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Equillium Explodes 260% On Positive Covid-19 Results; India Approvalsupport@smarteranalyst.com (Ben Mahaney),SmarterAnalyst•July 13, 2020Shares in biotech Equillium (EQ) have almost tripled in Monday’s pre-market trading after the company announced that a clinical trial conducted in India by its partner Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19.
Equillium is currently developing itolizumab to treat severe autoimmune and inflammatory disorders. The stock is currently trading up 260% in the pre-market.
Biocon also announced that the Drugs Controller General of India (DCGI) has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.
Based on the encouraging topline results and DCGI approval, Equillium revealed that it is now planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).
Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month.
As reported by Biocon:
In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recoveredThe mortality benefit observed in the itolizumab arm was statistically significantConsistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, CEO of Equillium.
Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of
Equillium is currently developing itolizumab to treat severe autoimmune and inflammatory disorders. The stock is currently trading up 260% in the pre-market.
Biocon also announced that the Drugs Controller General of India (DCGI) has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.
Based on the encouraging topline results and DCGI approval, Equillium revealed that it is now planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).
Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month.
As reported by Biocon:
In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recoveredThe mortality benefit observed in the itolizumab arm was statistically significantConsistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, CEO of Equillium.
Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of
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Equillium目前正在开发乙醇单抗治疗严重的自身免疫和炎症性疾病。该股票目前在盘前交易中上涨了260％。
Biocon还宣布，印度药品总局局长（DCGI）已准许在印度的中重度急性呼吸窘迫综合征（ARDS）的COVID-19患者中紧急使用乙醇单抗治疗细胞因子释放综合征（CRS）。
基于令人鼓舞的营收结果和DCGI批准，Equillium透露，它现在计划在COVID-19患者中进行itolizumab的全球随机对照临床试验，并将为此提交美国研究新药申请（IND）。
Biocon在印度的四家医院进行了一项随机，开放标签研究，纳入了30例中重度ARDS住院的COVID-19患者。20名患者被随机分配接受itolizumab联合最佳支持治疗，而10名患者仅接受最佳支持治疗。主要终点是一个月的死亡率。
据Biocon报告：
阿托珠单抗组无死亡病例，所有患者均已康复。在对照组，三名患者死亡，其余患者已康复阿托珠单抗组观察到的死亡率获益具有统计学意义与观察到的临床改善相一致，接受乙醇单抗的患者的炎症细胞因子也明显减少Equillium首席执行官Bruce Steel说：“ Biocon报道的这项临床试验的结果令人鼓舞，并支持一种假设，即izuzumab的新型免疫调节机制有望解决COVID-19患者所经历的严重免疫炎症并发症。”
Itolizumab是一流的免疫调节抗体，具有新颖的作用机制，可抑制在多种自身免疫和炎性疾病中释放促炎性细胞因子的病原性T细胞的活性和运输。通过与Biocon的独家合作和许可协议，Equillium获得了在美国，加拿大，澳大利亚和新西兰开发和商业化乙醇单抗的权利。
Equillium目前正在根据两个开放的美国IND评估itolizumab，以治疗急性移植物抗宿主病和狼疮肾炎，并在澳大利亚和新西兰进行不受控制的哮喘的临床研究。
3月，由于新出现的COVID-19大流行，Equillium宣布将暂停针对不受控制的哮喘的EQUIP试验和针对狼疮性肾炎的EQUALIZE试验。Equillium现在宣布，这两项研究均已恢复患者入组。
两名分析师最近在情商中发布了买入评级。这是与 平均目标价 为$ 12 Stifel Nicolaus分析师 Derek Archila在收到 最新消息后重申了对该股票的买入评级。
“我们注意到，在住院的COVID-19患者中进行的试验规模很小（n = 30），是开放标签的，并且是护理标准之上的，几乎没有数据共享，但是根据Biocon / EQ新闻稿，糖单抗组确实显示了在一个月内（主要终点）对死亡率具有统计学意义的显着收益。”他告诉投资者。
目前的文献表明，约有8％的COVID-19患者发展为ARDS，如果阿托珠单抗的定价与吉利德（ GILD ）的瑞德昔韦（每疗程约2,500-3,000美元）相匹配，这可能是情商的重要市场机会，阿奇拉补充说。（请参阅TipRanks上的EQ股票分析）。
澳大利亚临时批准吉利德的Covid-19治疗
吉利德宣布Covid-19治疗Remdesivir降低死亡率风险
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Smarter Analyst的最新文章：分析师对迪斯尼世界重新开放，分析师乐观阿里巴巴联合创始人马云将赌注降低到4.8％韩国：吉利德的雷姆昔韦改善了三分之一的Covid-19患者安进再向中国百济神州注资4.21亿美元开始对话登录以发布消息。印度的Biocon获得批准在冠状病毒患者中使用药物路透社 •2020年7月11日
The drug, which is also used to cure the skin disease psoriasis, was cleared by the Drug Controller General of India (DCGI) for usage in India.
