Pipeline

Our pipeline is focused on developing itolizumab as a potentially first-in-class treatment for multiple severe immuno-inflammatory disorders, including graft-versus-host disease, uncontrolled moderate to severe asthma and SLE / lupus nephritis.

Transplant Science

Phase 1

Phase 1b / 2

Phase 3

COVID-19

Biocon has received EUA in India

Positive FDA response to Pre-IND briefing package; if successful may suffice for BLA filing

IND submission pending for global DBPC study

  • Phase 2 Study Completed by Biocon in India
Completed by Biocon in India

IND open

Transplant Science

EQUATE Phase 1b/2 trial actively enrolling

Positive interim data announced

  • Phase 1b/2
FDA Fast Track and
Orphan Drug Designation

Renal Disease

EQUALISE Phase 1b trial actively enrolling

  • Phase 1b
FDA Fast Track Designation

Pulmonary

EQUIP Phase 1b trial actively enrolling

  • Phase 1b

Indication

Delivery

Phase 1

Phase 2

Phase 3

Status, Designations & Catalysts

Transplant Science

  • Phase 3
Pivotal study
initiation expected
Q4 2021
  • Pivotal Phase 3 study to support BLA filing
  • FDA FastTrack and Orphan Drug Designations

Renal Disease

  • Phase 1
  • EQUALISE Phase 1b trial actively enrolling
  • FDA FastTrack Designation
  • LN interim data expected 2H 2021

Pulmonary

  • Phase 1
  • EQUIP Phase 1b trial actively enrolling
  • Topline data expected 2H 2021

Biocon completed a Phase 1 study in healthy volunteers in Australia.