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项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的临床试验A Pre-Season,Randomized,Single-blind,Placebo-controlled,Parallel-group Study to Determine Tolerability+Safety of a New Cumulative Dose of GrassMATAMPL Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.
A Pre-season, Single Site, Single-blind, Parallel Group, Randomized Study to Determine the Tolerability and Safety of Two New Cumulative Doses of Modified Grass Allergens Adsorbed to L-tyrosine With Monophosphoryl Lipid A Adjuvant (Corixa), Phenol Preserved (Grass MATA MPL); Allergy Therapeutics, (UK) Ltd., Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy.
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration.
Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.
Efficacy and Safety/Tolerability of Ragweed MATA MPL, a Randomized, Placebo-Controlled, Double-Blind Study
Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale. The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 ragweed pollen season
100 项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的临床结果
100 项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的转化医学
100 项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的专利(医药)
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项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的文献(医药)2014-01-01·The Journal of allergy and clinical immunology1区 · 医学
Efficacy of a short course of specific immunotherapy in patients with allergic rhinoconjunctivitis to ragweed pollen
1区 · 医学
Article
作者: Patel, Piyush ; Holdich, Tom ; Huber, Birgit ; Fischer von Weikersthal-Drachenberg, Karl J
2012-09-01·Revista brasileira de epidemiologia = Brazilian journal of epidemiology
Review
作者: Carmona-Fonseca, Jaime
1968-05-01·The Journal of pharmacology and experimental therapeutics
Tolerance to drug-induced writhing in mice.
Article
作者: Lasagna, L ; Bianchine, J R ; Macaraeg, P V
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项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的新闻(医药)慢性鼻炎患者中,近一半为过敏性鼻炎,其中又有不少属于花粉过敏。春天对于他们来说,不是可以放松身心的踏青出游,而是避之不及的花粉、草种带来的打喷嚏、流鼻涕、眼睛痒等摆脱不掉的烦恼。好在,市面上已经有许多效果不错的抗过敏药物可以缓解上述症状,比如最常用的口服或鼻喷剂型的抗组胺类药物,可治疗发痒、打喷嚏、流鼻涕,但对于鼻塞效果有限。抗组胺类药物可分为三代:第一代如苯海拉明、扑尔敏、异丙嗪等,价格低廉但副作用较大;第二代如氯雷他定、西替利嗪;第三代如左旋西替利嗪、地氯雷他定等,药效较好,副作用少,但价格稍贵。此外还可口服白三烯受体拮抗剂治疗,与口服抗组胺药联合使用,效果更显著;用糖皮质激素治疗,可直接在患处用药,持续控制炎症反应,遵医嘱使用时副作用较低;可口服或鼻用的解充血药物则能快速疏通鼻塞,如麻黄碱滴鼻剂,但长期使用会有副作用;鼻腔冲洗治疗则是一种安全、方便的辅助疗法,能够清除鼻内过敏原和炎症分泌物,减轻鼻粘膜水肿。除此之外,还有一种免疫疗法,即通过皮下注射或舌下含服,反复接触引起过敏的过敏原以提高患者机体对过敏原的耐受性,但需要长达三至五年的规律治疗,是唯一有可能长期摆脱部分过敏原引起的过敏的办法。Allergy Therapeutics启动关键G306 Grass MATA MPL III 期试验
