[Translation] Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of LP-005 injection after single and multiple infusions in healthy subjects

主要目的：评价健康受试者单次/多次注射不同剂量LP-005注射液的剂量耐受性和安全性。次要目的：1)评价健康受试者单次/多次注射不同剂量LP-005注射液的药代动力学特征； 2)评价健康受试者单次/多次注射不同剂量LP-005注射液的免疫原性； 3)评价健康受试者单次/多次注射不同剂量LP-005注射液的药效学特征。探索性目的：探索健康受试者单次及多次注射不同剂量LP-005注射液后的PK/PD相关性。

[Translation]

Primary objective: To evaluate the dose tolerance and safety of single/multiple injections of different doses of LP-005 injection in healthy subjects. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of single/multiple injections of different doses of LP-005 injection in healthy subjects; 2) To evaluate the immunogenicity of single/multiple injections of different doses of LP-005 injection in healthy subjects; 3) To evaluate the pharmacodynamic characteristics of single/multiple injections of different doses of LP-005 injection in healthy subjects. Exploratory objective: To explore the PK/PD correlation after single and multiple injections of different doses of LP-005 injection in healthy subjects.

Start Date-

Sponsor / Collaborator

Tianchen Biomedical (Suzhou) Co., Ltd.

CTR20242478 / Not yet recruitingPhase 2

评价LP-005注射液治疗阵发性睡眠性血红蛋白尿症患者的有效性、安全性和药代动力学特征的多中心、随机、开放的Ⅱ期临床研究

[Translation] A multicenter, randomized, open-label Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of LP-005 injection in the treatment of patients with paroxysmal nocturnal hemoglobinuria

主要目的：评价LP-005注射液治疗阵发性睡眠性血红蛋白尿症患者的疗效。次要目的：评价LP-005注射液治疗阵发性睡眠性血红蛋白尿症患者的有效性和安全性；评价LP-005注射液治疗阵发性睡眠性血红蛋白尿症患者的药代动力学、药效学、免疫原性。

[Translation]

Primary objective: To evaluate the efficacy of LP-005 injection in the treatment of patients with paroxysmal nocturnal hemoglobinuria. Secondary objective: To evaluate the efficacy and safety of LP-005 injection in the treatment of patients with paroxysmal nocturnal hemoglobinuria; To evaluate the pharmacokinetics, pharmacodynamics, and immunogenicity of LP-005 injection in the treatment of patients with paroxysmal nocturnal hemoglobinuria.

Start Date-

Sponsor / Collaborator

Tianchen Biomedical (Suzhou) Co., Ltd.

NCT06294301 / RecruitingPhase 1

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).

Start Date19 Nov 2023

Sponsor / Collaborator

Tianchen Biomedical (Suzhou) Co., Ltd.

100 Clinical Results associated with LP-005

100 Translational Medicine associated with LP-005

100 Patents (Medical) associated with LP-005

Literatures (Medical) associated with LP-005

13 Dec 2023·Journal of Agricultural and Food Chemistry

Walnut-Derived Peptide Improves Cognitive Impairment in Colitis Mice Induced by Dextran Sodium Sulfate via the Microbiota–Gut–Brain Axis (MGBA)

Article

Author: Wang, Xuehang ; Wang, Ji ; Wang, Xiyan ; Liu, Xiaoting ; Wu, Dan ; Min, Weihong ; Qi, Yuan ; Leng, Yue ; Zhang, Yaoxin

