An Open-label, Single-dose Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]Vapendavir in Healthy Male Subjects

The goal of this clinical trial is to assess how the body processes, breaks down and removes a new test medicine (vapendavir) from the body in healthy male participants.The main question it aims to answer is how the body handles the test medicine. In order to do that, the test medicine will be radiolabeled to track the test medicine in the body.
Healthy male participants who meet entry criteria will be admitted to the clinic for a duration of approximately 9 days (Day -1 to Day 8). Participants will be admitted in the evening on the day before dosing (Day -1). Participants will take a single oral dose of radiolabeled vapendavir on Day 1 and have samples collected and safety tests completed during various times throughout their stay in the the clinic. The safety tests will provide additional information on the safety and tolerability of the test medicine.

Start Date12 Mar 2025

Sponsor / Collaborator

Altesa BioSciences, Inc.

NCT06149494

/ Active, not recruitingPhase 2

A Trial in Participants With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate the Impact of Vapendavir on the Development of Lower Respiratory Tract Symptoms Following Rhinovirus Challenge

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.

Start Date20 Nov 2023

Sponsor / Collaborator

Altesa BioSciences, Inc.

[+1]

NCT05962645

/ CompletedPhase 1

A Phase 1 Study to Confirm the Single- and Multiple-dose Pharmacokinetics and to Evaluate Food Effect of Vapendavir in Healthy Participants and Participants With COPD

Vapendavir (VPV) is potent virostatic antiviral agent active against all known enterovirus species. VPV binds to the viral capsid, thereby inhibiting viral attachment to the target cell and, independently, preventing release of viral RNA (ribonucleic acid) into the cell. Alt VPV-101 is meant to investigate vapendavir in patients with chronic obstructive pulmonary disease (COPD) who develop a rhinoviral infection. This is a Phase 1, open-label, unblinded study. The primary objective of this study is to characterize single and multiple dose (plus a loading dose) plasma PK profiles of VPV in healthy participants (Group A) and participants with COPD (Group B). Group A is an open-label, 2-sequence, and up to a 3-period, cross-over study to assess the single-dose PK parameters and safety of VPV. Healthy participants may opt to participate in only the first 2 periods, all 3 periods or BID dosing, but it is preferred that participants complete all 3 periods. Group B is an open-label, multi-dose investigation of VPV PK parameters and safety in participants with COPD. Post-dose, follow up will continue for a minimum of 14 days and a maximum of 30 days, depending on which Group the participant is in and which periods said participant completes. There is a target for up to 24 adult participants comprised of healthy participants and participants with COPD.

Start Date19 May 2023

Sponsor / Collaborator

Altesa BioSciences, Inc.

100 Clinical Results associated with Vapendavir

100 Translational Medicine associated with Vapendavir

100 Patents (Medical) associated with Vapendavir

Literatures (Medical) associated with Vapendavir

01 Apr 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design and synthesis of novel thioether analogs as promising antiviral agents: In vitro activity against enteroviruses of interest

Article

Author: Silvestri, Romano ; Roche, Manon ; Scio, Pietro ; Bouzidi, Hawa Sophia ; Khoumeri, Omar ; Gattacceca, Florence ; Vanelle, Patrice ; Coluccia, Antonio ; di Giorgio, Carole ; Touret, Franck ; Roux, Hugo

The Enterovirus genus contains two major subgroups: rhinovirus (RV) species A-C and enterovirus (EV) ones A-D. While RV only infects the respiratory system, the EV can cause a wide variety of diseases, ranging from non-specific febrile illness to severe neurologic complications. To date, no curative treatments are commercially available. Our research team had recently developed EV-A71 inhibitors. To improve their activity and broaden their spectrum, we performed optimization of the structure following an iterative cycle of chemical modulations. As a result, we obtained two broad-spectrum inhibitors with micromolar activity against these 3 types of viruses (OM1260: EC₅₀ (MRC-5, EV-A71) = 1.15 μM; EC₅₀ (RD, EV-A71) = 4.38 μM; EC₅₀ (MRC-5, E30) = 0.41 μM; EC₅₀ (MRC-5, CVA24) = 1.15 μM; HR-568: EC₅₀ (MRC-5, EV-A71) = 3.25 μM; EC₅₀ (RD, EV-A71) = 1.53 μM; EC₅₀ (MRC-5, E30) = 0.40 μM; EC₅₀ (MRC-5, CVA24) = 1.22 μM). Docking studies shed light on structure-activity relationships, while time-of-drug addition assays confirmed their intervention during the early step of viral replication. Eventually, some pharmacokinetic modelling has been carried out to evaluate their druggability. All these results showed that OM1260 and HR-568 are promising candidates for further development.

