New at-home RSV treatment represents a potential breakthrough in addressing the burden of respiratory diseases, especially in vulnerable pediatric and elderly populations
DURHAM, NC, USA I February 03, 2025 I Inhalon Biopharma, Inc. (Inhalon), a clinical-stage company advancing a first-in-class inhaled antibody platform for treating acute respiratory infections (ARI), today announced the completion of IND-enabling studies for its respiratory syncytial virus (RSV) candidate, IN-002, and plans to advance its inhaled-antibody therapy into a human challenge study in 2026. The company also announced a contract with hVIVO (AIM: HVO), a fast-growing specialist contract research organization and the world leader in human challenge trials, to conduct the Phase 2a trial.
Inhalon’s RSV candidate is one of several potential therapies being developed based on the company’s inhaled antibody technology for acute respiratory infections. The inhaled route of administration delivers therapeutic antibodies directly to the site of infection in the airways using a handheld nebulizer, rather than dosing treatments via oral or intravenous methods. Multiple animal models have shown the inhaled treatment approach to be much more effective at treating respiratory infections, making it likely to reduce costs and ease the burden of care on patients and the health care system.
“The treatment paradigm for respiratory infections is ripe for disruptive innovation. Preventive immunizations are underutilized, especially in RSV, where vaccine usage is now expected to be one-third of original estimates. As many as 30-50% of immunized patients experience breakthrough infection, leaving vulnerable populations – infants, toddlers, and the elderly – at high risk of severe infection. There are currently no approved treatments for the underlying RSV infection,” said John Whelan, president and chief executive officer of Inhalon Biopharma. “Inhalon’s inhaled antibody treatment approach not only targets the underlying pathophysiology of RSV and other respiratory infections, but also provides painless, self-administration by patients in their own homes, potentially reducing hospitalizations.”
A prior clinical study1 comparing an Inhalon-developed inhaled antibody therapy and an antibody therapy approved for intravenous use demonstrated that Inhalon’s antibodies maintain full activity following nebulization and can be dosed uniformly to all parts of the respiratory tract, including the deep lung. The study found 30-fold to 100-fold higher concentrations of the antiviral antibody in the respiratory tracts of subjects who received inhaled dosing compared to subjects dosed intravenously, despite subjects with inhaled dosing receiving up to 90% fewer antibodies.
About RSV
RSV remains a leading cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems. Globally, RSV affects an estimated 33 million people annually, leading to approximately 4 million hospitalizations and approximately 101,000 RSV-attributable deaths in children under five years.2 Even with several RSV immunizations approved in recent years, there remains a considerable unmet need for effective antivirals that address acute disease which continues to have a major impact on vulnerable populations worldwide. Adoption of RSV vaccinations has failed to reach expectations and is projected to achieve only 35% of original estimates.3
About Inhalon Biopharma
Inhalon Biopharma, Inc. is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC.
About hVIVO
hVIVO plc (Ticker: HVO) is a rapidly growing early-stage Contract Research Organisation (CRO) and the global leader in human challenge trials. The company delivers end-to-end clinical development services to a diverse and expanding client base, including seven of the world’s ten largest biopharma companies.
hVIVO specialises in conducting human challenge trials across multiple infectious and respiratory indications, leveraging its state-of-the-art quarantine facility in London – the largest of its kind worldwide. The company also offers comprehensive virology and immunology laboratory services under the hLAB brand.
Through its German subsidiary, CRS, hVIVO operates a 120-bed capacity across Mannheim and Kiel, providing early-phase clinical trial services, including first-in-human and proof-of-concept studies. Its second subsidiary, Venn Life Sciences, offers Early Drug Development Consulting and Biometry services to the biopharma sector. The Group provides fully integrated drug development solutions from preclinical stages through Phase II trials, alongside patient recruitment via FluCamp. Additionally, its five clinical sites support outpatient Phase II and III trials, ensuring a seamless and efficient pathway from discovery to late-stage development.
1 Moench, Thomas R. et al. A randomized, double-blind, Phase I study of IN-006, an inhaled antibody treatment for COVID-19. medRxiv. 2022 August 30. https://doi.org/10.1101/2022.08.17.22278748.
2 Li Y et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May 28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19. PMID: 35598608; PMCID: PMC7613574.