In this study, we investigated the protective mechanism of walnut-derived peptide LPLLR (LP-5) against cognitive impairment induced in a dextran sodium sulfate (DSS)-induced colitis mouse model, with emphasis on the microbiota-gut-brain axis (MGBA). The results revealed that LP-5 could improve the learning ability and memory of mice with cognitive impairment and mitigate colitis symptoms, including weight loss, bloody stools, colon shortening, and histopathological changes. Additionally, LP-5 protected the integrity of the intestinal barrier by promoting the expression of tight junction proteins (TJs) while attenuating colonic inflammation by suppressing proinflammatory cytokine and epithelial cell apoptosis. Western blotting indicated that LP-5 treatment suppressed the inflammatory NF-κB/MLCK/MLC signaling pathway activity. Furthermore, LP-5 ameliorated hippocampal neuron damage and protected blood-brain barrier (BBB) integrity by downregulating microglia marker protein Iba-1, increasing TJ protein expression, and restoring the deterioration of synaptic proteins. Importantly, 16S rRNA sequencing results indicated that LP-5 reshaped the abundance of a wide range of gut microbiota at the phylum and genus levels, with increased Prevotella and Akkermansia associated with tryptophan (TRP), 5-hydroxytryptamine (5-HT), and 5-hydroxyindoleacetic acid (5-HIAA). These findings suggest that LP-5 could maintain intestinal barrier and BBB integrity, reverse gut dysbiosis, and improve learning and memory ability in colitis mice, providing novel insights into alterations of gut microbes in colitis and a potential new mechanism by which it causes cognitive impairment.

02 Dec 2020·Journal of Agricultural and Food ChemistryQ1 · AGRICULTURAL & FORESTRY SCIENCE

Novel Pentapeptide Derived from Chicken by-Product Ameliorates DSS-Induced Colitis by Enhancing Intestinal Barrier Function via AhR-Induced Src Inactivation

Q1 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Liu, Jihua ; Dai, Wenling ; Ma, Bin ; Wang, Jin ; Li, Shanshan ; Peng, Hengying ; Zheng, Meng

Managing patients with refractory inflammatory bowel diseases (IBD) is a common clinical challenge. Galli Gigeriae Endothelium Corneum (GGEC), a chicken by-product, has been used for centuries in Asian countries as a functional food and supplement for the treatment of gastrointestinal disorders. In this study, a novel peptide (LNLYP, LP-5) with gastrointestinal stability that can enhance the intestinal barrier function that was first identified in GGEC. Our work demonstrated that aryl hydrocarbon receptor (AhR) activation by LP-5 could inhibit the Src kinase to increase tight junction protein levels and down-regulate the expression of inflammatory cytokines to protect the intestinal barrier and finally alleviate dextran sulfate sodium (DSS)-induced colitis. This study revealed that LP-5 had the potential to develop into a therapeutic agent for the treatment of colitis and provided new high-valued utilization of GGEC.

01 Feb 1987·The Journal of NutritionQ2 · MEDICINE

Iodothyronine 5′-Deiodination in Rats Fed Low Protein Diets: Lack of Correlation with Energy Balance

Q2 · MEDICINE

Article

Author: F B Hillgartner ; D R Romsos

Rats fed low protein diets often exhibit an elevation in adaptive thermogenesis that may result in part from activation of thyroid hormone action at the level of peripheral deiodination of thyroxine (T4) to 3,5,3'-triiodothyronine (T3). This possibility was examined by comparing the kinetic parameters of iodothyronine 5'-deiodination in hepatic and renal microsomes and the efficiency of energy retention in weanling rats fed diets containing 5% (LP-5), 8% (LP-8) or 22% (NP) casein. Energy balance measurements revealed that efficiency of energy retention was reduced in rats fed LP-5, whereas no significant change in adaptive thermogenesis was observed in rats fed LP-8. In the LP-5 group the maximal activity of hepatic 5'-deiodinase per milligram of microsomal protein was not different from that of the NP group; however, the Vmax of the renal enzyme was 21% higher. In both tissues, the Km of the reaction was not affected by dietary treatment. Hepatic and renal 5'-deiodination in rats fed LP-8 was similar to that in rats fed LP-5. When compared to corresponding NP controls, each of the low protein dietary groups (LP-5, LP-8) had a higher serum total T3 concentration, whereas serum free T3 and total T4 concentrations were unaffected by the dietary treatments. The findings demonstrate that iodothyronine 5'-deiodination and circulating thyroid hormone concentrations vary in a similar manner in LP-5 and LP-8 animals even though these two groups exhibit different responses in energy efficiency relative to NP controls.(ABSTRACT TRUNCATED AT 250 WORDS)

