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Sunday, April 18, 2021

Itolizumab; the Story of Equillium Inc (NASDAQ: EQ)

Equillium Inc (NASDAQ: EQ) has seen a wild ride in recent months from a start point just over $2 the stock has seen recent highs of $27.06 as its wunderdrug itolizumab (EQ001) gains traction in the fight against coronavirus.

itolizumab (EQ001) recently received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome; significant as India just surpassed Brazil and took the Number 2 spot in Countries most effected by the virus. tolizumab also recently received clearance from the U.S. FDA to initiate a global EQUINOX Phase 3 randomized, placebo-controlled trial of itolizumab in hospitalized COVID-19 patients.

Equillium Inc (NASDAQ: EQ) is a clinical-stage biotechnology company developing products to treat severe autoimmune and inflammatory, or immuno-inflammatory, disorders with high unmet medical need. The Company’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the novel immune checkpoint receptor CD6. Equillium IND with the FDA for acute graft-versus-host disease, or aGVHD, was accepted in July 2018. The FDA granted itolizumab Fast Track designation for the treatment of aGVHD in December 2018 and Orphan Drug designations for both the prevention and treatment of aGVHD in February 2019. In March 2019, the Company initiated a Phase 1b/2 clinical trial of itolizumab for the treatment of aGVHD. In June 2019, Equillium initiated a Phase 1b proof-of-concept clinical trial in Australia for the treatment of uncontrolled asthma. The Company’s IND for lupus nephritis was accepted by the FDA in July 2019, and it initiated a Phase 1b proof-of-concept clinical trial for the treatment of lupus nephritis in September 2019. The FDA granted itolizumab Fast Track designation for the treatment of lupus nephritis in December 2019. The Company continues to enroll patients in the Phase 1b/2 clinical trial of itolizumab for the treatment of aGVHD.

Itolizumab is marketed in India under the trade name “ALZUMAb-L” for the treatment of chronic plaque psoriasis and has received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome; significant as India just surpassed Brazil and took the Number 2 spot in Countries most efected by the virus. tolizumab recently received clearance from the U.S. FDA to begin a Phase 3 study, which we plan to initiate in Q4 2020

Bruce Steel, EQ CEO recently commented: “At Equillium, while we remain focused on our core development programs with itolizumab, we also recognize the urgency of the need to develop drugs to treat COVID-19. We believe itolizumab’s novel immune-modulating mechanism, combined with data from prior human clinical trials – including recent positive interim data from our Phase 1b clinical study in acute graft-versus-host disease and Phase 2 study data in COVID-19 patients reported by our partner Biocon Limited – support our hypothesis that itolizumab may have promise in addressing immuno-inflammatory complications experienced by patients with COVID-19. In October, we received clearance from the U.S. FDA to begin a Phase 3 study, which we plan to initiate in Q4 2020 to evaluate itolizumab as a treatment for patients suffering from life-threatening consequences as a result of COVID-19. We anticipate initial clinical data mid-year 2021. The FDA has also indicated that this study could support regulatory filing of a Biologic License Application (BLA) if it meets its primary and key secondary endpoints. Guidance from the FDA provides a well-defined regulatory pathway and we aim to work expeditiously to develop itolizumab to treat patients in the U.S. and abroad in the face of this global crisis.”

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EQ

On November 10 Equillium announced financial results for the third quarter 2020. During the quarter the Company achieved a number of significant milestones including receiving FDA clearance to initiate global EQUINOX Phase 3 randomized, placebo-controlled trial of itolizumab in hospitalized COVID-19 patients. The Company also presented pre-clinical data demonstrating that modulation of the CD6-ALCAM pathway with itolizumab improves kidney and skin pathology in systemic lupus erythematosus (SLE) at the 2020 American College of Rheumatology (ACR) Virtual Convergence. Presented new data and insights on the CD6-ALCAM pathway in uncontrolled asthma at the European Respiratory Society International Congress 2020 and strengthened the balance sheet by raising a total of $53.0 million in net proceeds from financings in the third quarter 2020, resulting in $90.5 million in cash and investments at the end of the quarter

Bruce Steel, chief executive officer of Equillium stated: “We continue to make significant progress towards our goal of bringing itolizumab to patients suffering from a range of severe immuno-inflammatory disorders,” said . “We are well positioned to continue advancing our core trials including the Phase 1b EQUATE trial in acute graft-versus-host disease (aGVHD) where we recently reported positive response rates across the first three dose cohorts, as well as our Phase 1b EQUIP and EQUALISE trials in uncontrolled asthma and lupus nephritis, respectively. In parallel, we are poised to initiate the global Phase 3 EQUINOX trial of itolizumab in hospitalized COVID-19 patients during this quarter. We look forward to sharing additional updates at our upcoming Analyst Day in December.”

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Equillium is amoung the most exciting stories in small caps; Its lead candidate itolizumab (EQ001) recently received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome; significant as India just surpassed Brazil and took the Number 2 spot in Countries most effected by the virus. tolizumab also recently received clearance from the U.S. FDA to initiate a global EQUINOX Phase 3 randomized, placebo-controlled trial of itolizumab in hospitalized COVID-19 patients. According to their most recent filing the Company has $90.5 million in cash and investments at the end of the quarter. We will be updating on Equillium on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Equillium.

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Disclosure: we hold no position in EQ either long or short and we have not been compensated for this article.

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