3 https://www.globenewswire.com/en/news-release/2024/07/24/2917723/0/en/Airfinity-US-RSV-vaccine-market-estimate-cut-by-64-from-4-7bn-to-1-7bn-a-year-by-2030-following-recommendations-for-single-lifetime-shot-for-elderly-people.html
SOURCE: Inhalon
Post Views: 124
New at-home RSV treatment represents a potential breakthrough in addressing the burden of respiratory diseases, especially in vulnerable pediatric and elderly populations
DURHAM, NC, USA I February 03, 2025 I Inhalon Biopharma, Inc. (Inhalon), a clinical-stage company advancing a first-in-class inhaled antibody platform for treating acute respiratory infections (ARI), today announced the completion of IND-enabling studies for its respiratory syncytial virus (RSV) candidate, IN-002, and plans to advance its inhaled-antibody therapy into a human challenge study in 2026. The company also announced a contract with hVIVO (AIM: HVO), a fast-growing specialist contract research organization and the world leader in human challenge trials, to conduct the Phase 2a trial.
Inhalon’s RSV candidate is one of several potential therapies being developed based on the company’s inhaled antibody technology for acute respiratory infections. The inhaled route of administration delivers therapeutic antibodies directly to the site of infection in the airways using a handheld nebulizer, rather than dosing treatments via oral or intravenous methods. Multiple animal models have shown the inhaled treatment approach to be much more effective at treating respiratory infections, making it likely to reduce costs and ease the burden of care on patients and the health care system.
“The treatment paradigm for respiratory infections is ripe for disruptive innovation. Preventive immunizations are underutilized, especially in RSV, where vaccine usage is now expected to be one-third of original estimates. As many as 30-50% of immunized patients experience breakthrough infection, leaving vulnerable populations – infants, toddlers, and the elderly – at high risk of severe infection. There are currently no approved treatments for the underlying RSV infection,” said John Whelan, president and chief executive officer of Inhalon Biopharma. “Inhalon’s inhaled antibody treatment approach not only targets the underlying pathophysiology of RSV and other respiratory infections, but also provides painless, self-administration by patients in their own homes, potentially reducing hospitalizations.”
A prior clinical study1 comparing an Inhalon-developed inhaled antibody therapy and an antibody therapy approved for intravenous use demonstrated that Inhalon’s antibodies maintain full activity following nebulization and can be dosed uniformly to all parts of the respiratory tract, including the deep lung. The study found 30-fold to 100-fold higher concentrations of the antiviral antibody in the respiratory tracts of subjects who received inhaled dosing compared to subjects dosed intravenously, despite subjects with inhaled dosing receiving up to 90% fewer antibodies.
About RSV
RSV remains a leading cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems. Globally, RSV affects an estimated 33 million people annually, leading to approximately 4 million hospitalizations and approximately 101,000 RSV-attributable deaths in children under five years.2 Even with several RSV immunizations approved in recent years, there remains a considerable unmet need for effective antivirals that address acute disease which continues to have a major impact on vulnerable populations worldwide. Adoption of RSV vaccinations has failed to reach expectations and is projected to achieve only 35% of original estimates.3
About Inhalon Biopharma
Inhalon Biopharma, Inc. is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC.
About hVIVO
hVIVO plc (Ticker: HVO) is a rapidly growing early-stage Contract Research Organisation (CRO) and the global leader in human challenge trials. The company delivers end-to-end clinical development services to a diverse and expanding client base, including seven of the world’s ten largest biopharma companies.
hVIVO specialises in conducting human challenge trials across multiple infectious and respiratory indications, leveraging its state-of-the-art quarantine facility in London – the largest of its kind worldwide. The company also offers comprehensive virology and immunology laboratory services under the hLAB brand.
Through its German subsidiary, CRS, hVIVO operates a 120-bed capacity across Mannheim and Kiel, providing early-phase clinical trial services, including first-in-human and proof-of-concept studies. Its second subsidiary, Venn Life Sciences, offers Early Drug Development Consulting and Biometry services to the biopharma sector. The Group provides fully integrated drug development solutions from preclinical stages through Phase II trials, alongside patient recruitment via FluCamp. Additionally, its five clinical sites support outpatient Phase II and III trials, ensuring a seamless and efficient pathway from discovery to late-stage development.
1 Moench, Thomas R. et al. A randomized, double-blind, Phase I study of IN-006, an inhaled antibody treatment for COVID-19. medRxiv. 2022 August 30. https://doi.org/10.1101/2022.08.17.22278748.
2 Li Y et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May 28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19. PMID: 35598608; PMCID: PMC7613574.
3 https://www.globenewswire.com/en/news-release/2024/07/24/2917723/0/en/Airfinity-US-RSV-vaccine-market-estimate-cut-by-64-from-4-7bn-to-1-7bn-a-year-by-2030-following-recommendations-for-single-lifetime-shot-for-elderly-people.html
SOURCE: Inhalon
Post Views: 124
