Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in HBeAg-negative CHB Subjects Under Stable Nucleos(t)Ide Analogue (NA) Treatment

AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.

Start Date05 Jul 2024

Sponsor / Collaborator

Ausper Biopharma Co., Ltd.

CTR20242026 / Active, not recruitingPhase 2

评估AHB-137 注射液用于核苷（酸）类似物治疗的HBeAg 阴性慢性乙型肝炎受试者的有效性和安全性的随机、多中心II 期临床试验

[Translation] A randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of AHB-137 injection in subjects with HBeAg-negative chronic hepatitis B treated with nucleoside (acid) analogs

主要目的：评估AHB-137 在接受核苷（酸）类似物（NAs）治疗的HBeAg阴性慢性乙型肝炎受试者中的有效性。次要目的：评估AHB-137 在接受NAs治疗的HBeAg 阴性慢性乙型肝炎受试者中的安全性、PK、PD、免疫原性和对生活质量的影响。

[Translation]

Primary objective: To evaluate the efficacy of AHB-137 in HBeAg-negative chronic hepatitis B subjects receiving nucleoside (acid) analogs (NAs) therapy. Secondary objective: To evaluate the safety, PK, PD, immunogenicity and effect on quality of life of AHB-137 in HBeAg-negative chronic hepatitis B subjects receiving NAs therapy.

Start Date05 Jul 2024

Sponsor / Collaborator

Ausper Biopharma Co., Ltd.

NCT06115993 / Active, not recruitingPhase 1/2

A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Single Ascending Doses and Multiple Doses of AHB-137 in Healthy Participants and HBeAg-negative CHB Patients Receiving Stable Nucleos(t)Ide Analogues (NAs) Treatment

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept.

Start Date03 Aug 2023

Sponsor / Collaborator

Ausper Biopharma Co., Ltd.

100 Clinical Results associated with AHB-137

100 Translational Medicine associated with AHB-137

100 Patents (Medical) associated with AHB-137

News (Medical) associated with AHB-137

17 Oct 2024

·www.prnewswire.com

AusperBio to Present Ongoing AHB-137 Clinical Data in Late-Breaking Oral Presentation at AASLD 2024

SAN FRANCISCO, Oct. 17, 2024 /PRNewswire/ -- AusperBio Therapeutic, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio), a clinical-stage biotechnology company, today announced that new clinical data from its lead candidate AHB-137, an antisense oligonucleotide ( ASO) therapeutic, will be featured in a late-breaking oral presentation at the 2024 Liver Meeting®, organized by the American Association for the Study of Liver Diseases ( AASLD). The conference will take place from November 15-19, 2024, in San Diego, California. AHB-137 is being developed to achieve a functional cure for chronic hepatitis B. This presentation will showcase key findings from the ongoing clinical trials, highlighting its potential to impact patient outcomes. Oral presentation details are as follows: Title: HBsAg loss and seroconversion in HBeAg-negative chronic hepatitis B subjects on NA therapy after AHB-137 treatment: preliminary data from an ongoing multicenter, randomized, open-label phase IIa study Session: Late Breaking Abstract Parallel Session 2 Session Time: November 18, 2024, 5:00pm – 6:30pm PDT Presentation Time: November 18, 2024, 6:00 pm - 6:15 pm PDT Authors: Yanhua Ding, Xian Yu, Xieer Liang, Hong Ren, Chongyuan Xu, Wen Wang, Zhihong Liu, Yi Yang, Hong Zhang, Jinlin Hou, Shan Zhong, Hong Chen, Yilei Wen, Tingting Lu, Xiao Qiu, Lidan Wang, Di Zhao, Chen Yang, Miao Wang, Chris Yang, Guofeng Cheng, Junqi Niu About AHB-137 AHB-137, a novel unconjugated antisense oligonucleotide ( ASO) developed within AusperBio's proprietary Med-Oligo™ ASO technology platform, was designed to treat chronic hepatitis B for a functional cure. Its compelling preclinical and Phase 1 clinical data was highlighted at the 2023 EASL™ conference and the 2024 EASL™ conference, respectively. This novel dual-mechanism ASO is presently undergoing a Phase 1b trial across multiple international study sites and a concurrent Phase 2 trial in China. Through a global development strategy, AHB-137 is advancing rapidly towards the goal of HBV cure. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on curing chronic hepatitis B infection. The company has developed a proprietary Med-Oligo™ ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligo™ Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For more information, visit Media Contact Email: [email protected] Investor Contact Tel: 650-888-1756 (US) Email: [email protected] SOURCE AusperBio Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Oligonucleotide

17 Oct 2024

·www.biospace.com

AusperBio to Present Ongoing AHB-137 Clinical Data in Late-Breaking Oral Presentation at AASLD 2024

