Latest news with #SebastianJohnston
Business Wire
08-05-2025
- Health
- Business Wire
VirTus Respiratory Research Ltd的人体鼻病毒攻毒模型研究结果推动Altesa BioSciences的主导药物进入高级临床试验阶段
伦敦--(BUSINESS WIRE)--(美国商业资讯)-- 专注呼吸系统研究的知名合同研究公司VirTus Respiratory Research Ltd今日宣布，其针对慢性阻塞性肺疾病（COPD）患者开展的鼻病毒人体攻毒模型研究结果，为Altesa BioSciences提供了关键证据，支持将其主导候选药物vapendavir推进至大规模后期临床试验阶段。 鼻病毒感染是导致数百万慢性阻塞性肺病患者出现急性呼吸功能恶化的主要原因，占比至少50%。Altesa首席执行官、美国前卫生部助理部长兼FDA代理局长Brett Giroir博士表示，'在投入数千万美元将vapendavir推进至涉及数千名患者的临床试验之前，通过概念验证研究证实该药物的疗效至关重要。经过全球范围的严格筛选，我们确认VirTus是唯一能够安全、有效且可靠地在真实COPD志愿者中开展此项研究的机构。' 这项随机、安慰剂对照研究招募并评估了40名慢性阻塞性肺病（COPD）志愿者，COPD是全球第三大死亡原因。经过预先筛查的COPD受试者在接种已知安全型鼻病毒毒株后，于症状出现时完成随机分组。本次研究将精准社交媒体推广作为主要招募渠道，触达逾万名潜在志愿者，这一创新性招募策略充分彰显了VirTus为确保受试者高效入组所采用的先进方法。 VirTus联合创始人兼首席医疗官Sebastian Johnston教授表示，'这些积极成果印证了我们人体病毒攻毒模型能够有效地在新药临床研发早期快速评估疗效。该方法能让生物科技和制药合作伙伴获得具有临床意义的早期数据，帮助他们在药物研发管线中做出可靠的继续/终止决策。' VirTus人体病毒攻毒模型为临床试验主办方提供了在受控环境下评估治疗方案的机会，与传统的大规模早期临床开发研究相比，可显著降低不确定性并大幅缩减时间和成本。 Altesa首席医学官、GSK前首席医学官Kate Knobil博士表示，'借助Johnston教授及VirTus团队的丰富经验，我们已掌握如何最优使用vapendavir，使其最大程度改善COPD患者的生活质量——这正是我们矢志追求的终极目标，也是我毕生职业生涯的奋斗方向。' VirTus联合创始人兼董事总经理Michael Edwards博士补充道，'我们非常荣幸能支持Altesa BioSciences取得vapendavir的这些鼓舞性成果。此次成功合作彰显了我们人体攻毒研究的优势与可靠性，进一步强化了我们加速全球呼吸道疾病创新疗法开发的使命。' 关于VirTus Respiratory Research Ltd VirTus Respiratory Research Ltd是由英国帝国理工学院Sebastian Johnston教授与Michael Edwards博士共同领导的合同研究组织（CRO）。VirTus专注于加速呼吸道病毒感染治疗与预防新疗法的开发——这类感染正是哮喘、慢性阻塞性肺疾病（COPD）及支气管扩张等慢性呼吸系统疾病急性发作的首要诱因。VirTus开展从临床前到早期阶段的临床研究，其专长的人体病毒攻毒模型可生成高质量数据，为创新疗法推进至后期研发阶段提供关键支持。 鼻病毒攻毒模型 VirTus Respiratory Research Ltd使用鼻病毒攻毒模型在严格受控、可重复的实验环境中，产生药物临床疗效的早期信号。该模型通过对志愿者实施监测条件下的鼻病毒感染，可全面评估治疗方案对症状、病毒载量及免疫/炎症反应的影响。对合作伙伴而言，这一模型是在开展规模更大、成本更高的IIb/III期试验前至关重要的"继续/终止"决策工具。它能在早期解答包括临床疗效、剂量选择和终点指标优化等关键问题。主办方可借此缩短研发周期、提前获得'继续/终止'决策依据，通过在早期阶段识别有潜力的候选药物或排除无效方案来降低研发风险，最终实现资源优化配置并提高后续研发成功率。 关于Vapendavir 口服片剂vapendavir是一款处于临床阶段的抗病毒药物，对97%的测试鼻病毒株及其他呼吸道肠道病毒均表现出强效活性。该药物通过双重作用机制起效：既能阻断病毒侵入人体细胞，又可抑制病毒复制。目前，Vapendavir针对COPD患者鼻病毒感染的适应症已进入后期临床试验阶段。其作用机制与Gilead Sciences已获FDA批准的HIV衣壳抑制剂lenacapavir类似。 关于COPD 慢性阻塞性肺疾病（COPD）是一种影响全球数亿患者的致命性慢性肺部疾病。作为当前全球第三大死因，COPD患病率随着人口老龄化及持续暴露于吸烟、空气污染等风险因素而不断攀升。该疾病给患者个体和医疗系统均带来沉重负担：一方面因进行性肺功能衰退和频繁急性加重导致高发病率；另一方面长期治疗及反复住院产生的巨额医疗费用（仅美国每年就高达490亿美元）也造成巨大经济压力。 关于Altesa Altesa BioSciences是一家临床阶段制药公司，致力于为人类健康长期面临的重大威胁——高致病性病毒感染，开发新型疗法。这类感染对脆弱人群的影响尤为严重，包括肺部疾病等慢性病患者、老年人以及医疗服务不足社区的众多群体。 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。
Yahoo
07-05-2025
- Health
- Yahoo
Results from the VirTus Respiratory Research Ltd Human Rhinovirus Challenge Model Used to Advance Altesa BioSciences' Lead Medicine into Advanced Clinical Trials
Professor Sebastian Johnston Study conducted by VirTus Respiratory Research demonstrated that vapendavir has potent antiviral activity and improves symptoms in participants with COPD infected with rhinovirus LONDON, May 07, 2025--(BUSINESS WIRE)--VirTus Respiratory Research Ltd, a leading respiratory-focused contract research organisation (CRO), today announced that results from their human rhinovirus challenge model in patients with chronic obstructive pulmonary disease (COPD) provided Altesa BioSciences with compelling evidence to advance their lead drug candidate, vapendavir, into large scale, late-stage clinical trials. Rhinovirus infection is the cause of at least half of the acute respiratory deteriorations experienced by the millions of patients with chronic obstructive lung disease. "Before advancing vapendavir into clinical trials testing vapendavir on thousands of patients costing tens of millions of dollars, it was critical to demonstrate beneficial effects of the drug in a proof-of-concept study," said Dr. Brett Giroir, CEO of Altesa and former US Assistant Secretary for Health and Acting FDA Commissioner. "After literally searching the globe, we determined that VirTus was the only place that could safely, effectively, and reliably conduct this study on actual volunteers with COPD." The randomised, placebo-controlled study enrolled and evaluated 40 volunteers with COPD, the 3rd leading cause of death worldwide. Pre-screened COPD patients were challenged with a known-to-be safe strain of rhinovirus and randomized after onset of symptoms. Recruitment involved contacting over 10,000 potential volunteers primarily through targeted social media campaigns, highlighting the innovative approach VirTus employs to ensure efficient and successful participant engagement. "These positive results underline the effectiveness of our human virus challenge model to rapidly assess clinical efficacy of novel medicines early in their clinical development pathway," said Professor Sebastian Johnston, Co-founder and Chief Medical Officer (CMO) at VirTus. "This approach allows our biotech and pharmaceutical industry partners to gain early, meaningful clinical data, helping them to make confident go/no-go decisions in their drug development pipeline." VirTus' human virus challenge model offers sponsors the opportunity to evaluate treatments in a controlled environment, significantly reducing uncertainty, time and cost associated with much larger, traditional early clinical development studies.