News (Medical) associated with LP-005

07 Oct 2024

·www.biospace.com

Cognito Therapeutics to Present New Data for Spectris™ in Alzheimer’s Disease at CTAD 2024

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- #alzheimers -- Cognito Therapeutics , a neurotechnology company advancing disease-modifying therapies to treat CNS diseases, announced today it has been selected to present multiple poster presentations for its disease-modifying therapy Spectris™ in patients with Alzheimer’s Disease, at the 17 th Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place in Madrid, Spain, and online, October 29 – November 1, 2024. “We’re excited to present this new clinical data at CTAD, which demonstrates the potential of Spectris™ to preserve both brain function and structure in Alzheimer’s disease patients,” said Christian Howell, CEO of Cognito Therapeutics. “Our recruitment strategies for the HOPE trial have enabled us to evaluate a diverse and representative Alzheimer’s population, and we remain focused on advancing our novel, non-invasive disease-modifying therapy for Alzheimer’s patients.” “Spectris™ has shown promising results in targeting Alzheimer’s disease through non-invasive auditory and visual neuromodulation, with data revealing clinically meaningful outcomes and consistent preservation of daily function and brain structure,” added Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “The HOPE study is designed to enroll a diverse group of participants that more closely reflects the real-world Alzheimer’s disease population. We’re excited to present this new data at CTAD.” Details of the poster presentations are as follows: Abstract Title: SPECTRIS™ Treatment Reduced Alzheimer’s Disease Dependence Score in OVERTURE I/II Phase 2 Study Format: Poster 025 Presenter: Marwan Sabbagh, MD, Barrow Neurological Institute Session Name: Poster Session 1 Date/Time: Tue Oct 29 at 3:00 pm - Wed Oct 30 at 5 pm Abstract Title: SPECTRIS™ OVERTURE I responder analysis demonstrates consistent preservation of function and brain structure. Number: Poster 026 Presenter: Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics Session Name: Poster Session 1 Date/Time: Tue Oct 29 at 3:00 pm - Wed Oct 30 at 5 pm Abstract Title: Clinical Trial Enrichment Strategy for Participant Selection in the Phase 3 HOPE study of Alzheimer’s disease: Progress towards personalized medicine Poster Number: LP005 Presenter: Lily Lee, Ph.D., Vice President and Head of Medical Affairs, Cognito Therapeutics Session Name: Poster Session 1 Date/Time: Tue Oct 29 at 3:00 pm - Wed Oct 30 at 5 pm Abstract Title: Diversity amongst the Phase 3 HOPE study participants is reflective of the real-world Alzheimer’s Disease (AD) population Poster Number: LP 099 Presenter: Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics Session Name: Poster Session 3 Date/Time: Fri Nov 1 at 7:15 am - 5 pm Abstract Title: Comparison of visually evoked steady-state oscillations between two Spectris™ eyesets Poster Number: LP 028 Presenter: Mihaly Hajos, Ph.D., Chief Science Officer, Cognito Therapeutics Session Name: Poster Session 1 Session Date and Time: Tue Oct 29 at 3:00 pm - Wed Oct 30 at 5 pm Abstract Title: Effects of sensory-evoked gamma oscillation on neurophysiological signals of visual and cognitive processing in Alzheimer’s disease Poster Number: LP 016 Presenter: Mihaly Hajos, Ph.D., Chief Science Officer, Cognito Therapeutics Session Name: Poster Session 1 Date/Time: Tue Oct 29 at 3:00 pm - Wed Oct 30 at 5 pm For more information about the HOPE study, visit . About Cognito Therapeutics Cognito Therapeutics is a late-stage clinical neurotechnology company pioneering disease-modifying treatments for neurodegenerative diseases. Its lead product, Spectris™, uses non-invasive auditory and visual neuromodulation to enhance gamma frequency brain activity, with the goal of slowing brain atrophy and functional decline in Alzheimer’s disease. Cognito is committed to developing transformative, technology-driven interventions to address unmet needs in the treatment of CNS diseases. Cognito is headquartered in Cambridge, MA. For more information, visit . Contacts Media Contact: Kimberly Ha KKH Advisors 917-291-5744 kimberly.ha@kkhadvisors.com

