{"url":"https://newsforagent.com/news/2026-11-05/link-biologics-lb001-ind-enabling-complete","markdown_url":"https://newsforagent.com/news/2026-11-05/link-biologics-lb001-ind-enabling-complete.md","title":"Link Biologics Completes LB001 Preclinical Work Ahead of 2027 Filing","headline":"Link Biologics Finishes IND-Enabling Work for Dry Eye Drop LB001, Filing Set for Q1 2027","description":"Link Biologics completed IND-enabling preclinical work for its LB001 dry eye drop, with a 13-week toxicology study and two GMP runs done before a Q1 2027 filing.","section":"Research & Clinical Trials","published_at":"2026-11-05T09:00:29+00:00","modified_at":"2026-11-05T09:00:29+00:00","author":"News Desk","key_takeaways":["Link Biologics completed the IND-enabling preclinical programme for LB001, a TSG-6-based eye drop for moderate to severe dry eye disease.","Repeat-dose ocular toxicology studies of up to 13 weeks showed favourable tolerability with a wide safety margin and minimal systemic exposure.","Link Biologics completed two GMP runs to supply the planned Phase 1/2 study and is drafting its IND submission for Q1 2027."],"companies":[{"name":"Link Biologics","is_primary":true,"profile_url":"https://akta.pro/company-profiles/000s1a7/link-biologics","website":"https://linkbiologics.co.uk"}],"source":{"publisher":"GlobeNewswire","title":"Link Biologics completes IND-enabling preclinical programme for LB001, a first-in-class novel therapy for dry eye disease","url":"https://www.globenewswire.com/news-release/2026/11/05/3396099/0/en/link-biologics-completes-ind-enabling-preclinical-programme-for-lb001-a-first-in-class-novel-therapy-for-dry-eye-disease.html"},"other_sources":[{"publisher":"Yahoo","url":"https://finance.yahoo.com/healthcare/articles/spyglass-pharma-sgp-reports-positive-141337996.html"},{"publisher":"Naver","url":"https://n.news.naver.com/mnews/article/018/0006398425"},{"publisher":"Endpoints News","url":"https://endpoints.news/astrazenecas-bruising-summer-raises-the-stakes-for-2027/"}],"tags":["Research & Clinical Trials","Link Biologics"],"body_markdown":"Link Biologics has completed the IND-enabling preclinical programme for LB001, its TSG-6-based eye drop for moderate to severe dry eye disease, and said the IND submission remains on track for the first quarter of 2027. The London-based company announced the milestone on November 5, 2026, according to [GlobeNewswire](https://www.globenewswire.com/news-release/2026/11/05/3396099/0/en/link-biologics-completes-ind-enabling-preclinical-programme-for-lb001-a-first-in-class-novel-therapy-for-dry-eye-disease.html).\n\n## What The LB001 Preclinical Programme Tested\n\n[Link Biologics](https://akta.pro/company-profiles/000s1a7/link-biologics) is a preclinical-stage UK biotech spun out from the University of Manchester in 2021 that develops protein biologics built on TSG-6, or tumour necrosis factor-stimulated gene-6. Its lead asset, LB001, is designed to act on both the inflammation and the ocular surface damage that drive dry eye disease.\n\nThe IND-enabling package included repeat-dose ocular toxicology studies of up to 13 weeks. Those studies showed favourable tolerability with a wide safety margin and minimal systemic exposure, the company said. Link also completed two GMP runs to supply the planned Phase 1/2 study, which it intends to start after IND clearance.\n\nReuben Dawkins, chief executive and co-founder of Link Biologics, said: \"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.\" The company said it is now drafting the IND submission.\n\n## Link Biologics' Théa Partnership And Patent Estate\n\nCompany records show a fully funded partnership valued at more than £200 million with Théa Group for the development and commercialization of the LB001 dry eye programme, according to [akta.pro company records](https://akta.pro/company-data). The same records list a May 2026 USPTO Notice of Allowance for Link_TSG6 in dry eye disease and full assignment of the underlying University of Manchester patent estate, extending US protection to at least 2039. Dry eye disease affects approximately 350 million people worldwide, the records state.\n\n## Dry Eye And Eye Disease Results Elsewhere\n\n[SpyGlass Pharma](https://finance.yahoo.com/healthcare/articles/spyglass-pharma-sgp-reports-positive-141337996.html) reported positive 4-year first-in-human trial data for its Bimatoprost Drug Pad IOL system in open-angle glaucoma and ocular hypertension on October 31, 2026, Yahoo reported. [OliX Pharmaceuticals](https://n.news.naver.com/mnews/article/018/0006398425) resubmitted a New Zealand trial application for OLX301A, a siRNA candidate for macular degeneration, after a rejection over administrative issues, Naver reported on October 28, 2026. [AstraZeneca](https://endpoints.news/astrazenecas-bruising-summer-raises-the-stakes-for-2027)'s Wainua failed a major late-stage heart disease trial in July, Endpoints News reported on October 28, 2026.\n\n## LB001's Next Steps After The Preclinical Work\n\nLink Biologics plans to submit its IND for LB001 in the first quarter of 2027. Following IND clearance, the company intends to begin a Phase 1/2 clinical study of LB001 in dry eye disease.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}