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Developed by 
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Supported by 
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Lipovirtide (LP-80)
Developer(s)
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Shanxi Kangbao Biological Product Originator
https://baike.baidu.com/en/item/Shanxi%20Kangbao%20Biological%20Products%20Co.%2C%20Ltd./75561
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Drug structure
Placeholder for Lipovirtide
Drug information
Associated long-acting platforms
Aqueous drug particle suspension, Lipopeptide (fatty acid-conjugated peptide), Monoclonal antibodies and antibody drug conjugates
Administration route
Subcutaneous
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
Frequency of administration
User acceptance
No published patient-reported acceptability data. In macaque studies no significant injection site reactions or systemic toxicity were observed. Human safety data from the completed phase I and phase II studies have not been published; no anti-drug antibodies were detected in rat or macaque studies.
Dosage
Available dose and strength
Investigational. Single-dose phase I evaluated 5, 10, 20, 40, 60 and 80 mg subcutaneously; phase II evaluated 10 mg and 40 mg once weekly and 60 mg once every 2 weeks.
Maximum dose
80 mg (highest single dose evaluated in phase I, NCT04592315)
Recommended dosing regimen
Investigational. No approved regimen. Phase II regimens under evaluation: lipovirtide 10 mg or 40 mg subcutaneously once weekly, or 60 mg once every 2 weeks, each combined with daily oral lamivudine (3TC) plus tenofovir disoproxil fumarate (TDF), compared with daily oral DTG + 3TC + TDF.
Additional comments
Doses listed are taken from trial registry arm descriptions, not from a product label. Preclinical macaque dosing was 3 mg/kg subcutaneously twice weekly.
Dosage link(s)
Not provided
Drug information
Drug's link(s)
Not provided
Generic name
Brand name
Compound type
Drug class/category
Summary
Approval status
Regulatory authorities
Safety
Efficacy
Evidence Summary
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
Manufactured by solid-phase Fmoc peptide synthesis with C-terminal lysine side-chain deprotection for fatty acid conjugation at research scale; GMP scale-up capacity for the clinical product has not been disclosed.
Tentative equipment list for manufacturing
Research-scale synthesis reported: solid-phase peptide synthesiser (Rink amide MBHA resin, Fmoc chemistry); hydrazine/DMF deprotection step for Dde-protected lysine; reverse-phase preparative HPLC for purification; mass spectrometer for characterisation; lyophiliser. Commercial-scale equipment list not reported.
Manufacturing
Chemical synthesis (solid-phase peptide synthesis). Peptides N-terminally acetylated and C-terminally amidated; stearic acid conjugated at a C-terminal lysine side chain following Dde deprotection; purified by RP-HPLC to >95% homogeneity. GMP manufacturing details for the clinical product have not been published.
Specific analytical instrument required for characterization of formulation
RP-HPLC; mass spectrometry; LC-MS/MS for plasma concentration measurement; circular dichroism spectroscopy for alpha-helicity and thermostability.
Clinical trials
KB-LP-80-101
Identifier
NCT04592315
Link
https://clinicaltrials.gov/study/NCT04592315
Phase
Phase I
Status
Completed
Sponsor
Shanxi Kangbao Biological Product Co., Ltd.
More details
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
Purpose
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-01-23
Anticipated Date of Last Follow-up
2026-05-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-05-02
Actual Completion Date
2023-07-11
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: 1. Male or female aged from 18 to 60 (include 18 and 60)； 2. Body mass index (BMI) \[weight (kg)/ height 2(m2)\] is from 18.0 to 26.0（include 18.0 and 26.0），male weight≥50kg，female weight≥45kg； 3. Confirmed HIV-1 infection； 4. HIV viral load ≥ 1000 copies/mL； 5. Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period； 6. Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document. Exclusion Criteria: 1. Patients in the acute infection stage; 2. Confirmed AIDS patients； 3. Patients who have received antiviral therapy and/or
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
46
Allocation
Randomized
Intervention model
Sequential assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Treatment
Key resources
KB-LP-80-102
Identifier
NCT05349968
Link
https://clinicaltrials.gov/study/NCT05349968
Phase
Phase I
Status
Completed
Sponsor
Shanxi Kangbao Biological Product Co., Ltd.
More details
Primary Objectives 1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy Secondary Objectives 1. Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. 2. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy. 3. Evaluation of the immunogenicity of lipovirtide for injection.
Purpose
Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients
Interventions
Intervention 1
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-06-10
Anticipated Date of Last Follow-up
2026-05-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-06-07
Actual Completion Date
2023-09-07
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied populations
Inclusion Criteria: 1. 18\~60 years old (including the critical value), male and female are not limited. 2. Body mass index BMI \[weight (kg)/height2 (m2)\] is 18.0\~28.0 (including the critical value), male weight should be ≥50kg, female weight should be ≥45kg. 3. Diagnosed with HIV-1 infection. 4. Those who did not plan to have children within 2 weeks prior to screening and within 3 months after the end of the trial and who agreed to use effective non-pharmacological contraception during the trial. 5. Subjects should fully understand the purpose, nature and methods of the test and the possible adverse effects and voluntarily participate in this test. Exclusion Criteria: Subjects meeting any of the following criteria will not be allowed to enter the trial 1. The presence of any of the
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
24
Allocation
Randomized
Intervention model
Sequential assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Treatment
Key resources
SXKB-LP-80-201
Identifier
NCT06061536
Link
https://clinicaltrials.gov/study/NCT06061536
Phase
Phase II
Status
Completed
Sponsor
Shanxi Kangbao Biological Product Co., Ltd.
More details
A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before.
Purpose
Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.
Interventions
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-11-02
Anticipated Date of Last Follow-up
2026-05-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-11-29
Actual Completion Date
2025-01-24
Studied populations
Age Cohort
- Adults
- Older Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied populations
Inclusion Criteria: 1. age≥18 years (including the critical value) when signed the informed consent form ,.male or female. 2. Untreated, confirmed HIV-1 infected patients; 3. HIV RNA viral load≥1000 copies/mL； 4. CD4+ T cell counts≥200 cells/mm3； 5. Subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial; 6. Sign informed consent prior to the test and fully understand the purpose, nature, methods, and possible adverse reactions, and be willing to participate in the study. Exclusion Criteria: 1. Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug; 2. Subjects with severe oppor
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
64
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Treatment
Key resources
Excipients
Proprietary excipients used
Not provided
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Not provided
Residual solvents used
Not provided
Patent info
There are either no relevant patents or these were not yet submitted to LAPaL
Supporting material
Publications
There are no publication
Additional documents
No documents were uploaded
Useful links
There are no additional links