Phase 3

24 Sep 2024

·www.prnewswire.com

LongBio announced the completion of Series B2 financing, led by Qiming Venture Partners

SHANGHAI, Sept. 24, 2024 /PRNewswire/ -- LongBio Pharma (Suzhou) Co., Ltd. ("LongBio" or the "Company"), a Phase III-stage biotech company focused on the R&D of innovative antibody and fusion protein drugs for allergies and complement-mediated diseases, announced the completion of its Series B2 financing round, raising tens of millions of RMB. The round was led by Qiming Venture Partners, with continued support from existing investors. The funds will primarily be used to advance late-stage clinical studies in the company's pipeline, strengthen team capabilities, and bolster working capital. Leveraging its proprietary technology platform, LongBio has developed a range of innovative biologics with independent intellectual property rights. LP-003, a best-in-class, high-affinity anti-IgE antibody, has demonstrated the potential for superior efficacy, lower dosing, longer dosing intervals, and greater cost-effectiveness. Existing data indicates that: LP-003 can extend the dosing frequency of current drugs targeting the same target from once every 2-4 weeks to once every 3-6 months. 100 mg of LP-003 showed comparable efficacy to 300 mg of omalizumab. Subgroup analysis in Phase II study further revealed that LP-003 may offer superior efficacy compared to omalizumab under similar pollen density conditions. LongBio has also initiated clinical studies in China for LP-003 in various other indications, including chronic spontaneous urticaria (CSU), asthma, and food allergy. The company aims to present the topline results of the LP-003 Phase II study for CSU, using omalizumab as a positive control, at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) meeting in San Diego, US, in February 2025. The US FDA IND filing for CSU and food allergy is currently in preparation, and will be submitted later this year. LP-005, a potential first-in-class bi-functional anti-C3&C5 antibody, has entered Phase II clinical trials for paroxysmal nocturnal hemoglobinuria (PNH) in China. By fully inhibiting all three pathways of the complement system, LP-005 may offer superior efficacy in diseases involving multiple pathways compared to other complement drugs that target only one. LongBio is also exploring LP-005 as a potential treatment for complement-mediated nephritis, eye diseases, and neurological disorders. For more information, please visit or contact [email protected] About Qiming Venture Partners Qiming Venture Partners was founded in 2006. Currently, Qiming Venture Partners manages eleven US Dollar funds and seven RMB funds with $9.5 billion in capital raised. Since our establishment, we have invested in outstanding companies in the Technology and Consumer (T&C) and Healthcare industries at the early and growth stages. Since our debut, we have backed over 530 fast-growing and innovative companies. Over 200 of our portfolio companies have achieved exits through IPOs at the NYSE, NASDAQ, HKEX, Shanghai Stock Exchange, or Shenzhen Stock Exchange, or through M&A or other means. There are also over 70 portfolio companies that have achieved unicorn or super unicorn status. SOURCE LongBio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical Result

15 Apr 2024

·www.prnewswire.com

Pre-clinical result of LP-005, a novel bi-functional complement antibody-fusion protein was unveiled by LongBio at WCN2024

