Resolute Announces Positive Results from US Phase 1b Trial of Oral Diabetic Macular Edema Treatment 'RZ402'

US Biotech Venture, Largest Shareholder of Handok and Genexine
Study on Increasing Multi-Dose Volume... Safety and Tolerability of Once-Daily Oral Administration Confirmed

[Asia Economy Reporter Lee Gwan-joo] Rezolute, Inc., a US bio-venture company with Handok and Genexine as major shareholders, announced positive key results on the 22nd (local time) for the ‘RZ402’ US Phase 1b multiple ascending dose study (MAD). Based on these results, Rezolute reaffirmed the feasibility of once-daily oral administration of RZ402 and plans to enter Phase 2 clinical trials in the second half of this year.

RZ402, developed by Rezolute, is a plasma kallikrein inhibitor for the treatment of diabetic macular edema. It is being developed as an oral therapy to overcome the limitations of existing injectable drugs. Handok became the largest shareholder by investing in Genexine and Rezolute in 2019 and acquired the commercialization rights for RZ402 in South Korea in 2020.

In the recently completed Phase 1b multiple ascending dose study, RZ402 demonstrated safety and tolerability at higher doses compared to the previous single ascending dose trial. No serious adverse events or drug-related side effects were reported.

Raj Agrawal, Vice President of Rezolute, stated, “RZ402 is an oral therapy that overcomes the limitations of existing injectable drugs and could become a new paradigm in the treatment of diabetic macular edema. In particular, it can help prevent vision loss in patients suffering from diabetic macular edema.”

Rezolute is a US bio-venture developing targeted therapies for rare and metabolic diseases and successfully listed on NASDAQ in 2020. Its main R&D pipelines include RZ358, a treatment for congenital hyperinsulinism, a rare pediatric endocrine disorder, and RZ402, an oral plasma kallikrein inhibitor for diabetic macular edema. Handok holds the commercialization rights for both products in South Korea. Rezolute plans to present the final results of the ongoing RZ402 clinical trials at conferences held this year.

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