A phase Ib, open-label, pharmacokinetics and safety study of IN-006 (regdanvimab for nebulization) versus intravenous regdanvimab in healthy volunteers

Start Date07 Jun 2023

Sponsor / Collaborator

Inhalon Biopharma, Inc.

ACTRN12621001235897

/ CompletedPhase 1

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of Nebulized IN-006 in Healthy Volunteers

Start Date22 Sep 2021

Sponsor / Collaborator

Inhalon Biopharma, Inc.

100 Clinical Results associated with Inhalon Biopharma, Inc.

0 Patents (Medical) associated with Inhalon Biopharma, Inc.

Literatures (Medical) associated with Inhalon Biopharma, Inc.

01 Mar 2025·eBioMedicine

A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteers

Article

Author: Hoke, Marshall ; Lickliter, Jason D ; McSweeney, Morgan D ; Park, Yoona ; Kim, Cheolmin ; Lai, Samuel K ; Hutchins, Jeff ; Lee, Soo Young ; Kang, Hyunah ; Botta, Lakshmi ; Brennan, Miles ; Richardson, Zachary ; Moench, Thomas R ; Cho, Jong Moon ; Faurot, Frances ; Whelan, John B ; Farrer, Brian

BACKGROUNDAlthough COVID-19 is predominantly a respiratory tract infection, current antibody treatments are administered by systemic dosing. We hypothesize that inhaled delivery of a monoclonal antibody may be a more effective and convenient route. We investigated the safety, tolerability, and pharmacokinetics of IN-006, a reformulation of regdanvimab for nebulized delivery by a handheld nebulizer.METHODSA Phase 1 study was conducted in healthy volunteers aged 18-55 a Phase 1 unit in Melbourne, Australia (ACTRN12621001235897). Study staff and participants were blinded to treatment assignment, except for pharmacy staff preparing the study drug. The ratio of active:placebo randomization to each cohort was set at 3:1. The primary outcomes were safety and tolerability. Exploratory outcomes were pharmacokinetics of IN-006 in nasal fluid and serum.FINDINGSTwenty-three participants were enrolled and randomized across two single dose and one multiple dose cohorts (30 mg or 90 mg single nebulized dose, or seven daily 90 mg doses). There were no serious adverse events. All enrolled participants completed the study without treatment interruption or discontinuation. All treatment-emergent adverse events were transient, non-dose dependent, and graded mild to moderate in severity. Nebulization was well-tolerated and completed in an average of 6 min. Geometric mean nasal fluid concentrations of IN-006 in the multiple dose cohort were 739.8 μg/mL at 30 min after dosing and 1.2 μg/mL at 22 h. Geometric mean serum levels in the multiple dose cohort peaked at 0.51 μg/mL 3 days after the final dose.INTERPRETATIONIN-006 was well-tolerated and achieved concentrations in the respiratory tract orders of magnitude above the IC₅₀ range typical of antiviral mAbs. These data support further development of nebulized delivery of antiviral mAbs for respiratory infectious disease.FUNDINGThis work was funded by the U.S. Army Medical Research and Development Command (W81XWH-15-9-0001) and regdanvimab was provided by Celltrion, Inc.

medRxiv

A randomized, double-blind, Phase 1 study of IN-006, an inhaled antibody treatment for COVID-19

Author: Park, Yoona ; Hoke, Marshall ; Moench, Thomas R. ; Lai, Samuel K. ; Cho, Jong Moon ; Faurot, Frances ; Lickliter, Jason D. ; Brennan, Miles ; Botta, Lakshmi ; Whelan, John B. ; Kim, Cheolmin ; Lee, Soo Young ; Kang, Hyunah ; McSweeney, Morgan D. ; Hutchins, Jeff ; Richardson, Zachary ; Farrer, Brian