SAN FRANCISCO , Oct. 17, 2024 /PRNewswire/ -- AusperBio Therapeutic, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio ), a clinical-stage biotechnology company, today announced that new clinical data from its lead candidate AHB-137 , an antisense oligonucleotide ( ASO ) therapeutic, will be featured in a late-breaking oral presentation at the 2024 Liver Meeting ® , organized by the American Association for the Study of Liver Diseases ( AASLD ). The conference will take place from November 15-19, 2024 , in San Diego, California . AHB-137 is being developed to achieve a functional cure for chronic hepatitis B. This presentation will showcase key findings from the ongoing clinical trials, highlighting its potential to impact patient outcomes. Oral presentation details are as follows: Title: HBsAg loss and seroconversion in HBeAg-negative chronic hepatitis B subjects on NA therapy after AHB-137 treatment: preliminary data from an ongoing multicenter, randomized, open-label phase IIa study Session : Late Breaking Abstract Parallel Session 2 Session Time: November 18 , 2024, 5:00pm – 6:30pm PDT Presentation Time: November 18 , 2024, 6: 00 pm - 6:15 pm PDT Authors: Yanhua Ding, Xian Yu, Xieer Liang, Hong Ren , Chongyuan Xu , Wen Wang , Zhihong Liu , Yi Yang , Hong Zhang , Jinlin Hou , Shan Zhong , Hong Chen , Yilei Wen , Tingting Lu , Xiao Qiu , Lidan Wang , Di Zhao , Chen Yang , Miao Wang, Chris Yang , Guofeng Cheng , Junqi Niu About AHB-137 AHB-137, a novel unconjugated antisense oligonucleotide ( ASO ) developed within AusperBio’s proprietary Med-Oligo ™ ASO technology platform, was designed to treat chronic hepatitis B for a functional cure. Its compelling preclinical and Phase 1 clinical data was highlighted at the 2023 EASL ™ conference and the 2024 EASL ™ conference, respectively. This novel dual-mechanism ASO is presently undergoing a Phase 1b trial across multiple international study sites and a concurrent Phase 2 trial in China . Through a global development strategy, AHB-137 is advancing rapidly towards the goal of HBV cure. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China , dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on curing chronic hepatitis B infection. The company has developed a proprietary Med-Oligo ™ ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligo ™ Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For more information, visit Media Contact Email: info@ausperbio.com Investor Contact Tel: 650-888-1756 (US) Email: growth@ausperbio.com View original content to download multimedia: SOURCE AusperBio Therapeutics Inc.

Phase 2Oligonucleotide

18 Jul 2024

·www.echemi.com

AusperBio Completes $37 Million Series A Financing

Recently, AusperBio announced that it has successfully completed A Series A funding round of up to $37 million. The financing was led by InnoPinnacle Fund with participation from Yuanbio Venture Capital, Hankang Capital, Qiming Venture Capital, Genesis Capital and many other well-known investors. The news caused widespread concern in the industry. AusperBio is an innovative drug development company with simultaneous operations in the United States and China, focusing on the research of First-in-class and Best-in-class autonomous targeted delivery of small nucleic acid drugs. The company owns the Med-OligoTM technology platform with independent intellectual property rights, mainly focusing on the functional cure of chronic hepatitis B and the targeted therapy of liver diseases. The funds raised in this round will be used to advance Phase II clinical trials of AusperBio's leading hepatitis B cure candidate AHB-137, as well as to explore combination treatment options and optimize manufacturing processes. In addition, the funds will be used to expand the company's other innovative product pipeline. Dr. Guofeng Cheng, co-founder and CEO of AusperBio, said, "The success of this financing once again demonstrates investors' recognition of our research results. We will step up clinical development of AHB-137 and hope that this potential cure will benefit patients around the world as soon as possible." Dr. Yang Chengyong, Co-founder and CSO of AusperBio, said, "We would like to thank our investors for their support and trust. In the future, we will continue to leverage our strengths in oligonucleotide research and development and targeted delivery technology to promote more innovative therapies to benefit patients."

Phase 2Oligonucleotide

100 Deals associated with AHB-137

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Phase 2	CN	Ausper Biopharma Co., Ltd.	05 Jul 2024
Complete atrioventricular block	Phase 2	CN	Ausper Biopharma Co., Ltd.	03 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05717686 \| NCT06115993 (EASL2024) Manual	Phase 1	Hepatitis B	92	AHB-137	bdfkpqopio(tyvhnxnvmc) = None nkrpnwtomo (ccpbrfpnix ) View more	Positive	12 May 2024
NCT06115993 (EASL2024) Manual	Phase 1	Hepatitis B, Chronic	52	AHB-137	givphynjjv(qujxdkslzt) = None mmmspmofyz (vskhmeaysu ) View more	Positive	12 May 2024
				Placebo
AHB-137 (EASL2023)	Not Applicable	Hepatitis B	-	AHB-137	nulzouaour(ahwfwudsgj) = ojfpuddizc mgnvoaddxw (khgdszzvex ) View more	-	21 Jun 2023
				bepirovir?sen (BPV)	nulzouaour(ahwfwudsgj) = mgxcqvpxap mgnvoaddxw (khgdszzvex ) View more

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