Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy
Belite Bio (NASDAQ: BLTE) has announced the completion of enrollment in its pivotal global Phase 3 PHOENIX trial evaluating Tinlarebant for geographic atrophy (GA) in dry age-related macular degeneration (AMD). The trial has successfully enrolled 500 subjects across multiple countries including the United States, United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia.
The 24-month, randomized, double-masked, placebo-controlled, multicenter study aims to evaluate the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in GA patients. The United States led enrollment numbers, highlighting strong interest in the oral treatment option compared to existing invasive alternatives.
This milestone is particularly significant as there are currently no approved oral treatments for GA, which is an advanced stage of dry AMD causing progressive vision loss through expanding lesions in the retina. The company plans to share interim results at the trial's midpoint.
Belite Bio (NASDAQ: BLTE) ha annunciato il completamento dell'arruolamento nel suo studio globale di Fase 3 PHOENIX, fondamentale per valutare Tinlarebant nella atrofia geografica (GA) legata alla degenerazione maculare secca legata all'età (AMD). Lo studio ha arruolato con successo 500 soggetti in diversi paesi, tra cui Stati Uniti, Regno Unito, Francia, Repubblica Ceca, Svizzera, Cina, Taiwan e Australia.
Lo studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, della durata di 24 mesi mira a valutare la sicurezza e la tollerabilità di Tinlarebant e la sua capacità di ridurre il tasso di crescita delle lesioni atrofiche nei pazienti con GA. Gli Stati Uniti hanno guidato i numeri di arruolamento, evidenziando un forte interesse per questa opzione di trattamento orale rispetto alle alternative invasive attualmente disponibili.
Questo traguardo è particolarmente rilevante poiché attualmente non esistono trattamenti orali approvati per la GA, una fase avanzata della AMD secca che provoca una progressiva perdita della vista a causa dell'espansione delle lesioni nella retina. L'azienda prevede di condividere i risultati intermedi a metà dello studio.
Belite Bio (NASDAQ: BLTE) ha anunciado la finalización de la inscripción en su ensayo global pivotal de Fase 3 PHOENIX, que evalúa Tinlarebant para la atrofia geográfica (GA) en la degeneración macular seca relacionada con la edad (AMD). El ensayo ha logrado inscribir con éxito a 500 sujetos en varios países, incluidos Estados Unidos, Reino Unido, Francia, República Checa, Suiza, China, Taiwán y Australia.
El estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 24 meses tiene como objetivo evaluar la seguridad y tolerabilidad de Tinlarebant y su potencial para reducir la tasa de crecimiento de las lesiones atróficas en pacientes con GA. Estados Unidos lideró el número de inscripciones, destacando un fuerte interés en esta opción de tratamiento oral frente a las alternativas invasivas existentes.
Este hito es especialmente significativo ya que actualmente no existen tratamientos orales aprobados para GA, una etapa avanzada de AMD seca que causa pérdida progresiva de la visión debido a la expansión de lesiones en la retina. La compañía planea compartir resultados intermedios a mitad del ensayo.
Belite Bio (NASDAQ: BLTE)는 건성 노인성 황반변성(AMD)의 지리적 위축(GA) 치료를 위한 Tinlarebant의 글로벌 3상 PHOENIX 임상시험 등록 완료를 발표했습니다. 이 임상시험은 미국, 영국, 프랑스, 체코, 스위스, 중국, 대만, 호주 등 여러 국가에서 500명의 대상자를 성공적으로 등록했습니다.
24개월 동안 진행되는 무작위 배정, 이중 눈가림, 위약 대조, 다기관 연구로 Tinlarebant의 안전성과 내약성, 그리고 GA 환자의 위축 병변 성장률 감소 가능성을 평가하는 것이 목적입니다. 미국이 등록 수를 주도하며 기존의 침습적 치료법에 비해 경구용 치료제에 대한 높은 관심을 보여주었습니다.
현재 GA에 대해 승인된 경구 치료제가 전무한 상황에서 이번 성과는 매우 중요합니다. GA는 건성 AMD의 진행된 단계로 망막 내 병변 확장을 통해 시력 손실이 점진적으로 발생합니다. 회사는 임상시험 중간 시점에 중간 결과를 발표할 계획입니다.