The randomised control trial indicated that all the patients treated with Itolizumab responded positively and recovered, said Kiran Mazumdar-Shaw, the firm‘s executive chairperson.
The control group which did not receive Itolizumab unfortunately suffered deaths, she said, adding that the first-in-class drug will save lives and help reduce the mortality rate in India.
Clinical studies involving the drug are being closely watched as nations look for treatments for the disease that has infected over 820,000 people and killed over 22,000 in India.
India recorded 27,114 coronavirus cases in the last 24 hours. The South Asian country‘s coronavirus case tally has made it the nation with the third-biggest outbreak, behind only the United States and Brazil in confirmed infections.
The DGCI earlier this month approved pharmaceutical firm Zydus Cadila to start phase one and phase two human clinical trials of its COVID-19 vaccine. Hyderabad-based Bharat Biotech‘s COVAXIN has also been approved for trials.
(This story has been refiled to add dropped word to in headline, and in last paragraph drops reference to Itolizumab)
(Reporting by Aftab Ahmed; Editing by Rupam Jain and James Drummond)
View reactions (29)Sign in to post a message.29Acute Respiratory Distress Syndrome (ARDS) Epidemiology 2017-2030 - ResearchAndMarkets.comBusiness Wire•July 13, 2020
This report delivers an in-depth understanding of the disease, historical and forecasted Acute Respiratory Distress Syndrome (ARDS) epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
Epidemiology Perspective
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Population of ARDS, Severity-specific Incidence of ARDS and Incidence of ARDS by Risk Factors scenario of Acute Respiratory Distress Syndrome (ARDS) in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
Epidemiology Segmentation
In the 7MM, the total incident population of ARDS is estimated to be 799,872 in 2017.Generally, the highest number of incident cases were assessed for ARDS due to pneumonia, in all the 7MM countries, except the United Kingdom, in which sepsis was the primary risk factor for ARDS.The estimates show a higher incidence of ARDS in the United States with 495,655 cases in 2017.Scope of the Report
The report covers the descriptive overview of Acute Respiratory Distress Syndrome (ARDS), explaining its causes, signs and symptoms, pathophysiology and currently available therapies.The report provides insight into the 7MM historical and forecasted patient pool covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan.The report assesses the disease risk and burden and highlights the unmet needs of Acute Respiratory Distress Syndrome (ARDS).The report provides the segmentation of the disease epidemiology for 7MM by Total Prevalent Cases of Acute Respiratory Distress Syndrome (ARDS), Total Diagnosed and Treated Cases of Acute Respiratory Distress Syndrome (ARDS).Report Highlights
Eleven-Year Forecast of Acute Respiratory Distress Syndrome (ARDS)7MM CoverageTotal Incident Population of ARDSSeverity-specific Incidence of ARDSIncidence of ARDS by Risk FactorsTotal Incident Population of Acute Respiratory Distress Syndrome (ARDS) in the 7MM is estimated to increase at a CAGR of 1.07%Severity-specific Incident Population of Acute Respiratory Distress Syndrome (ARDS) in the 7MM is projected to rise at a CAGR of 0.92%.Key Questions Answered