National Post
07-05-2025
- Health
- National Post
Results from the VirTus Respiratory Research Ltd Human Rhinovirus Challenge Model Used to Advance Altesa BioSciences' Lead Medicine into Advanced Clinical Trials
Article content S tudy conducted by VirTus Respiratory Research demonstrated that vapendavir has potent antiviral activity and improves symptoms in participants with COPD infected with rhinovirus Article content Article content LONDON — VirTus Respiratory Research Ltd, a leading respiratory-focused contract research organisation (CRO), today announced that results from their human rhinovirus challenge model in patients with chronic obstructive pulmonary disease (COPD) provided Altesa BioSciences with compelling evidence to advance their lead drug candidate, vapendavir, into large scale, late-stage clinical trials. Article content 'These positive results underline the effectiveness of our human virus challenge model to rapidly assess clinical efficacy of novel medicines early in their clinical development pathway,' said Professor Sebastian Johnston, Co-founder and CMO at Virtus. Article content Rhinovirus infection is the cause of at least half of the acute respiratory deteriorations experienced by the millions of patients with chronic obstructive lung disease. 'Before advancing vapendavir into clinical trials testing vapendavir on thousands of patients costing tens of millions of dollars, it was critical to demonstrate beneficial effects of the drug in a proof-of-concept study,' said Dr. Brett Giroir, CEO of Altesa and former US Assistant Secretary for Health and Acting FDA Commissioner. 'After literally searching the globe, we determined that VirTus was the only place that could safely, effectively, and reliably conduct this study on actual volunteers with COPD.' Article content The randomised, placebo-controlled study enrolled and evaluated 40 volunteers with COPD, the 3 rd leading cause of death worldwide. Pre-screened COPD patients were challenged with a known-to-be safe strain of rhinovirus and randomized after onset of symptoms. Recruitment involved contacting over 10,000 potential volunteers primarily through targeted social media campaigns, highlighting the innovative approach VirTus employs to ensure efficient and successful participant engagement. Article content 'These positive results underline the effectiveness of our human virus challenge model to rapidly assess clinical efficacy of novel medicines early in their clinical development pathway,' said Professor Sebastian Johnston, Co-founder and Chief Medical Officer (CMO) at VirTus. 'This approach allows our biotech and pharmaceutical industry partners to gain early, meaningful clinical data, helping them to make confident go/no-go decisions in their drug development pipeline.' Article content VirTus' human virus challenge model offers sponsors the opportunity to evaluate treatments in a controlled environment, significantly reducing uncertainty, time and cost associated with much larger, traditional early clinical development studies. Article content 'By leveraging the wealth of experience of Professor Johnston and the VirTus team, we have learned how to best deploy vapendavir so that is has the best chance of improving the lives of people with COPD – which is our ultimate goal and one that I have dedicated my career to achieving,' said Dr. Kate Knobil, CMO at Altesa and former CMO of GSK. Dr Michael Edwards, Co-founder and Managing Director at VirTus, added, 'We're delighted to support Altesa BioSciences in achieving these encouraging results with vapendavir. This successful collaboration showcases the strength and reliability of our human challenge studies, reinforcing our mission to accelerate innovative treatments for respiratory illnesses worldwide.' Article content VirTus Respiratory Research Ltd is a CRO co-led by Professor Sebastian Johnston and Dr. Michael Edwards, both of Imperial College London, United Kingdom. VirTus is dedicated to accelerating the development of novel therapies for the treatment and prevention of respiratory virus