Ongoing Projects

HOME > R&D Pipeline > Current status > Ongoing Projects

KDDF-201904-42 Development of HL217 eye drop as global new drug for the treatment of age-related macular degeneration(Others, Chemical) [2019-11-26]

PRINT
Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

- To evaluate the efficacy and safety of HL217 eye drop in administration in treatment naïve AMD patients in France (Phase 2a), based on anti-angiogenetic effect of HL217 indicated by non-clinical studies and safety and tolerability results during phase 1 study in healthy adults.

- Perform additional non-clinical trials to evaluate repeated ocular toxicity, reproductive and developmental toxicity and possibility of additional indications.

- To license out HL217 eye drop to a global pharmaceutical company or to co-develop HL217 eye drop with partners

- To develop the first AMD treatment drug as eye-drop formulation

Unmet Medical Need & Target Patients

- Target patients

AMD (Age-related Macular Degeneration) patient: The proliferation of abnormal fragile blood vessels in the retina is stimulated by VEGF (vascular endothelial growth factor). AMD is one of the main reasons of vision loss in elderly people, if left untreated.

 

- Unmet medical needs

Currently, drugs for AMD are inconvenient to use because they are intraocular injection formulations (Lucentis, Eyelia, and so on). Intraocular injection can cause poor patient compliance and concerns of side-effects such as inflammation and infection. Also, expensive drug costs can be a burden to patients.

Status

- Nonclinical study results showed inhibitory effects of HL217 on angiogenesis factors. Mouse, rat, mini-pig and beagle dog models were used to evaluate anti-angiogenesis effects of HL217

- Nonclinical safety of HL217 was screened by mouse, rat, rabbit, and beagle dog models.

- Phase 1 clinical trials (both SAD and MAD) to evaluate safety, tolerability and pharmacokinetic profile of HL217 eyedrop in healty male volunteers were completed.

- ANSM(French Authority) approved Phase 2a clinical trial application of HL217 to evaluate safety and efficacy of HL217 in the treatment of exudative age-related macular degeneration in treatment naïve patients on April, 2019.

Intellectual Property

- Basic patent has been granted in Korea and other countries.

- Usage patent has been submitted to Korea and other countries and it is now under examination, while it has been granted in some countries.

- Crystal patent has been submitted to Korea and other countries and it is now under examination.

Competitive Advantages

- HL217 can be the first ‘eye drop’ formulation to offer non-invasive and safe administration.

- HL217 can substitute current treatments or be used as co-administrated drug.

Contact & Company Overview

Related Project

Related Project
list
Update to 2013 © KOREA DRUG DEVELOPMENT FUND. ALL RIGHTS RESERVED. QR Code