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
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。
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
3 hours ago
- Yahoo
A new Toronto HIV clinic is 'bridging the gap' in care with free medication and more
A new, free-of-charge clinic in downtown Toronto is hoping to change lives for people living with human immunodeficiency virus (HIV). For people without coverage, it can be next to impossible to afford the medication needed to manage HIV. But access to medication isn't the only service that the Toronto People With AIDS Foundation (PWA) offers. The PWA says it provides immigration services, a food bank and a lunch program to people in Toronto living with HIV. Ower Oberto, the linkage to care manager at the centre, lives with HIV and came to Canada in 2014. "I know how stressful it is not having access to medication," he said. When he first immigrated from Venezuela, Oberto says he didn't know how or even if he could source his medication as a newcomer. "People living with HIV with precarious immigration status, they wouldn't be able to see a doctor or they have to pay that doctor with money out of pocket," he said. "My medication costs more than $1,200 per month." Eleven years later, he now works at the PWA's new clinic providing medication to people with HIV. The clinic was created in partnership with Freddie — a health organization that specializes in HIV prevention and care. "For us it's been an amazing partnership," Oberto said. "We feel like we are family." The PWA's one-room clinic is staffed with two nurses and sees patients once a week, on Wednesdays. Clients don't need to be covered by OHIP or insurance, and vary in immigration status, from international students, to visitors and citizens. "We are bridging all the gaps that have been [letting] … those folks fall into the cracks," Oberto said. "The population we see is a population that is also not easy to support because they don't fill the criteria for the other clinics that are in the city." Clients are set up with patient assistance programs offered by pharmaceutical companies and leave the clinic medication in hand. The clinic is located on the third floor of the PWA's building near Jarvis Street and Queen Street E. Currently the clinic is running a pilot, which began in June. But Oberto has big dreams of scaling up so that it can serve more people with extended hours. "We are looking forward to [having] more days or more hours, because it's getting busier," he said. "We are looking forward … to [having] a bigger clinic and also to have a pharmacy here downstairs." Though the HIV-positive population in Canada is relatively small — approximately 62,790 as of 2020, according to a 2022 Public Health Agency of Canada (PHAC) report. That number is now growing despite education and prevention campaigns. According to PHAC, 2,434 people learned they carried the virus in 2023, up 35 per cent from the previous year. Of those diagnosed across Canada, PHAC estimates 87 per cent are in treatment and 95 per cent of those have suppressed viral loads, which doctors say makes the virus undetectable, untransmittable and prevents it from progressing to AIDS. A decade ago, the United Nations set a goal to eradicate the HIV epidemic by 2030. "This is the best way to do it," Oberto said.
News24
4 hours ago
- News24
The triple whammy: HIV, migration and climate change
More and more research is showing how climate change could trigger increased migration and, with it, another obstacle in managing HIV spread and treatment. But, say public health experts, there are ways to prepare. It wasn't what researchers at HE²RO, the Health Economics and Epidemiology Research Office at Wits University, set out to investigate. In 2020, when interviewing a group of 150 men in Johannesburg, they were trying to figure out where the 'missing men' were, referring to the fact that men tend to use health services far less frequently than women, a pattern that has been seen for years. But as they analysed the data and interviews from the men they recruited, the researchers uncovered something unexpected: two in every five of the men were internal migrants, South Africans moving from one place in the country to another. Even more striking was that one in five of the internal migrants said they were living with HIV, triple the rate of local men who hadn't moved. The study was small, but the findings had the researchers asking new questions: why are HIV rates so high among internal migrants? What role is climate change playing in driving people to migrate? And how can South Africa's health system adapt to people who are on the move — especially given the sudden US funding cuts that have weakened South Africa's HIV programmes, leaving cracks in an already fragile health system? 'This is such a triple whammy. In Southern Africa, there is HIV, which is huge, there is climate change, and then health services that are difficult to access,' says Caroline Govathson, who conducted the HE²RO study. 'We have migration as a central feature in South Africa, and we need to better understand how these issues impact one another.' The science is still emerging, but the links are getting harder to ignore: more and more studies are connecting the dots between climate change, extreme weather events, migration and HIV. The domino effect At the Africa Health Research Institute, Ahri, researchers have been exploring how droughts, floods and other extreme weather events raise the risk of HIV infection or of people falling out of HIV treatment. Collins Iwuji, a senior researcher at Ahri, says there is an indirect but logical flow to HIV threats as the effects of climate change and migration become clearer. It's a sort of sprawling domino effect that works something like this: an extensive body of research by the world's leading authorities on climate change show that climate change is driving more extreme weather