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December 23, 2020

UNITY Biotechnology initiates dosing in diabetic macular edema drug trial

UNITY Biotechnology has dosed the first patient in a Phase I clinical study of drug candidate, UBX1325, in patients with diabetic macular edema (DME).

UNITY Biotechnology has dosed the first patient in a Phase I clinical study of drug candidate, UBX1325, in patients with diabetic macular edema (DME).

The drug candidate is developed from a Bcl-xL inhibiting compound, BM-962, licensed to the company by clinical-stage biotech firm Ascentage Pharma for treating age-related diseases.

The Phase I, first-in-human, open-label, single-ascending dose study will analyse the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME.

It will enrol around 15 patients and the safety and tolerability data is anticipated in the first half of next year.

According to UNITY, UBX1325 led an impact on senescent cells, reduced vascular leakage and improved retinal function in preclinical tests.

In 2016, Ascentage Pharma and UNITY signed a strategic licensing arrangement, authorising UNITY to screen Ascentage Pharma’s Bcl-2 compound library for developing therapies for age-related diseases.

UNITY selected BM-962 from Ascentage Pharma’s library and subject to a licensing deal between the companies.

According to the agreement, Ascentage Pharma retains the rights to the compounds in the Greater China region and intends to establish a joint venture with UNITY for developing and commercialising the compound in China.

The latest move in clinical development qualifies Ascentage Pharma for a milestone payment according to the licensing agreement.

Ascentage Pharma chairman and CEO Dr Dajun Yang said: “Dosing the first patient with UBX1325 marks an important milestone in our collaboration with UNITY.

“We look forward to further progresses by UNITY in its clinical development program. We are confident that our collaboration in developing therapies for age-related diseases will bring fresh hope to patients around the world.”

Earlier this month, Ascentage Pharma initiated a Phase IIa clinical study of its novel APG-115 for treating patients with relapsed/refractory T-cell prolymphocytic leukaemia.

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