01 Dec 2024·Influenza and Other Respiratory Viruses

Emerging Therapeutics in the Fight Against EV‐D68: A Review of Current Strategies

Review

Author: Kalam, Nida ; Balasubramaniam, Vinod R. M. T.

ABSTRACT:

Enterovirus‐D68 (EV‐D68) was first identified in 1962 in pediatric patients with acute respiratory conditions in California, USA (US). From the 1970s to 2005, EV‐D68 was underestimated due to limited data and serotyping methods. In 2014, the United States experienced outbreaks of acute flaccid myelitis (AFM) in children EV‐D68 positive. WIN‐like compounds (pleconaril, pocapavir, and vapendavir) bind to the virus capsid and have been tested against various enteroviruses (EVs) in clinical trials. However, these compounds encountered issues with resistance and adverse effects, which impeded their approval by the Food and Drug Administration (FDA). Presently, the medical field lacks FDA‐approved antiviral treatments or vaccines for EV‐D68. Ongoing research efforts are dedicated to identifying viable therapeutics to address EV‐D68 infections. This review explores the current advancements in antiviral therapies and potential therapeutics to mitigate the significant impact of EV‐D68 infection control.

01 Oct 2024·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

New potent EV-A71 antivirals targeting capsid

Article

Author: Roche, Manon ; Sciò, Pietro ; Silvestri, Romano ; Di Giorgio, Carole ; Khoumeri, Omar ; Vanelle, Patrice ; Coluccia, Antonio ; Touret, Franck ; Majdi, Chaimae ; Roux, Hugo

The enterovirus is a genus of single-stranded, highly diverse positive-sense RNA viruses, including Human Enterovirus A-D and Human Rhinovirus A-C species. They are responsible for numerous diseases and some infections can progress to life-threatening complications, particularly in children or immunocompromised patients. To date, there is no treatment against enteroviruses on the market, except for polioviruses (vaccine) and EV-A71 (vaccine in China). Following a decrease in enterovirus infections during and shortly after the (SARS-Cov2) lockdown, enterovirus outbreaks were once again detected, notably in young children. This reemergence highlights on the need to develop broad-spectrum treatment against enteroviruses. Over the last year, our research team has identified a new class of small-molecule inhibitors showing anti-EV activity. Targeting the well-known hydrophobic pocket in the viral capsid, these compounds show micromolar activity against EV-A71 and a high selectivity index (SI) (5h: EC_{50, MRC-5} = 0.57 μM, CC_{50, MRC-5} >20 μM, SI > 35; EC_{50, RD} = 4.38 μM, CC_{50, RD} > 40 μM, SI > 9; 6c: EC_{50, MRC-5} = 0.29 μM, CC_{50, MRC-5} >20 μM, SI > 69; EC_{50, RD} = 1.66 μM, CC_{50, RD} > 40 μM, SI > 24; Reference: Vapendavir EC_{50, MRC-5} = 0.36 μM, CC_{50, MRC-5} > 20 μM, EC_{50, RD} = 0.53 μM, CC_{50, RD} > 40 μM, SI > 63). The binding mode of these compounds in complex with enterovirus capsids was analyzed and showed a series of conserved interactions. Consequently, 6c and its derivatives are promising candidates for the treatment of enterovirus infections.

News (Medical) associated with Vapendavir

07 May 2025

·www.businesswire.com

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. https://www.prnewswire.com/news-releases/altesa-biosciences-details-positive-topline-vapendavir-results-from-phase-2-placebo-controlled-rhinovirus-challenge-study-in-copd-patients-302448650.html 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. “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.

