Belite Bio has completed enrolment in the 24-month PHOENIX Phase III trial assessing the tolerability and safety of oral Tinlarebant in individuals with geographic atrophy (GA) in dry age-related macular degeneration (AMD).
This multicentre, randomised, placebo-controlled, double-masked, global trial is crucial in evaluating the therapy’s potential to minimise the atrophic lesion growth rate in these patients.
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It has enrolled 500 participants across various sites in the US, the UK, the Czech Republic, France, Switzerland, Taiwan, Australia, and China.
Tinlarebant, a one-daily tablet, is being developed as an early intervention to preserve retinal tissue health and integrity in those with Stargardt disease type 1 (STGD1) and GA.
At present, there are no treatments approved by the Food and Drug Administration (FDA) for STGD1 and no approved oral treatments for GA.
The tablet has received fast track, rare paediatric disease, and breakthrough therapy designations in the US, orphan drug status in the US, Japan, and Europe, and Sakigake designation in Japan for STGD1.
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By GlobalDataTinlarebant is also being evaluated in a Phase III trial (DRAGON) and a Phase II/III trial (DRAGON II) for adolescent STGD1 individuals, in addition to the PHOENIX trial for GA subjects.
Belite Bio CEO and chairman Dr Tom Lin said: “Completing enrolment in the PHOENIX trial marks an important milestone for Belite Bio as we advance our lead candidate, Tinlarebant, for the treatment of geographic atrophy.
“This achievement brings us one step closer to evaluating the potential of Tinlarebant to slow atrophic lesion growth in this serious and progressive disease for which there are no approved oral treatments. There remains a significant unmet need for this patient population.”
The company develops new treatments for degenerative retinal diseases like STGD1 and GA.
Last year, the company submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to initiate a trial of Tinlarebant for adolescent STGD1 treatment.
