BI 764524 / Boehringer Ingelheim - LARVOL DELTA

The Phase I/IIa HORNBILL study: Investigating BI 764524 in patients with diabetic macular ischemia (ARVO 2023) - P1/2 | "The HORNBILL study is the first to test a drug for people with DMI. The full results should be ready by April 2023."

Clinical • P1/2 data • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Phase 1/2a Trial Investigating the Safety and Preliminary Efficacy of BI 764524 in Patients With Diabetic Macular Ischemia (AAO 2023) - P1/2 | "In the MD part, mean (standard deviation) age was 59.5 (11.4) years, baseline best corrected visual acuity in the study eye was 65.2 (18.6) letters and time since DMI diagnosis was 1.9 (2.4) years. Conclusion HORNBILL is the first study to evaluate a potential treatment for DMI."

Clinical • P1/2 data • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Outcomes of the HORNBILL study: a Phase I/IIa trial investigating BI 764524 in patients with diabetic macular ischemia (ARVO 2024) - P1/2 | "BI 764524 was well tolerated following administration of single and multiple doses. The full results, including assessment of early efficacy, will be presented for the first time at ARVO 2024. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P1/2 data • Diabetic Retinopathy • Ocular Inflammation • Ophthalmology • Retinal Disorders

Final Results and Exploratory Outcomes of the HORNBILL Study: A Phase 1/2a Trial of BI?764524 in Patients With Diabetic Macular Ischemia (AAO 2024) - P1/2 | "Conclusion BI?764524 was well tolerated in patients with DMI and demonstrated early signs of potential efficacy. The CRIMSON Phase 2b trial will study BI 764524 in patients with moderately severe/severe nonproliferative diabetic retinopathy."

Clinical • P1/2 data • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • SEMA3A

Pharmacokinetics (PK) of BI 764524 after intravitreal therapy (IVT) in diabetic macular ischemia (DMI) patients: Insights from the HORNBILL Study (ARVO 2025) - "Previous studies have shown the drug is not harmful and may improve DMI in some patients.This study tested how the drug works in the body, and whether patients receiving it have immune system reactions that may stop it from working. The study had two parts: in the first, three different doses were tested, and in the second, only the highest dose was tested.There did not appear to be any accumulation of the drug in the body over a 4-week interval that could cause negative effects."

Clinical • PK/PD data • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • SEMA3A

Plain language summary of a study testing a new drug (BI 764524) for diabetic macular ischemia. (PubMed, Ther Adv Ophthalmol) - "BI 764524 was injected into the eyes of 33 people with DMI. This paper describes whether there were any safety-related events that might stop BI 764524 being tested in more trials and if it helped people in the trial."

Journal • Cardiovascular • Diabetes • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=188 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Retinopathy • Retinal Disorders

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=187 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Retinopathy • Retinal Disorders

CRIMSON : A multicentre randomised, sham-controlled, double-masked, 72-week trial to study the safety, tolerability, pharmacokinetics, and efficacy of 3 dosing regimens of intravitreal BI 764524 in patients with moderate to severe non-proliferative diabetic retinopathy (PubMed, Ophthalmologie) - No abstract available

Journal • PK/PD data • Diabetic Retinopathy • Retinal Disorders

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Jul 2026 ➔ Apr 2027

Trial primary completion date • Diabetic Retinopathy • Retinal Disorders

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Nov 2026 ➔ Sep 2027

Trial completion date • Diabetic Retinopathy • Retinal Disorders

HORNBILL: A First-in-Human Phase I/IIa Study of the Safety, Tolerability, and Early Pharmacodynamics of BI 764524 for Diabetic Macular Ischemia. (PubMed, Ophthalmol Sci) - "These findings support further investigation of BI 764524 in participants with DR and retinal nonperfusion. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • P1/2 data • PK/PD data • Cardiovascular • Diabetic Macular Edema • Diabetic Retinopathy • Inflammation • Ocular Inflammation • Ophthalmology • Retinal Disorders • Vasculitis • SEMA3A

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Retinopathy • Retinal Disorders

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=175 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P2 trial • Diabetic Retinopathy • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2 | N=45 | Completed | Sponsor: Boehringer Ingelheim | Trial primary completion date: Nov 2022 ➔ Apr 2023

Trial primary completion date • Cardiovascular • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2 | N=45 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed | Trial primary completion date: Apr 2023 ➔ Nov 2022

Trial completion • Trial primary completion date • Cardiovascular • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Jan 2023 ➔ Apr 2023

Trial primary completion date • Cardiovascular • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2023 ➔ Apr 2023

Trial completion date • Cardiovascular • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: a phase I/IIa trial examining the safety, tolerability and early response of BI 764524 in patients with diabetic retinopathy and diabetic macular ischaemia-rationale, study design and protocol. (PubMed, Trials) - P1/2 | "DMI is a poorly defined condition with no treatment options. HORNBILL is the first clinical trial to assess a treatment for DMI and to use OCTA as a means to define and examine DMI. The OCTA data generated in this trial could form the basis of formal diagnostic criteria for DMI. Furthermore, the novel mechanism of action (Sema3A modulation) explored in this trial has the potential to revolutionise the treatment landscape for patients with DMI."

Clinical • Clinical protocol • Journal • P1/2 data • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2022 ➔ Jan 2023 | Trial primary completion date: Oct 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: May 2022 ➔ Oct 2022; Trial primary completion date: May 2022 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

"Boehringer Ingelheim's BI 764524: Emerging Insight and Market Forecast 2021-2030 - https://t.co/guyiBzPH8C https://t.co/qPb6nxko8r" (,@NewsFromBW)

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Diabetic Retinopathy • Gene Therapies • Ischemic stroke • Ophthalmology • Reperfusion Injury • Retinal Disorders

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1/2 trial • Diabetes • Diabetic Retinopathy • Gene Therapies • Ischemic stroke • Ophthalmology • Reperfusion Injury • Retinal Disorders