Although COVID-19 is predominantly a respiratory tract infection, current antibody treatments are administered by systemic dosing.We hypothesize that inhaled delivery of a muco-trapping monoclonal antibody would provide a more effective and convenient treatment for COVID-19.We investigated the safety, tolerability, and pharmacokinetics of IN-006, a reformulation of regdanvimab, an approved i.v. treatment for COVID-19, for nebulized delivery by a handheld nebulizer.A Phase 1 study was conducted in healthy volunteers.Study staff and participants were blinded to treatment assignment, except for pharmacy staff preparing the study drug.The primary outcomes were safety and tolerability.Exploratory outcomes were pharmacokinetic measurements of IN-006 in nasal fluid and serum.Twenty-three participants were enrolled and randomized across two single dose and one multiple dose cohorts.There were no serious adverse events (SAEs).All enrolled participants completed the study without treatment interruption or discontinuation.All treatment-emergent adverse events were transient, non-dose dependent, and were graded mild to moderate in severity.Nebulization was well tolerated and completed in a mean of 6 min in the high dose group.Mean nasal fluid concentrations of IN-006 in the multiple dose cohort were 921μg/g of nasal fluid at 30 min after dosing and 5.8μg/g at 22 h.Mean serum levels in the multiple dose cohort peaked at 0.55μg/mL at 3 days after the final dose.IN-006 was well-tolerated and achieved concentrations in the respiratory tract orders of magnitude above its inhibitory concentrationThese data support further clin. development of IN-006.

bioRxiv

Stable nebulization and muco-trapping properties of Regdanvimab/IN-006 supports its development as a potent, dose-saving inhaled therapy for COVID-19

Author: Richardson, Zach ; Cho, Jong Moon ; Park, Yoona ; Hutchins, Jeff ; Lee, Soo Young ; Stewart, Ian ; Kim, Cheolmin ; Aurora, Harendra ; McSweeney, Morgan ; Tiruthani, Karthik ; Schaefer, Alison ; Wolf, Whitney ; Kang, Hyunah ; Lai, Samuel ; Hickey, Anthony J. ; Kumar, Priya

The respiratory tract represents the key target for antiviral delivery in early interventions to prevent severe COVID-19.While neutralizing monoclonal antibodies (mAb) possess considerable efficacy, their current reliance on parenteral dosing necessitates very large doses and places a substantial burden on the healthcare system.In contrast, direct inhaled delivery of mAb therapeutics offers the convenience of self-dosing at home, as well as much more efficient mAb delivery to the respiratory tract.Here, building on our previous discovery of Fc-mucin interactions crosslinking viruses to mucins, we showed that regdanvimab, a potent neutralizing mAb already approved for COVID-19 in several countries around the world, can effectively trap SARS-CoV-2 virus-like-particles in fresh human airway mucus.IN-006, a reformulation of Regdanvimab, was stably nebulized across a wide range of concentrations, with no loss of activity and no formation of aggregates.Finally, nebulized delivery of IN-006 resulted in 100-fold greater mAb levels in the lungs of rats compared to serum, in marked contrast to i.v. dosed mAbs.These results not only support our current efforts to evaluate the safety and efficacy of IN-006 in clin. trials, but more broadly substantiate nebulized delivery of human antiviral mAbs as a new paradigm in treating SARS-CoV-2 and other respiratory pathologies.

News (Medical) associated with Inhalon Biopharma, Inc.

26 Aug 2024

·www.inhalon.com

Inhalon Biopharma Announces Poster Presentation at Military Health System Research Symposium 2024

Session Title: Update in Emerging Infectious Diseases of Military Importance: Predicting and Preventing Future Outbreaks in Military Settings Poster Title: Nebulization Provides Superior Delivery of an Antiviral Monoclonal Antibody Compared to Intravenous Infusion Session Date & Time: August 28, 2024, 10 a.m. Session Title: Update in Emerging Infectious Diseases of Military Importance: Predicting and Preventing Future Outbreaks in Military Settings Poster Title: Development of an Antibody Fusion Protein as a Pan-Variant, Warfighter-Friendly, Decoy Therapeutic to Address Outbreaks with Pandemic Potential Session Date & Time: August 28, 2024, 10 a.m.

Qualified Infectious Disease Product

03 Jun 2024

·www.inhalon.com

Inhalon Biopharma to Provide Update on Inhaled Monoclonal Antibody Therapy Platform at BIO International Convention