2022年12月8日,专门从事过敏症诊断和治疗的英国商业生物技术公司Allergy Therapeutics宣布,在其关于短程皮下过敏原特异性免疫疗法(Subcutaneous allergen-specific immunotherapy,SCIT)候选药物Grass
MATA MPL的关键性III期G306试验中,已完成第一位受试者的给药,以评估该候选药物的有效性和安全性。该药物用于治疗由草花粉引起的季节性过敏性鼻炎和/或鼻结膜炎。Grass MATA MPL由微晶酪氨酸吸附的过敏原和新型佐剂单磷酰脂质 A(Monophosphoryl-lipid A,(MPL)结合形成。该技术只需要患者在过敏季节之前接受六次注射即可得到保护。根据先前公布的探索性实地研究G309的主要结果,两个积极治疗组(治疗分别持续6周和14周)与安慰剂组的“花粉高峰季节的综合症状药物评分”之间存在统计学显著差异,为G306的顺利展开提供了有力的支撑。G306是一项多中心、随机、平行组、双盲、安慰剂对照的临床试验,将在美国和欧洲大约120个临床试验地点进行,将招募约1200名患者,将在13周内完成患者的六次注射,预计在2023年第四季度进行数据读出。Allergy
Therapeutics的最终目的很明确,就是要获得欧洲和美国的批准,包括在欧洲扩大处方范围,以及在美国成为第一个短程、皮下、无铝的草过敏疗法。管理层预计Grass MATA MPL在美国的最高销售额将达到 300-400亿美元,有望对Allergy Therapeutics产生变革性影响。不过,该Allergy Therapeutics在草粉花粉过敏疗法的开发上并非一帆风顺。2007年,该公司旗下Pollinex Quattro草粉花粉过敏药物因患者使用后出现麻木和虚弱等症状,遭到FDA叫停整整五年。2009年,该公司还面临巨额债务和现金流断裂的双重危机。但即便中间启动了转型计划,Allergy Therapeutics仍然把重点放在Pollinex
Quattro 平台上,据统计,大约30%的欧洲人和25%的美国人对花草粉过敏。功夫不负有心人,2018年5月,其开发长期停滞不前的草花粉过敏候选药物在中期试验中显示出“非常显著”的剂量反应,公司股价也因此大幅上涨。然而,在2019年3月,其桦树花粉过敏产品III期 B301 试验未能达到其主要目标,公司股价在消息发布当天下跌约43%。Allergy
Therapeutics的另一个研发重点是基于新型病毒样颗粒(virus-like particle,VLP)的短程花生过敏疫苗候选VLP Peanut,在今年1月26日获得了FDA的IND申请,目前I期PROTECT试验的受试者已经过筛选,预计2023年公布数据。花生过敏是最常见的过敏食物之一,症状可从轻微到危及生命。据估计,全球花生过敏市场规模高达80亿美元。图1 Allergy Therapeutics产品管线(图源:Allergy Therapeutics官网)Allergy Therapeutics 首席执行官 Manuel
Llobet表示:“关键性III期G306试验的启动标志着我们正在尽最大的努力将这一创新疗法推广给美国和欧洲数百万受草过敏影响的患者。探索性实地研究G309的结果鼓舞着我们继续推动这一疗法进步。VLP Peanut PROTECT试验的启动则是一个重要的里程碑,不仅证明了Allergy Therapeutics的努力和实力,更有望改变我们以往治疗和对待过敏的方式。”图2 Allergy Therapeutics 首席执行官 Manuel Llobet(图源:Allergy Therapeutics官网)撰文|风立宵排版|风立宵End参考资料:[1]https://www.labiotech.eu/trends-news/allergy-therapeutics-peanut-grass-pollen-allergy-trials/[2]https://www.trinitydelta.org/research-notes/g309-exploratory-grass-trial-on-course-for-h221-read-out/[3]https://www.pmlive.com/pharma_news/positive_mid-stage_trial_gives_allergys_investors_some_welcome_relief_1236309?SQ_DESIGN_NAME=2#[4]https://www.pmlive.com/pharma_news/allergy_tx_hit_hard_as_birch_pollen_product_stumbles_1281861[5]https://www.biospace.com/article/releases/allergy-therapeutics-announces-fda-clearance-of-ind-application-for-novel-peanut-allergy-vaccine-candidate-vlp-peanut/
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100 项与 Pollinex quattro ragweed (Allergy Therapeutics) 相关的药物交易