events: prolonged droughts, searing heat and sudden destructive floods. When the weather turns extreme, people move, seeking safety, shelter or livelihoods elsewhere. And forced migration can have serious consequences for their HIV risk and treatment. But, says Iwuji, migrants' experiences can differ widely. If people are displaced from their homes, like during sudden flooding catastrophes in one part of the country — what follows may be a massive movement of people to a different part within a very short space of time. But there are also slow onset climate-related events like droughts. People are still forced by climate to flee, but it is a decision that happens over time. What is common to both forms of migration is that it can push people into situations where HIV becomes a bigger threat, Iwuji says. Where migration meets HIV A study of six African countries that looked at migration, food insecurity and transactional sex (sex in exchange for food, shelter or other basic needs) shows that women who migrated because they could not rely on a steady food supply were significantly more likely to report transactional sex. This nearly doubled their HIV risk. The researchers were looking at Eswatini, Lesotho, Namibia, Tanzania, Uganda, and Zambia, but the same factors are at play for migrant women in South Africa. In 2015, a Lancet study showed that both migrant men and women in rural KwaZulu‑Natal were more likely to engage in risky sexual behaviour than non-migrants. 'There's disconnection from social networks or family members, people who would normally provide some sort of social comfort,' explains Iwuji, adding that while they often relocate for work, migrants are still likely to be unemployed. 'All these social factors lead to high risk sexual behaviour which can take the form of transactional sex [ most often it is women who rely on sexual relationships with men to survive ] or it can be in the form of formal commercial sex work or having multiple sexual partners, or not using condoms.' Coceka Nogoduka, a Gauteng-based UNAids adviser for HIV and pandemics preparedness and response, says she has been advocating for countries to develop plans to deal with the health effects of climate for the past 15 years. 'From the field, we are also increasingly hearing of men having sex in a transactional sense. It's a phenomenon that's growing — and they will do that for economic benefits, and not necessarily that they are gay by nature.' These types of high-risk sex, often linked to moving for work or survival, puts people at risk for getting HIV. And that risk cuts two ways. As Iwuji and Nogoduka explain, migrants face the danger of becoming newly infected. And for those living with HIV and are on treatment, there's the danger of being cut off from their medication. Iwuji's research includes a rural KwaZulu-Natal study that shows how drought uproots people's entire lives. They often move away as a 'livelihood strategy', as he calls it, meaning they believe that they will be better able to support themselves and survive elsewhere. The irony is that in the process, their antiretroviral schedule is disrupted, which actually puts their lives at risk. In a session on climate change, mobility and HIV at the 13th IAS Conference on HIV Science in Kigali in July, Rutendo Mukondwa from the nonprofit Organisation for Public Health Interventions and Development in Zimbabwe was one of the speakers making the climate connection. Mukondwa reported on a survey of nearly 900 people across Zimbabwe. Of those living with HIV, three-quarters had experienced interruptions to treatment linked to climate change. He showed how climate shocks collide with poverty and hunger to disrupt HIV treatment. As one HIV-positive study participant explained to the researchers: 'When the crops fail and animals die, there is no food, no income — and without food, taking the pills makes us sick. Sometimes we have to choose between eating and going to the clinic.' The devastating floods in Durban in April 2022 showed how quickly things can fall apart here in South Africa. Bhekisisa reported how some people missed doses for up to two weeks after losing ID documents, which they needed to pick up their antiretroviral medication, or found clinics closed because staff couldn't get to work because of inaccessible roads that were damaged during the floods. The impact of missing HIV treatment for even just a few days can give the virus enough opportunity to multiply in people's bodies. A patient's risk of disease or death increases the longer they don't take the medication because the more the virus multiplies, the more it weakens their immune system. This makes them more likely to get sick or even die. Stopping treatment for too long can also make the medicine stop working properly in future. When people are forced to move, or even when they choose to move, their lives are upended. But their treatment is usually disrupted too and that can put their health on the line, Iwuji says. 'That's a double jeopardy, and when you then add to that the US government's Pepfar funding cuts and their impact on people whose livelihoods are already precarious, it's so many bad things happening at the same time — to create the perfect storm.' After floods, people can be cut off from their HIV medication in two main ways, he says. Either the clinics themselves become inaccessible because of damaged roads or infrastructure, or people have had to move and now find themselves in unfamiliar places, where they are not known to healthcare staff and this makes it harder to get the care they need. The cracks in the system As floods, droughts and heatwaves drive people from their homes, HIV services are disrupted. Some drop out of treatment; others start over at new clinics, having to rebuild trust with unfamiliar health workers. Each move exposes cracks in the health system. When disaster strikes, HIV patients can lose everything: shacks, documents, even their pill containers. 