Clinical StudyClinical Result

07 May 2025

·www.prnewswire.com

Altesa BioSciences Details Positive Topline Vapendavir Results from Phase 2 Placebo-Controlled Rhinovirus Challenge Study in COPD Patients

Antiviral improved overall patient-reported measures of both upper, lower respiratory symptoms, shortened overall course of illness COLLEGE PARK, Ga., May 7, 2025 /PRNewswire/ -- Altesa BioSciences today announced positive topline results from its Phase 2 placebo-controlled study examining the effects of vapendavir in COPD patients challenged with rhinovirus. In this study, treatment with vapendavir improved overall patient-reported measures of both upper and lower respiratory symptoms and led to a shortened overall course of illness. These positive effects were supported by a reduced level and faster resolution of viral loads in the respiratory system of participants treated with vapendavir. Continue Reading "This is the first study that has shown that an antiviral for rhinovirus infection, the most common cause of COPD exacerbations, can have a positive impact on upper and lower respiratory symptoms. This effect has the potential to reduce the severity of exacerbations or even prevent exacerbations of their disease, which can be devastating for these patients," said Kate Knobil, MD, chief medical officer of Altesa and former chief medical officer of GSK. "Vapendavir demonstrated a consistent beneficial effect across numerous important parameters – suggesting this medicine could become a transformative new therapy for the more than sixteen million Americans and hundreds of millions around the world who daily suffer with COPD." Antiviral improved measures of both upper, lower respiratory symptoms, shortened overall course of illness Post this "Rhinovirus infection is the most commonly identified cause of exacerbations among COPD patients – accounting for more than 45% of these flare-ups," said Dr. Brett Giroir, CEO of Altesa BioSciences and former US Assistant Secretary for Health and former Acting FDA Commissioner. "Our vision is to treat these viral infections with a safe and effective oral pill, which will stop the virus in its tracks before it can cause devastating consequences for patients," he continued. "If we are successful, not only will we save lives and improve the quality of life for patients, but also potentially save billions of dollars in health care expenditures each year." Vapendavir, taken orally in pill form, is a broad-spectrum antiviral medicine that prevents rhinoviruses and related viruses from entering human cells and reproducing. It exhibits potent activity across 97% of rhinoviruses tested and other respiratory enteroviruses. Vapendavir is the only direct-acting antiviral medicine targeting rhinovirus now in human clinical trials. Altesa BioSciences holds exclusive global rights to develop, manufacture, and commercialize vapendavir. Study details Altesa's rhinovirus challenge study was conducted by VirTus Respiratory Research Ltd. in London, United Kingdom, co-led by Professor Sebastian Johnston and Dr. Michael Edwards. With their collaborators at Imperial College London and St. Mary's Hospital, VirTus is the only company in the world to conduct such studies in COPD – and Johnston has done so safely since 2006. Unlike many other challenge studies for other viral illnesses, our challenge model was designed to mimic as closely as possible the experience of COPD patients in the real world, starting treatment only when their symptoms start to worsen. Participants did not receive vapendavir or placebo until they self-reported the onset of symptoms; furthermore, they were not isolated or confined in the clinic during the study – they went home after visits to live in their normal environment. Participants in the study had a diagnosis of Stage 2 COPD and met specific criteria to ensure that the rhinovirus infection would only result in a temporary worsening of their illness. Participants generally developed an upper respiratory illness on the second day after challenge, followed by worsening of lower respiratory symptoms. Vapendavir treatment began after the onset of clinical illness and continued for a total of seven days. Vapendavir was well tolerated and appeared safe; significantly, there were more adverse events and more severe adverse events in the placebo group than in those treated with vapendavir. More detailed results from Altesa's Challenge Study will be submitted for presentation at a future medical congress. About Vapendavir Vapendavir, taken orally in pill form, is an 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 Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease that worsens over time. More than 16.4 million Americans, or 6.6% of U.S. adults, suffer with COPD, which is now among the leading causes of death in the US and globally. Those with limited financial resources, especially those in urban and rural areas, are often diagnosed late, which is associated with worse overall outcomes. About Altesa BioSciences, Inc. 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. About VirTus Respiratory Research Ltd VirTus Respiratory Research Ltd is a contract research organization co-led by Professor Sebastian Johnston and Dr. Michael Edwards, both also of Imperial College London, United Kingdom. VirTus' mission is to accelerate development of new approaches for treatment/prevention of respiratory viral infections, the major cause of acute attacks (exacerbations) of chronic lung diseases including asthma, COPD and bronchiectasis. VirTus conducts pre-clinical studies as well as early clinical studies using their unique human virus challenge studies to help bring new therapies to the clinic. For Media Inquiries, Contact: Mia Heck Email: [email protected] Phone: 210.284.0388 SOURCE Altesa Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

