Summit

Therapeutic potential for multi-cytokine inhibitors such as EQ101 and EQ102, as potentially effective strategies for the treatment of certain autoimmune diseases at the Annual La Jolla Immunology Conference

Anticipated Upcoming Milestones & Catalysts:

Itolizumab – EQUALISE Phase 1b study: topline data from the Type B part of the study in patients with lupus nephritis expected mid-2023

EQ101 – Phase 2 study in subjects with alopecia areata: data expected in 2023

EQ102 – Phase 1 study in healthy volunteers and subjects with celiac disease: data expected in 2023

Third Quarter 2022 Financial Results

Research and development (R&D) expenses for the third quarter of 2022 were $8.8 million, compared with $7.0 million for the same period in 2021. The increase was primarily due to greater clinical development expenses, driven by start-up costs related to the Phase 3 EQUATOR study.

General and administrative (G&A) expenses for the third quarter of 2022 were $4.5 million, compared with $2.9 million for the same period in 2021. The increase was primarily due to higher legal fees related to business development activities and greater employee compensation and overhead expenses.

Net loss for the third quarter of 2022 was $13.7 million, or $(0.40) per basic and diluted share, compared with a net loss of $10.3 million, or $(0.35) per basic and diluted share for the same period in 2021. The increase in net loss was largely attributable to greater operating expenses.

Cash, cash equivalents and short-term investments totaled $44.5 million as of September 30, 2022, compared to $57.6 million as of June 30, 2022. Equillium believes that its cash and investments, together with the additional cash that will be acquired with the expected closing of the Metacrine acquisition, will be sufficient to fund its operations into 2024.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary Multi-Cytokine Platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.
Current MCP assets include EQ101, a first-in-class, selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21.