'If a clinic is flooded or its records are gone, you're in trouble!' Nogoduka says. She worries about the individual migrant who is a vulnerable 'nobody' without patient records — or the ability to advocate for the care they need. Nogoduka, who prior to her UNAids role was the acting CEO of the South African National Aids Council, Sanac and the Eastern Cape Coordinator at Pepfar, is just as concerned about what that invisibility means at scale, saying poor data makes it impossible for the health system to plan or budget properly. She says field reports confirm that patients who move from one clinic to another often fall through the cracks because, except for the Western Cape, South Africa still lacks an electronic patient record system. Because most clinics still use paper-based records, a new clinic that a patient moves to wouldn't know which medications that patient had been taking, unless the patient brings along their paper patient card. 'But patients have found a workaround,' she says. 'They simply test afresh for HIV, even if they know they are living with HIV and have been on treatment for years. Then they are treated as a 'new patient'.' Electronic patient records will make it possible to use a patient's ID number or a code unique to each patient to track a patient's medical records. A study in rural northeastern South Africa has shown that undocumented clinic transfers can seriously skew estimates of how many people stay on HIV treatment. Researchers tracking progress towards the use of unique patient identification in the Southern African Development Community found that without a unique ID, it's hard to follow people through testing, treatment and ongoing HIV care. Right now, South Africa's data collection system shows the country is falling behind a United Nations target that tracks how many people who know they have HIV are on treatment. READ | Most people on ARVs stay on them — does our health system know that? Until we have electronic health patients records, says Nogoduka, floods or disasters can cut thousands off from treatment. South Africa's National Digital Health Strategy, 2019–2024 promised such a unique patient identifier to 'facilitate the movement of patients within and across provinces' by 2022, a recommendation which was also in the 2012–2016 eHealth strategy. More than a decade later, it's still not in place. Solving the problem For Iwuji, the solution is long overdue. He points to a World Health Organisation guide published more than a decade ago that countries can use to test how ready clinics and health centres are for climate shocks. It gives clear steps for spotting and fixing weak points, like how clinics can cope with heatwaves or disease outbreaks and how to keep track of patients who relocate. A 2025 study shows that countries that plan for climate shocks like droughts, floods, or displacement as part of their HIV response are much better at keeping services running during crises. The first step is facing the system's failures, says Iwuji. 'You can't solve a problem you don't know about. Once we identify the gaps, we can start scaling up interventions so we can better take care of people on the move.'
Refinery29
a day ago
- Refinery29
MAC VIVA GLAM Joins Forces With BirthFund To Make Maternal Care Mainstream
When it comes to beauty brands giving back, few walk the walk quite like MAC Cosmetics. Through its VIVA GLAM initiative (which celebrated 30 years last year), the brand has donated over half a billion dollars to various causes supporting the fight against HIV/AIDS, as well as environmental impact and gender and racial equality. Today, MAC is furthering its impact by adding maternal care to its roster of VIVA GLAM recipients through a new partnership with birthFUND. The Los Angeles-based organization is dedicated to making midwifery care accessible to families in need. It was partially inspired by founder Elaine Welteroth's experience having her first son in 2022. 'I went into my first pregnancy thinking I was going to give birth in the hospital, the way it's been normalized my whole life,' Welteroth tells Refinery29. 'And yet, I could not find care that made me feel safe in the midst of a surging maternal mortality crisis that we know [disproportionately affects] Black women.' After being introduced to midwifery care in her third trimester, Welteroth says it 'completely changed the trajectory of not just my pregnancy and giving birth, but also my life.' Here's why access to midwifery care matters: According to the World Health Organization, midwives can help prevent over 80% of all maternal deaths, stillbirths, and neonatal deaths. Not to be mistaken for doulas, midwives are clinically trained professionals who offer a holistic approach to care with a focus on both mental and physical well-being. BirthFUND was founded not only with the mission of saving lives but also to empower mothers throughout pregnancy and beyond. 'We're living at a time where up to 50% of mothers describe their birth experiences as 'traumatic', says Welteroth. 'The most empowering thing I have ever done was giving birth on my terms. It changed me fundamentally.' With a $200,000 grant from MAC VIVA GLAM, birthFUND will now be able to completely cover costs for a fourth cohort of families who otherwise would not be able to afford midwifery care. Through its partner organization, The Victoria Project, birthFUND also provides culturally affirming, ongoing support to families and midwives, ensuring care every step of the way. 'VIVA GLAM has always stood for using the power of beauty to spark bold, meaningful change – and this partnership with birthFUND and The Victoria Project is a powerful new chapter in that legacy,' said Rachel Lockett, Vice President of Marketing for M·A·C North America via press release. 'The spirit of this movement is: we don't need permission to save ourselves,' she says. 'We can activate in real time."
