A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2

This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

Start Date31 Mar 2023

Sponsor / Collaborator

Huahui Health Ltd.

NCT05713318 / CompletedPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).

Start Date18 Jan 2023

Sponsor / Collaborator

Huahui Health Ltd.

NCT05753878 / CompletedPhase 1

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Immunogenicity of HH-120 Nasal Spray in Healthy Subjects

This is a clinical study evaluating the safety, tolerability, pharmacokinetic (PK) characteristics and immunogenicity of HH-120 nasal spray in healthy subjects. This study is divided into two parts: Part A is of open-label design and mainly aims to assess the local distribution and PK in nasal cavity of HH-120 nasal spray, subjects from 10 cohorts are sequentially enrolled to perform either nasal endoscopic examination or nasal/ nasopharyngeal samples collection at different time points post administration. Part B mainly aims to assess the safety, systematic pharmacokinetic and immunogenicity after multiple dosing of HH-120 nasal spray, subjects are randomly assigned (3:1) to HH-120 and placebo groups.

Start Date08 Nov 2022

Sponsor / Collaborator

Huahui Health Ltd.

100 Clinical Results associated with HH-120

100 Translational Medicine associated with HH-120

100 Patents (Medical) associated with HH-120

Literatures (Medical) associated with HH-120

01 Dec 2023·Journal of medical virology

Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 prevents SARS‐CoV‐2 infection: Two investigator‐initiated postexposure prophylaxis trials

Article

Author: Lei, Cong ; Ni, Jun ; Zhou, Yunao ; Zou, Liangfeng ; Liu, Juan ; Song, Rui ; Li, Wenhui ; Chen, Xiaoyou ; Li, Guangyu ; Zhang, Hongbin ; Liang, Xiao ; Yang, Fang ; Liu, Zhe ; Jin, Ronghua ; Sui, Jianhua ; Mao, Fengfeng ; Guo, Xiaodi ; Li, Baoliang

Abstract:

HH‐120, an IgM‐like angiotensin converting enzyme 2 (ACE2) fusion protein, has been developed as a nasal spray against Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and is currently undergoing human trials. HH‐120 nasal spray was assessed for postexposure prophylaxis (PEP) in two investigator‐initiated (NS01 and NS02) trials with different risk levels of SARS‐CoV‐2 exposure. NS01 enrolled family caregiver participants who had continuous contacts with laboratory‐confirmed index cases; NS02 enrolled participants who had general contacts (Part 1) or close contacts (Part 2) with index cases. The primary endpoints were safety and laboratory‐confirmed and/or symptomatic SARS‐CoV‐2 infection. In NS01 trial (14 participants), the SARS‐CoV‐2 infection rates were 25% in the HH‐120 group and 83.3% in the external control group (relative risk reduction [RRR]: 70.0%). In NS02‐Part 1 (193 participants), the infection rates were 4% (HH‐120) versus 11.3% (placebo), symptomatic infection rates were 0.8% versus 3.5%, hence with a RRR of 64.6% and 77.1%, respectively. In Part 2 (76 participants), the infection rates were 17.1% (HH‐120) versus 30.4% (placebo), symptomatic infection rates were 7.5% versus 27.3%, with a RRR of 43.8% and 72.5%, respectively. No HH‐120‐related serious adverse effects were observed. The HH‐120 nasal spray used as PEP was safe and effective in preventing laboratory‐confirmed and symptomatic SARS‐CoV‐2 infection.

01 May 2023·Journal of medical virology

Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 accelerates SARS‐CoV‐2 clearance: A single‐center propensity score‐matched cohort study

Article

Author: Mao, Fengfeng ; Liu, Zhe ; Sui, Jianhua ; Jin, Ronghua ; Lei, Cong ; Song, Rui ; Zou, Liangfeng ; Chen, Xiaoyou ; Zhang, Hongbin ; Li, Wenhui ; Guo, Xiaodi ; Liang, Xiao ; Li, Baoliang

Abstract:

HH‐120, a recently developed IgM‐like ACE2 fusion protein with broad‐spectrum neutralizing activity against all ACE2‐utilizing coronaviruses, has been developed as a nasal spray for use as an early treatment agent to reduce disease progression and airborne transmission. The objective of this study was to evaluate the safety and efficacy of the HH‐120 nasal spray in SARS‐CoV‐2‐infected subjects. Eligible symptomatic or asymptomatic SARS‐CoV‐2‐infected participants were enrolled in a single‐arm trial to receive the HH‐120 nasal spray for no longer than 6 days or until viral clearance at a single hospital between August 3 and October 7, 2022. An external control was built from real‐world data of SARS‐CoV‐2‐infected subjects contemporaneously hospitalized in the same hospital using a propensity score matching (PSM) method. After PSM, 65 participants in the HH‐120 group and 103 subjects with comparable baseline characteristics in the external control group were identified. The viral clearance time was significantly shorter in participants receiving the HH‐120 nasal spray than that in subjects of the control group (median 8 days vs. 10 days, p < 0.001); the difference was more prominent in those subgroup subjects with higher baseline viral load (median 7.5 days vs. 10.5 days, p < 0.001). The incidence of treatment‐emergent adverse events and treatment‐related adverse events of HH‐120 group were 35.1% (27/77) and 3.9% (3/77), respectively. All the adverse events observed were mild, being of CTCAE grade 1 or 2, and transient. The HH‐120 nasal spray showed a favorable safety profile and promising antiviral efficacy in SARS‐CoV‐2‐infected subjects. The results from this study warrant further assessment of the efficacy and safety of the HH‐120 nasal spray in large‐scale randomized controlled clinical trials.

