• Completion of key IND-enabling activities represents a major development milestone for LB001
• IND submission remains on track for Q1 2027, followed by initiation of a Phase 1/2 clinical study
• Manufacturing scale-up completed, providing supply for planned clinical studies
  
  

Link Biologics (“Link” or “the Company”), the biotech developing first-in-class TSG-6-based therapies that have a unique combination of anti-inflammatory, tissue-protective and tissue-reparative properties, announces the successful completion of its IND-enabling preclinical programme for LB001 (Link_TSG6), its lead asset, for the treatment of moderate to severe dry eye disease (DED).

LB001 is a first-in-class TSG-6-based eye drop designed to address both the inflammation and ocular surface damage that drive DED. Through its dual anti-inflammatory and tissue-reparative mechanism of action, LB001 has the potential to offer a differentiated alternative to the current standard of care.

The IND-enabling preclinical programme includes repeat-dose ocular toxicology studies of up to 13 weeks, which demonstrated favourable tolerability with a wide safety margin and minimal systemic exposure. Link has also advanced its manufacturing readiness and scale-up, completing two GMP runs to supply the planned Phase 1/2 study.

Reuben Dawkins, Chief Executive Officer and Co-Founder of Link Biologics, stated: “The completion of our IND-enabling programme, supported by favourable safety and tolerability findings and successful GMP manufacturing scale-up, significantly derisks LB001 as we prepare for IND submission. By targeting both inflammation and ocular surface damage, LB001 has the potential to address important limitations of existing therapies and improve outcomes for patients living with dry eye disease.”

With the IND-enabling preclinical programme complete, Link is drafting its IND submission, which remains on track for Q1 2027. Following IND clearance, the Company plans to initiate a Phase 1/2 clinical study of LB001 in DED.