19 Mar 2025

·www.prnewswire.com

Altesa BioSciences Announces Clearance of Investigational New Drug (IND) Application for Vapendavir

Treat underlying cause of COPD versus maintaining status quo of expensive, chronic therapies COLLEGE PARK, Ga., March 19, 2025 /PRNewswire/ -- Altesa BioSciences, Inc., a clinical-stage pharmaceutical company dedicated to developing new treatments for viral infections in vulnerable populations, today announced that the U.S. Food and Drug Administration (FDA) has cleared Altesa's new Investigational New Drug (IND) application for vapendavir for the treatment of rhinovirus infections in people living with COPD. This milestone paves the way for Altesa to initiate clinical trials in the United States for this patient population. "Viral infections are the primary cause of acute deteriorations in lung function and overall health for those living with COPD. Among viral causes, rhinovirus -- the predominant cause of the common cold -- is the most frequent," said Dr. Brett Giroir, CEO of Altesa BioSciences and former US Assistant Secretary for Health and former Acting FDA Commissioner. "The new IND allows us to advance our studies in COPD, already ongoing in the United Kingdom, into the United States." Altesa already has an open IND for vapendavir to treat rhinovirus infections in people with asthma." Vapendavir, taken orally in pill form, is a broad-spectrum antiviral medicine that prevents the virus from entering human cells and reproducing. It exhibits potent activity across 97% of rhinoviruses and other respiratory enteroviruses. Altesa BioSciences holds exclusive global rights to develop, manufacture, and commercialize vapendavir. More than 16.4 million Americans, or 6.6% of U.S. adults, suffer with COPD, which is now among the leading causes of death in the US and globally. Those with limited financial resources, especially those in urban and rural areas, are often diagnosed late, which is associated with worse overall outcomes. In developing vapendavir, Altesa is applying Dr. Giroir's lessons learned from leading testing and diagnostics for the White House Coronavirus Task Force in 2020. Specifically, he said, "our investments in widely accessible diagnostics now enable treatment of the right patient, at the right time, with the right medicine." It is time to apply these lessons to viral infections that cause suffering in our vulnerable populations every year. Vapendavir, Dr. Giroir continued, also holds strong promise to help other patient groups, including those with asthma, other lung diseases, and cancer, and for treating rhinovirus infections in children – a leading cause of pediatric hospitalizations. Altesa's goal is to prevent acute and chronic complications of viral infections in people at risk, and to disrupt the current paradigm of costly, chronic, immune-modifying therapies by instead treating the underlying cause of the acute disease. For Media Inquiries Contact: Mia Heck Cellular: 210.284.0388 Email: [email protected] SOURCE Altesa Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IND

100 Deals associated with Vapendavir

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic disease of respiratory system	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Chronic lung disease	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Complication	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Emphysema	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Enterovirus Infections	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Lower Respiratory Tract Infections	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Pulmonary Disease, Chronic Obstructive	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Viral respiratory infection	Phase 2	United Kingdom	Altesa BioSciences, Inc.	20 Nov 2023
Respiratory Tract Infections	Phase 2	-	Vaxart, Inc.	18 Jan 2017
Asthma	Phase 2	United States	Biota Scientific Management Pty Ltd.	01 Aug 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01175226 (RHINO, CTgov)	Phase 2	Rhinovirus infection \| Asthma	300	BTA798 (BTA798)	qlmrgbuzhp(wmnqueiyml) = uckgcqmddr rmrrjslizt (cjxijvglqi, 1.403) View more	-	01 Jun 2017
				Placebo (Placebo)	qlmrgbuzhp(wmnqueiyml) = twnamhemqn rmrrjslizt (cjxijvglqi, 1.184) View more

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