Nature communicationsQ1 · CROSS-FIELD

An IgM-like inhalable ACE2 fusion protein broadly neutralizes SARS-CoV-2 variants

Q1 · CROSS-FIELD

ArticleOA

Author: Yao, Yuansheng ; Lin, Yongqing ; Huang, Panpan ; Luo, Junmian ; Chen, Jianhe ; Lu, Shuaiyao ; Liu, Chunmei ; Yeung, Man Lung ; Cheng, Yurui ; Liu, Haimo ; Tan, Wenjie ; Qi, Yonghe ; Li, Wenhui ; Ding, Yu ; Peng, Xiaozhong ; Li, Xue ; Sa, Rigai ; Liu, Juan ; Sheng, Yao ; Yuen, Kwok-Yung ; Yu, Guimei ; Song, Rui ; Jin, Ronghua ; Liu, Zibing ; Farzan, Michael ; Yang, Fang ; Tian, Xinxin ; Huang, Baoying ; Chen, Pan ; Li, Guangyu ; Peng, Ran ; Hao, Dongxia ; Fang, Linqiang ; Choe, Hyeryun ; Zheng, Yule ; Liu, Ximing ; Mao, Fengfeng ; Sui, Jianhua ; Sun, Yinyan

Abstract:

Many of the currently available COVID-19 vaccines and therapeutics are not effective against newly emerged SARS-CoV-2 variants. Here, we developed the metallo-enzyme domain of angiotensin converting enzyme 2 (ACE2)—the cellular receptor of SARS-CoV-2—into an IgM-like inhalable molecule (HH-120). HH-120 binds to the SARS-CoV-2 Spike (S) protein with high avidity and confers potent and broad-spectrum neutralization activity against all known SARS-CoV-2 variants of concern. HH-120 was developed as an inhaled formulation that achieves appropriate aerodynamic properties for rodent and monkey respiratory system delivery, and we found that early administration of HH-120 by aerosol inhalation significantly reduced viral loads and lung pathology scores in male golden Syrian hamsters infected by the SARS-CoV-2 ancestral strain (GDPCC-nCoV27) and the Delta variant. Our study presents a meaningful advancement in the inhalation delivery of large biologics like HH-120 (molecular weight (MW) ~ 1000 kDa) and demonstrates that HH-120 can serve as an efficacious, safe, and convenient agent against SARS-CoV-2 variants. Finally, given the known role of ACE2 in viral reception, it is conceivable that HH-120 has the potential to be efficacious against additional emergent coronaviruses.

News (Medical) associated with HH-120

04 Apr 2024

·www.prnewswire.com

Huahui Health to Present Preclinical Data of HH018-sesutecan at the 2024 AACR Annual Meeting

BEIJING, April 4, 2024 /PRNewswire/ -- Huahui Health Ltd.("Huahui Health"), a clinical stage biotechnology company focused on discovering and developing virology, hepatology, and oncology therapies, announced that it will present the results of preclinical data of HH018-sesutecan, a tumor microenvironment targeting CD98-directed ADC, at the American Association for Cancer Research (AACR) Annual Meeting 2024. The AACR meeting will be held April 5–10, 2024, in San Diego, California. Topic: A tumor microenvironment-targeting CD98-directed ADC confers robust anti-tumor activity in multiple cancers with favorable pharmacokinetics and safety profiles in preclinical models Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 4 Session Date and Time: Wednesday Apr 10, 2024 9:00 AM - 12:30 PM Location: Poster Section 54 Poster Board Number: 1 Abstract Presentation Number: LB425 Presenter: Bin Chen, CEO of Huahui Health. Zhu Chen, CSO of ProfoundBio About Huahui Health Huahui Health is a clinical-stage biotechnology company founded in 2015 in Beijing, China. With a focus on virology, hepatology, and oncology, the company is dedicated to drug discovery, development, and antibody engineering. It has expanded its pipeline to include promising drug candidates in virology and oncology, aiming to launch multiple groundbreaking products and lead the way in antiviral and oncology research. Two leading programs have entered the pivotal clinical trial stage. One is HH-003, the first anti-preS1 HBV/HDV neutralizing antibody to enter a pivotal study for chronic HDV infection. The other is HH-120, an IgM-like ACE2-Fc recombinant fusion protein via nasal spray, currently undergoing a phase 3 trial for post-exposure prophylaxis of SARS-CoV-2. For more information, please visit . SOURCE Huahui Health Ltd.

Phase 3AACR

100 Deals associated with HH-120

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	CN	Huahui Health Ltd.	31 Mar 2023
COVID-19 respiratory infection	Phase 1	AU	Huahui Health Ltd.	01 Nov 2021

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