Key Takeaways

  • Link Biologics completed IND-enabling preclinical studies for LB001, an investigational TSG-6-based eye drop for moderate to severe DED

  • Repeat-dose ocular toxicology studies demonstrated favorable tolerability, a wide safety margin, and minimal systemic exposure

  • An IND submission is planned for Q1 2027, followed by a phase 1/2 clinical trial pending regulatory clearance

Link Biologics has completed its investigational new drug (IND)-enabling preclinical program for LB001 (Link_TSG6), a first-in-class TSG-6-based eye drop being developed for moderate to severe dry eye disease (DED).

The milestone supports the company's planned IND submission in the first quarter of 2027, with a phase 1/2 clinical trial expected to follow pending regulatory clearance.

LB001 is designed to address both inflammation and ocular surface damage associated with DED through a dual anti-inflammatory and tissue-reparative mechanism of action. The investigational therapy is intended to provide an alternative to existing treatments by targeting multiple underlying components of the disease.

The preclinical program included repeat-dose ocular toxicology studies lasting up to 13 weeks. According to the company, the studies demonstrated favorable tolerability, a wide safety margin, and minimal systemic exposure.

Link Biologics also reported progress in manufacturing readiness, completing 2 good manufacturing practice (GMP) production runs to supply the planned phase 1/2 clinical study.

"The completion of our IND-enabling program, supported by favorable safety and tolerability findings and successful GMP manufacturing scale-up, significantly derisks LB001 as we prepare for IND submission," said Reuben Dawkins, chief executive officer and co-founder of Link Biologics.

Mr. Dawkins added that the therapy's ability to target both inflammation and ocular surface damage could address limitations of existing DED treatments.

With preclinical development completed, the company is preparing its IND submission for the first quarter of 2027. If cleared, Link plans to initiate a phase 1/2 study evaluating LB001 in patients with DED.