infections, which are the leading cause of acute attacks (exacerbations) in chronic respiratory diseases such as asthma, COPD and bronchiectasis. VirTus conducts both pre-clinical and early-phase clinical studies, specialising in human virus challenge models to generate high-quality data that supports the advancement of new therapeutics into later-stage development. Article content The rhinovirus challenge model Article content At VirTus Respiratory Research Ltd, the rhinovirus challenge model is used to generate early signals of clinical efficacy in a tightly controlled, reproducible setting. By exposing volunteers to rhinovirus infection under monitored conditions, the model provides detailed assessment of how a treatment impacts symptoms, virus load and immune/inflammatory responses. For our partners, this model acts as a critical go/no-go decision maker ahead of much larger, costlier Phase 2b/3 trials. It helps answer key questions early, including clinical efficacy, dose selection and endpoint optimisation. Sponsors benefit from accelerated timelines, early go/no-go insights, de-risking development programs by identifying promising candidates, or ruling out ineffective ones, at an earlier stage, ultimately optimising resource allocation and increasing the likelihood of downstream success. Article content About Vapendavir Article content Vapendavir, taken orally in pill form, is a clinical-stage antiviral medicine with potent activity against 97% of rhinoviruses tested and other respiratory enteroviruses. It prevents the virus from entering human cells as well as preventing it from reproducing. Vapendavir is currently in advanced clinical trials for the treatment of rhinovirus infections in people living with COPD. Vapendavir has a similar mechanism of action to the FDA approved HIV capsid inhibitor, lenacapavir marketed by Gilead Sciences. Article content About COPD Article content COPD is a life-limiting chronic lung condition that affects hundreds of millions of people worldwide. COPD is now the third leading cause of death globally, with prevalence continuing to rise due to aging populations and ongoing exposure to risk factors such as smoking and air pollution. COPD imposes a huge burden on individuals and healthcare systems alike, with high morbidity due to progressive lung function decline and frequent exacerbations, alongside enormous ($49 billion in the US) healthcare costs associated with long-term treatment and prolonged and frequent hospital admissions. Article content Article content Article content Article content Article content
Business Wire
07-05-2025
- Health
- Business Wire
Results from the VirTus Respiratory Research Ltd Human Rhinovirus Challenge Model Used to Advance Altesa BioSciences' Lead Medicine into Advanced Clinical Trials
LONDON--(BUSINESS WIRE)--VirTus Respiratory Research Ltd, a leading respiratory-focused contract research organisation (CRO), today announced that results from their human rhinovirus challenge model in patients with chronic obstructive pulmonary disease (COPD) provided Altesa BioSciences with compelling evidence to advance their lead drug candidate, vapendavir, into large scale, late-stage clinical trials. "These positive results underline the effectiveness of our human virus challenge model to rapidly assess clinical efficacy of novel medicines early in their clinical development pathway," said Professor Sebastian Johnston, Co-founder and CMO at Virtus. Rhinovirus infection is the cause of at least half of the acute respiratory deteriorations experienced by the millions of patients with chronic obstructive lung disease. 'Before advancing vapendavir into clinical trials testing vapendavir on thousands of patients costing tens of millions of dollars, it was critical to demonstrate beneficial effects of the drug in a proof-of-concept study," said Dr. Brett Giroir, CEO of Altesa and former US Assistant Secretary for Health and Acting FDA Commissioner. 