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AKG-100

Developer(s)

Akagera Medicines

Originator
https://www.akageramedicines.com/

United States of America

Akagera Medicines is a clinical-stage biopharmaceutical company founded in 2018 that develops novel lipid-nanoparticle and liposomal formulations of therapeutics and vaccines to treat infectious diseases such as Lassa Fever, HIV, RSV, and Influenza.

Drug structure

AKG-100 Structure Placeholder

AKG-100 Structure Placeholder

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Mechanism of Action of AKG-100 Liposomal nanoparticle

Mechanism of Action of AKG-100 Liposomal nanoparticle

https://www.akageramedicines.com/test-page-mel/#jump

Drug information

Associated long-acting platforms

Inorganic nanoparticles

Administration route

Intravenous

Therapeutic area(s)

TB
Other(s) : "Gram-positive bacterial infections."

Use case(s)

Treatment
Prevention

Use of drug

Ease of administration

Administered by a community health worker
Administered by a nurse
Administered by a specialty health worker

Frequency of administration

Monthly

User acceptance

Not provided

Dosage

Available dose and strength

Strength: 85mg/10mL; Dose : up to 850 mg (under Phase 1 Multi ascending dose (MAD) investigation)

Maximum dose

850 mg adult dose

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Drug information

Drug's link(s)

Not provided

Generic name

AKG-100

Brand name

Not provided

Compound type

Small molecule

Drug class/category

Oxazolidinone - 50S/70S protein inhibitor

Summary

1. Pharmacology: A highly stabilized, pegylated liposomal IV therapeutic belonging to the oxazolidinone antibiotic class. It delivers toxic payloads directly into target macrophages where Mycobacterium tuberculosis resides. 2. Clinical Pharmacokinetics: The liposomal nanoparticle structure shields the drug from rapid degradation. It provides sustained drug release for atleast 14 days after single dosage with 3.7 log₁₀ reduction in bacterial burden. 3. Safety & Efficacy: Phase 1 single-ascending-dose trials evaluated doses up to 850 mg in 40 healthy volunteers and 15 pulmonary TB patients. It was well-tolerated with zero discontinuations. All adverse events were mild and self-limiting. Early bactericidal activity data confirms robust efficacy against drug-resistant TB strains.

Approval status

AKG-100 is under clinical invesigation at pHase 1 ascending dose trial

Regulatory authorities

AKG-100 is under clinical invesigation at pHase 1 ascending dose trial, not approved yet

Delivery device(s)

Not provided

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Clinical trials

Not provided

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

Description

Oxazolidinone compounds, liposome compositions comprising oxazolidinone compounds and methods of use thereof

Brief description

Compositions and methods for the treatment of tuberculosis, as well as other mycobacterial and gram positive bacterial infections are disclosed. These compositions contain a highly potent and selective oxazolidinone encapsulated with high efficiency to maximize dosing potential of low toxicity drugs, and are stable in the presence of plasma. The compositions are long circulating and retain their encapsulated drug while in the circulation following intravenous dosing to allow for efficient accumulation at the site of the bacterial or mycobacterial infection. The high doses that can be achieved when combined with the long circulating properties and highly stable retention of the drug allow for a reduced frequency of administration when compared to daily or twice daily administrations of other drugs typically utilized to treat these infections.

Representative patent

WO2021258013A1

Category

Drug Formulation

Patent holder

Akagera Medicines Inc

Exclusivity

Not provided

Expiration date

Not provided

Status

Ceased

Supporting material

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

Access principles

Collaborate for development

Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology

Not provided

Share technical information for match-making assessment

Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit

Not provided

Work with MPP to expand access in LMICs

In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing

Not provided

Comment & Information

Not provided