BUENOS AIRES, Argentina, April 15, 2024 /PRNewswire/ -- LongBio Pharma (Suzhou) Co., Ltd. (referred to as "LongBio"), a leading biotech company dedicated to developing innovative protein treatments for nephrology, allergy, respiratory, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of pre-clinical data of LP-005, a novel bi-functional complement antibody-fusion protein, at the 2024 World Congress of Nephrology (WCN24) held by International Society of Nephrology (ISN). The poster titled "Bi-functional C5 antibody-fusion protein (LP-005) with potential best-in-class bioactivity for complement inhibition" was presented by LongBio during the conference. Date and Time: April 15, 2024, at 17:45 pm (UTC -3) Location : Exhibition Hall and Main Foyer Poster Number: MON-100 Methods: Eculizumab, POT-4 (also known as APL-1) was purchased from vendors. The sequences of Ravulizumab, Crovalimab, Pozelimab, Narsoplimab and Ab-fH were obtained from INN and made in-house with LP-005, LP-005C. CP, AP, LP and C3b deposition assays with head-to-head comparison were conducted. Monkey PK/PD assay of LP-005C and Ab-fH was also conducted. Results: LP-005 shows the most potent inhibition in CP, AP and LP compared to Eculizumab, Ravulizumab, Crovalimab, Pozelimab and Narsoplimab. In addition, it also has the most efficient inhibition in C3b assay compared to Antibody-fH fusion and POT-4 (APL-1). The monkey PK/PD study indicates that when fusing to the same C5 antibody, LongBio's unique inhibitor (inCibitorTM) shows a better PK/PD profile compared to the natural fH 1-5 fragment. LP-005 is a novel bifunctional complement antibody fusion protein targeting both C3 and C5, with better bioactivity in CP, AP, LP and C3b deposition assays. Meanwhile, LP-005 is engineered to optimize surface charge (PI) and FcRn binding, making it first Q4W bi-functional complement inhibitor all over the world. With all these advantages above, LP-005 has the potential to be a best-in-class drug candidate with excellent and full complement inhibitory activity and will be explored in complement mediated disorders. LP-005's phase I study in healthy volunteers will be completed in 2024Q2 in China. At present, LP-005 showed expected PK/PD profile and well tolerated safety profile. More clinical data will be unveiled at 2024 European Meeting on Complement in Human Diseases in September. The phase II studies with indication of IgAN (IgA Nephropathy) and PNH (Paroxysmal nocturnal hemoglobinuria, rare disease) will initial in 2024Q2. Other indications in neurology and ophthalmology are also scheduled to develop. About InCibitor™ InCibitorTM is a new generation of complement inhibitor platform developed by LongBio. The bi-functional complement inhibitor LP-005 developed based on this platform is going to start Phase II study of IgAN and PNH. LongBio is also exploring the development of new drugs related to hematology, nephrology, neurology, ophthalmology, oncology, and gene therapy based on this platform. About LongBio LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare diseases, serving patients and society. LongBio Pharma aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is about to start Phase III study in 2024Q2, and prepare for BLA in 2025H1. The second leading pipeline is a bi-functional complement antibody fusion-protein (LP-005) , which is in Phase I at present, intending to start Phase II/III in 2024Q2. For more information, please visit: or please contact: [email protected]. SOURCE LongBio

Phase 1Phase 2Clinical ResultGene Therapy

100 Deals associated with LP-005

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemoglobinuria, Paroxysmal	Phase 2	CN	Tianchen Biomedical (Suzhou) Co., Ltd.	22 Jul 2024
Peripheral Nervous System Diseases	IND Approval	CN	Tianchen Biomedical (Suzhou) Co., Ltd.	06 Mar 2024
C3 glomerulopathy	IND Approval	CN	Tianchen Biomedical (Suzhou) Co., Ltd.	05 Mar 2024
Glomerulonephritis, IGA	IND Approval	CN	Tianchen Biomedical (Suzhou) Co., Ltd.	05 Mar 2024
Amyotrophic Lateral Sclerosis	IND Approval	CN	Tianchen Biomedical (Suzhou) Co., Ltd.	01 Mar 2024
Myasthenia Gravis	IND Approval	CN	Tianchen Biomedical (Suzhou) Co., Ltd.	18 Jul 2023
Age Related Macular Degeneration	Preclinical	-	Tianchen Biomedical (Suzhou) Co., Ltd.	19 Jun 2023
Hematologic Diseases	Preclinical	-	Tianchen Biomedical (Suzhou) Co., Ltd.	19 Jun 2023
Nephrosis	Preclinical	-	Tianchen Biomedical (Suzhou) Co., Ltd.	19 Jun 2023
Dystrophy, Macular	Preclinical	CN	Al Health Eye Medicine (Liaoning) Co., Ltd.	-

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