'After literally searching the globe, we determined that VirTus was the only place that could safely, effectively, and reliably conduct this study on actual volunteers with COPD.' The randomised, placebo-controlled study enrolled and evaluated 40 volunteers with COPD, the 3 rd leading cause of death worldwide. Pre-screened COPD patients were challenged with a known-to-be safe strain of rhinovirus and randomized after onset of symptoms. Recruitment involved contacting over 10,000 potential volunteers primarily through targeted social media campaigns, highlighting the innovative approach VirTus employs to ensure efficient and successful participant engagement. "These positive results underline the effectiveness of our human virus challenge model to rapidly assess clinical efficacy of novel medicines early in their clinical development pathway," said Professor Sebastian Johnston, Co-founder and Chief Medical Officer (CMO) at VirTus. "This approach allows our biotech and pharmaceutical industry partners to gain early, meaningful clinical data, helping them to make confident go/no-go decisions in their drug development pipeline." VirTus' human virus challenge model offers sponsors the opportunity to evaluate treatments in a controlled environment, significantly reducing uncertainty, time and cost associated with much larger, traditional early clinical development studies. 'By leveraging the wealth of experience of Professor Johnston and the VirTus team, we have learned how to best deploy vapendavir so that is has the best chance of improving the lives of people with COPD – which is our ultimate goal and one that I have dedicated my career to achieving,' said Dr. Kate Knobil, CMO at Altesa and former CMO of GSK. Dr Michael Edwards, Co-founder and Managing Director at VirTus, added, "We're delighted to support Altesa BioSciences in achieving these encouraging results with vapendavir. This successful collaboration showcases the strength and reliability of our human challenge studies, reinforcing our mission to accelerate innovative treatments for respiratory illnesses worldwide." About VirTus Respiratory Research Ltd VirTus Respiratory Research Ltd is a CRO co-led by Professor Sebastian Johnston and Dr. Michael Edwards, both of Imperial College London, United Kingdom. VirTus is dedicated to accelerating the development of novel therapies for the treatment and prevention of respiratory virus infections, which are the leading cause of acute attacks (exacerbations) in chronic respiratory diseases such as asthma, COPD and bronchiectasis. VirTus conducts both pre-clinical and early-phase clinical studies, specialising in human virus challenge models to generate high-quality data that supports the advancement of new therapeutics into later-stage development. The rhinovirus challenge model At VirTus Respiratory Research Ltd, the rhinovirus challenge model is used to generate early signals of clinical efficacy in a tightly controlled, reproducible setting. By exposing volunteers to rhinovirus infection under monitored conditions, the model provides detailed assessment of how a treatment impacts symptoms, virus load and immune/inflammatory responses. For our partners, this model acts as a critical go/no-go decision maker ahead of much larger, costlier Phase 2b/3 trials. It helps answer key questions early, including clinical efficacy, dose selection and endpoint optimisation. Sponsors benefit from accelerated timelines, early go/no-go insights, de-risking development programs by identifying promising candidates, or ruling out ineffective ones, at an earlier stage, ultimately optimising resource allocation and increasing the likelihood of downstream success. About Vapendavir Vapendavir, taken orally in pill form, is a clinical-stage antiviral medicine with potent activity against 97% of rhinoviruses tested and other respiratory enteroviruses. It prevents the virus from entering human cells as well as preventing it from reproducing. Vapendavir is currently in advanced clinical trials for the treatment of rhinovirus infections in people living with COPD. Vapendavir has a similar mechanism of action to the FDA approved HIV capsid inhibitor, lenacapavir marketed by Gilead Sciences. About COPD COPD is a life-limiting chronic lung condition that affects hundreds of millions of people worldwide. COPD is now the third leading cause of death globally, with prevalence continuing to rise due to aging populations and ongoing exposure to risk factors such as smoking and air pollution. COPD imposes a huge burden on individuals and healthcare systems alike, with high morbidity due to progressive lung function decline and frequent exacerbations, alongside enormous ($49 billion in the US) healthcare costs associated with long-term treatment and prolonged and frequent hospital admissions. About Altesa Altesa BioSciences is a clinical-stage pharmaceutical company dedicated to developing new treatments for age-old threats to human health: high-consequence viral infections. These infections are particularly severe in vulnerable people, including those with chronic health conditions, like lung diseases, as well as the elderly and many people in underserved communities.
