Link Biologics completes IND-enabling preclinical programme for LB001, a first-in-class novel therapy for dry eye disease
Completion of key IND-enabling activities represents a major development milestone for LB001IND submission remains on
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- 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
LONDON, Nov. 05, 2026 (GLOBE NEWSWIRE) — 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, today 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.
For more information, please contact:
Optimum Strategic Communications
Nick Bastin, Eleanor Cooper, Henry Williams
Tel: +44 20 4604 4016
Email: link@optimumcomms.com
About Link Biologics
Link Biologics is pioneering the development of protein biologics that harness the protective biology of tumour necrosis factor-stimulated gene-6 (TSG-6), with potential across inflammatory and degenerative conditions. Based on its Link module, Link_TSG6 combines anti-inflammatory, tissue-protective and tissue-reparative properties with greater solubility and stability than the full-length protein. The Company is initially focusing on dry eye disease (DED) and other ocular surface disorders.
Its lead asset, LB001, is an eye drop for DED that has completed IND-enabling preclinical studies demonstrating favourable tolerability, a wide safety margin and minimal systemic exposure. In preclinical models of DED, LB001 demonstrated superior reduction of corneal epithelial damage and inflammation compared with the current standard of care. It is expected to enter clinical development in early 2027.
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