What is the disease risk, burden and unmet needs of Acute Respiratory Distress Syndrome (ARDS)?What is the historical Acute Respiratory Distress Syndrome (ARDS) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?What would be the forecasted patient pool of Acute Respiratory Distress Syndrome (ARDS) at the 7MM level?What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Acute Respiratory Distress Syndrome (ARDS)?Out of the countries mentioned above, which country would have the highest prevalent population of Acute Respiratory Distress Syndrome (ARDS) during the forecast period (2020-2030)?At what CAGR the population is expected to grow across the 7MM during the forecast period (2020-2030)?Key Topics Covered
1 Key Insights
2 Executive Summary
3 SWOT Analysis
4 Acute Respiratory Distress Syndrome (ARDS): Epidemiology Overview at a Glance
4.1 Total Epidemiology Share (%) Distribution of ARDS in 2017
4.2 Total Epidemiology Share (%) Distribution of ARDS in 2030
5 Acute Respiratory Distress Syndrome (ARDS): Disease Background and Overview
5.1 Introduction
5.1.1 Consensus Definitions of Acute Lung Injury and Acute Respiratory Distress Syndrome (ARDS)
5.1.2 Development of Berlin Definition of ARDS
5.1.3 Problems with the AECC definition and subsequent Berlin definition of acute respiratory distress syndrome (ARDS)
5.2 Causes and Risk Factors
5.2.1 Risk Factors of Acute Respiratory Distress Syndrome (ARDS)
5.3 Pathophysiology of Acute Respiratory Distress Syndrome (ARDS)
5.3.1 Inflammatory Processes in ARDS
5.3.2 The initial event of injury
5.3.3 Endothelial Damage
5.3.4 Specific Mediators of Inflammation and Lung Damage in ARDS
5.3.5 Altered Pulmonary Physiology in ARDS
5.3.6 Genetics
5.4 Stages of Acute Respiratory Distress Syndrome (ARDS)
5.5 Ventilator-Induced Lung Injury (VILI)
5.6 Major Determinants of VILI
5.6.1 Ventilator determinants of VILI
5.6.2 Patient determinants of VILI
5.7 Diagnosis of Acute Respiratory Distress Syndrome (ARDS)
5.7.1 Imaging techniques in ARDS
5.7.2 Imaging findings in ARDS
5.7.3 Differential Diagnosis
6 Recognized Establishments
7 Epidemiology and Patient Population
7.1 Key Findings
7.2 Methodology
8 7MM Epidemiology Analysis
8.1 Total Incident Population of Acute Respiratory Distress Syndrome (ARDS) in the 7MM
8.2 Severity-specific Incident Population of Acute Respiratory Distress Syndrome (ARDS) in the 7MM
9 United States Epidemiology
9.1 Assumptions and Rationale
9.2 Total Incident Population of Acute Respiratory Distress Syndrome (ARDS) in the United States
9.3 Severity-specific Incident Population of ARDS in the United States
9.4 Incident Population of ARDS by Risk Factors in the United States
10 EU5 Epidemiology
10.1 Germany Epidemiology
10.1.1 Assumptions and Rationale
10.1.2 Total Incident Population of Acute Respiratory Distress Syndrome (ARDS) in Germany
10.1.3 Severity-specific Incidence of ARDS in Germany
10.1.4按危险因素分类的德国ARDS事件人口
10.2法国流行病学
10.3意大利流行病学
10.4西班牙流行病学
10.5英国流行病学
11日本流行病学
11.1假设和理由
11.2日本急性呼吸窘迫综合征（ARDS）的总事件人口
11.3在日本ARDS的特定病情
11.4按危险因素分列的日本ARDS事件人口
有关此报告的更多信息，请访问https://www.researchandmarkets.com/r/42wd8c
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