Durham, North Carolina, June 3, 2024 — Inhalon Biopharma, a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections (ARI), today announced plans to present at the BIO International Convention being held June 3-6, 2024, in San Diego, Calif. In his presentation, company CEO John Whelan will discuss the company’s recently announced data on the success of inhaled monoclonal antibodies in treating acute respiratory infections, including a Phase 1b study on IN-006, demonstrating the superiority of inhaled antibody delivery over intravenous (IV) or intramuscular (IM) delivery, and preclinical studies published in Advanced Science and Bioengineering and Translational Medicine. “Amid concerns about emerging pathogens like H5N1, and with lessons learned during the recent COVID-19 pandemic fresh in everyone’s minds, there’s a clear sense that the health care ecosystem needs to be able to quickly develop, manufacture and easily deploy effective treatments for respiratory infections,” said John Whelan, chief executive officer of Inhalon Biopharma. “Our inhaled antibody platform is ideal for this application. We’ve repeatedly shown it to be capable of delivering antibodies directly to the site of infection in the respiratory tract, including the deep lung. Further, because this type of treatment can be administered in a patient’s home, it has the potential to address many of logistical challenges that have hindered access to other antibody-based therapies.” Inhalon Biophama is developing inhaled antibody products as potential treatments for a range of acute respiratory infections including respiratory syncytial virus (RSV), SARS-CoV-2, metapneumovirus (hMPV), and influenza. This treatment approach involves the delivery of antibody therapy directly to the site of infection, using a handheld nebulizer rather than systemically via an oral or intravenous delivery approach. Such a treatment approach is believed to reduce costs and ease the burden of care on patients and the health care system. Presentation Details Date: June 3, 2024 Time: 3:15-3:30 p.m. PT Location: Company Presentation Theater 3 About Inhalon Biopharma Inhalon Biopharma is a clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved 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, Life Science Angels, and JSR Life Sciences as well as several federal grants from the NIH and USAMRDC. John Whelan jbwhelan@inhalon.com Media Gwen Gordon gwen@gwengordonpr.com

Phase 1

25 Apr 2024

·www.inhalon.com

Inhalon Biopharma to Share Progress on Inhaled Monoclonal Antibody Therapy at 9th Annual Inhalation and Respiratory Drug Delivery Congress

Back to News Durham, North Carolina, April 25, 2024 — Inhalon Biopharma, a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections (ARI), today announced plans to present at the 9th Annual Inhalation and Respiratory Drug Delivery Congress on April 26, 2024, in London, UK. The presentation, “Pre-clinical and clinical experience with inhaled muco-trapping antibodies against respiratory infections,” will be the keynote address on the “Innovations & novel approaches in inhaled therapies, delivery & device development track.” During the presentation, Inhalon Biopharma founder, chief scientific officer and director Sam Lai, Ph.D., will discuss the company’s progress in advancing its pipeline of inhaled treatments for acute respiratory infections. He will detail recent progress including highlights from a recently completed Phase 1b study comparing inhaled delivery vs. intravenous delivery, and preclinical studies published in Advanced Science and Bioengineering and Translational Medicine. “Since I founded Inhalon Biopharma in 2018, we’ve made tremendous strides towards developing the evidence to support the use of inhaled antibodies to treat respiratory infections,” said Sam Lai, Ph.D., said founder and chief scientific officer of Inhalon Biopharma. “We’ve repeatedly shown in preclinical models, and now in humans, that antibodies can be effectively delivered to the respiratory tract via inhalation, and our studies have upended conventional wisdom about this form of delivery’s ability to reach the deep lung.” Inhalon Biophama is developing inhaled antibody products as potential treatments for respiratory syncytial virus (RSV), SARS-CoV-2, metapneumovirus (hMPV), and influenza. This treatment approach involves the delivery of antibody therapy directly to the site of infection, using a handheld nebulizer rather than systemically via an oral or intravenous delivery approach. Such an approach is believed to reduce costs and ease the burden of care on patients and the health care system. About Inhalon Biopharma Inhalon Biopharma is a clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved 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, Life Science Angels, and JSR Life Sciences as well as several federal grants from the NIH and USAMRDC. John Whelan jbwhelan@inhalon.com Media Gwen Gordon gwen@gwengordonpr.com

Phase 1

100 Deals associated with Inhalon Biopharma, Inc.

100 Translational Medicine associated with Inhalon Biopharma, Inc.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

IN-002 (Inhalon)	Respiratory Syncytial Virus Infections More	Preclinical
IN-007 ( SARS-CoV-2 antigen )	Severe Acute Respiratory Syndrome More	Preclinical
IN-005	Influenza, Human More	Discovery
IN-003 (Inhalon)	Metapneumovirus infection More	Discovery
IN-008	Parainfluenzae virus infection More	Discontinued

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