World News – GB – Equillium announces positive interim data for itolizumab in the first-line treatment of acute graft-versus-host disease


100% overall response rate in Dose Cohort 3 and 80% overall response rate in all cohorts to date

LA JOLLA, Calif., Nov 06, 2020 (GLOBE NEWSWIRE) – Equillium, Inc (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory diseases, announced today positive intermediate data from the third cohort of the open-label phase 1b study on increasing the dose of itolizumab in the first-line treatment of acute graft-versus-host disease (aGVHD) EQUATE is evaluating itolizumab in patients with severe aGVHD along with standard therapy, which typically includes high dose corticosteroids, as no other therapy is currently approved for this indication. Equillium plans to report primary data on all cohorts in the Phase 1b portion of the EQUATE trial in the first half of 2021 and accelerate plans for further development of itolizumab in graft-versus-host disease

In the EQUATE trial, the overall response rate in the first three dose cohorts was 80%, and seven of eight responding patients achieved complete response (CR) and one patient achieved very good response partial (VGPR) on day 29 (VGPR approaches clinical benefit of CR) Responses observed were rapid, with most patients achieving CR within the first 15 days, and durable because patients from the first two cohorts maintained their responses through day 57 to To date, the adverse events reported in the EQUATE trial were consistent with the previously reported safety profile for itolizumab and with those common in the aGVHD patient population When reviewing all the safety, efficacy and pharmacodynamics data, the independent data monitoring committee recommended expanding cohort 3 (1Dose of 6 mg / kg) and recruiting

« We continue to accumulate convincing data in the EQUATE trial – the rapid and sustained response rates in patients treated with itolizumab significantly exceed what was observed in patients with severe aGVHD treated only with steroids, « said Bruce Steel, CEO of Equillium » We plan to initiate the US Food and Drug Administration (FDA) to explore fast-track regulatory pathways to advance itolizumab for the first-line treatment of ‘aGVHD In addition, these data suggest opportunities to expand the potential therapeutic application of itolizumab for patients with chronic GVHD and as a potential preventive treatment for patients who have undergone hematopoietic stem cell transplants. We believe that itolizumab has the potential to be a life-saving drug for aGVHD patients, a serious and potentially fatal disease for which there is currently no approved drug. »

Equillium Receives Fast Track Designation from the FDA for the Treatment of Itolizumab in Patients with aGVHD and Orphan Drugs from the FDA for the Prevention and Treatment of aGVHD Equillium plans to provide updates additional days on the program during its next analyst day on December 4, 2020

About graft versus host disease GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants (allo-HSCT) caused by the transplanted immune system recognizing and attacking the recipient’s body Symptoms of GVHD include rash, itching, skin discoloration, nausea, vomiting, diarrhea, and jaundice, as well as dryness and irritation of the eyes.

GVHD is the leading cause of relapse-free mortality in cancer patients receiving allo-HSCT, and the risk of GVHD limits the number and type of patients receiving HSCT GVHD causes very high morbidity and mortality , with a five-year survival of approximately 53% in patients who respond to steroid therapy and mortality of up to 95% in patients who do not respond to steroids In first-line aGVHD, the published literature (MacMillan et al, 2015) describes baseline response rates to high dose steroid administration in less severe standard risk patients as an overall response rate (ORR) of 69% and an OR of 48%, while in more severe high-risk patients the observed response rates were 43% ORR and 27% CR

About the EQUATE Study The EQUATE Study is a Phase 1b / 2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of itolizumab for the treatment of first-line in patients with GVHD (NCT 03763318) The phase 1b part of the trial is an open-label dose-escalation study in adult patients with severe aGVHD (grades III and IV) who generally respond hurt on steroids Phase 1b data will inform the selection of the dose to be used in the next phase of program development About itolizumab Itolizumab is a clinical-stage first-order 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 cause a number of immunoinflammatory diseases.Itolizumab is currently being evaluated in several clinical trials in patients with diseases including aGVHD, lupus nephritis, uncontrolled asthma, and will soon be evaluated in a clinical trial in patients with COVID-19 Equillium has acquired the rights to itolizumab in an exclusive partnership with Biocon Limited The itolizumab is marketed in India under the trade name « ALZUMAb-L » for the treatment of chronic plaque psoriasis and has received emergency use authorization in India for use. iterating cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome

About EquilliumEquillium is a clinical-stage biotechnology company that draws on a deep understanding of immunobiology to develop new products to treat severe autoimmune and inflammatory diseases with high unmet medical needs Equillium is developing itolizumab for several severe immuno-inflammatory diseases, including COVID-19, aGVHD, lupus nephritis and uncontrolled asthma

Forward-looking statements Statements in this press release concerning matters which are not historical facts are « forward-looking statements » within the meaning of the Private Securities Litigation Reform Act of 1995 As such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied in these forward-looking statements These statements include, but are not limited to, the potential benefit of treating patients with GVHD or chronic GVHD, as well as patients who have undergone hematopoietic stem cell transplantation, with itolizumab, the commercial strategy of Equillium. , Equillium’s plans and expected timeline for the development of itolizumab, including the expected timing for the completion of the EQUATE study and the initiation of a clinical trial in patients with COVID-19, potential for interim data results to be consistent with final results, when available, the potential benefits of itolizumab, the potential for any of the ongoing Equillium results, or clinical trials planned to demonstrate safety or the effectiveness, and impact of the COVID-19 pandemic Risks that contribute to the uncertain nature of forward-looking statements include: the risk that interim results of a clinical trial nics do not necessarily predict final outcome and that one or more of the clinical outcomes may change significantly as patient recruitment continues, as a result of data reviews and as more patient data becomes available potential delays in starting, recruiting and completing clinical trials and the resulting reporting of data; the risk that studies will not be completed as planned; uncertainties associated with Equillium’s capital requirements; Equillium’s plans and product development, including the launch, restart and completion of clinical trials; uncertainties related to the actual impacts and the duration of these impacts caused by the COVID-19 pandemic; uncertainties caused by the recent restart of the EQUIP and EQUALIZE clinical trials after a hiatus; whether the results of clinical trials will validate and support the safety and efficacy of itolizumab; and having to use liquidity in ways or at different times than expected and the impact of market volatility on cash reserves These and other risks and uncertainties are described in more detail under the heading  » risk ”and elsewhere in Equillium’s documents and reports to the United States Securities and Exchange Commission All forward-looking statements contained in this press release speak only as of the date on which they were made Equillium disclaims any obligation to update these statements to reflect events that have occurred or circumstances that exist after the date on which they are made. have been done


Graft versus host disease, organ transplantation, itolizumab, hematopoietic stem cell transplant, NASDAQ

News from the world – GB – Equillium announces positive interim data on the ‘itolizumab for the first-line treatment of acute graft-versus-host disease
Associated title :
Equillium reports positive interim data on itolizumab in the first-line treatment of acute graft-versus-host disease
Equillium (EQ) reports positive interim data for itolizumab in first-line graft-versus-host therapy acute
Equillium gains 4% on more positive itolizumab data


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