IgA nephropathy is an autoimmune disease that damages the kidneys. Credit: Robina Weermeijer on Unsplash.

Kira Pharmaceuticals has received clearances in China and Australia to commence Phase II clinical trials of investigational bifunctional biologic, KP104, for IgA nephropathy (IgAN) and complement 3 glomerulopathy (C3G).

The Chinese National Medical Products Administration (NMPA) and the Australian Therapeutic Goods Administration (TGA) granted the approval.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The trials will assess the safety, efficacy, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KP104 in IgAN and C3G patients in China and Australia. 

Created to hinder the alternative and terminal complement pathways at the same time, KP104 has a dual-target mechanism of action.

Kira CEO Frederick Beddingfield said: “These clearances add to the multiple INDs Kira has secured this year for KP104 and mark our first in IgAN and C3G, serious immune-mediated conditions that cause kidney damage and often result in kidney failure. 

“We believe that KP104’s ability to simultaneously and synergistically block two key complement targets makes it a unique therapeutic option with the potential to make a profound impact on the lives of patients living with these kidney diseases around the world.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to the findings from the Phase I SYNERGY-1 trial, KP104 showed clinical proof of mechanism.

Earlier this year, the US Food and Drug Administration (FDA) granted Orphan Drug Designation for the biologic to treat paroxysmal nocturnal haemoglobinuria (PNH). 

At present, KP104 is being analysed in a Phase II study in PNH and the company has plans to analyse it for various haematology and nephrology indications.

An autoimmune ailment, IgAN damages the kidneys while C3G comprises dense deposit disease and C3 glomerulonephritis, which leads to glomeruli inflammation and damage in the kidney.