Belite Bio (NASDAQ : BLTE) a annoncé avoir terminé le recrutement de son essai mondial pivotal de Phase 3 PHOENIX, évaluant Tinlarebant pour l'atrophie géographique (GA) dans la dégénérescence maculaire sèche liée à l'âge (DMLA). L'essai a réussi à recruter 500 sujets dans plusieurs pays, dont les États-Unis, le Royaume-Uni, la France, la République tchèque, la Suisse, la Chine, Taïwan et l'Australie.
Cette étude multicentrique, randomisée, en double aveugle, contrôlée par placebo, d'une durée de 24 mois vise à évaluer la sécurité et la tolérabilité de Tinlarebant ainsi que son potentiel à réduire le taux de croissance des lésions atrophiques chez les patients atteints de GA. Les États-Unis ont mené les chiffres d'inscription, soulignant un fort intérêt pour cette option de traitement oral par rapport aux alternatives invasives existantes.
Cette étape est particulièrement importante car il n'existe actuellement aucun traitement oral approuvé pour la GA, une phase avancée de la DMLA sèche provoquant une perte progressive de la vision due à l'expansion des lésions dans la rétine. La société prévoit de partager les résultats intermédiaires à mi-parcours de l'essai.
Belite Bio (NASDAQ: BLTE) hat den Abschluss der Einschreibung in seine wegweisende globale Phase-3-Studie PHOENIX bekannt gegeben, in der Tinlarebant bei geografischer Atrophie (GA) der trockenen altersbedingten Makuladegeneration (AMD) geprüft wird. Die Studie hat erfolgreich 500 Probanden aus mehreren Ländern, darunter die USA, Großbritannien, Frankreich, Tschechien, die Schweiz, China, Taiwan und Australien, eingeschlossen.
Die 24-monatige, randomisierte, doppelblinde, placebokontrollierte, multizentrische Studie zielt darauf ab, die Sicherheit und Verträglichkeit von Tinlarebant zu bewerten sowie dessen Potenzial, die Wachstumsrate der atrophischen Läsionen bei GA-Patienten zu reduzieren. Die USA führten die Einschreibungen an, was ein starkes Interesse an der oralen Behandlungsoption im Vergleich zu den bestehenden invasiven Alternativen zeigt.
Dieser Meilenstein ist besonders bedeutsam, da derzeit keine zugelassenen oralen Behandlungen für GA existieren, eine fortgeschrittene Phase der trockenen AMD, die durch fortschreitenden Sehverlust aufgrund wachsender Läsionen in der Netzhaut gekennzeichnet ist. Das Unternehmen plant, Zwischenergebnisse zur Halbzeit der Studie zu veröffentlichen.
- Successful completion of enrollment for Phase 3 PHOENIX trial with 500 subjects globally
- Strong enrollment interest, particularly in the United States
- Tinlarebant offers potential as first oral treatment option for GA, compared to existing invasive alternatives
- Multi-country trial presence across 8 nations indicates broad development scope
- 24-month trial duration indicates results won't be available in immediate future
- No efficacy data available yet from the trial
- Company faces significant unmet medical need with no currently approved oral treatments for GA
Insights
Belite Bio's Phase 3 PHOENIX trial completion of enrollment marks crucial progress for the only oral therapy candidate for Geographic Atrophy.
Belite Bio has reached a significant clinical milestone with the completion of enrollment in their pivotal Phase 3 PHOENIX trial for Tinlarebant in Geographic Atrophy (GA). This achievement keeps the company on track in their clinical development timeline, with 500 subjects enrolled across eight countries, primarily led by U.S. recruitment.
What makes Tinlarebant particularly noteworthy is its oral administration - a potential key differentiator in a market currently limited to invasive treatment options. The company's leadership specifically highlighted this advantage, suggesting it contributed to strong enrollment interest, particularly in the United States.
The trial's 24-month duration means the study will continue through mid-2027, though the company plans to share interim results at the study's midpoint, likely in 2026. These interim results will provide the first indication of whether Tinlarebant can effectively slow atrophic lesion growth, the primary endpoint and key clinical marker of disease progression.
Geographic Atrophy represents an attractive market opportunity with significant unmet need. As the advanced stage of dry AMD, it's a leading cause of vision loss in older adults, with no currently approved oral treatments. Patients with GA develop retinal lesions that progressively impact central vision and daily activities like reading and driving.
This enrollment completion puts Belite Bio in position to potentially address this treatment gap with a convenient, once-daily oral tablet, should the trial demonstrate efficacy in slowing disease progression.
- 500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia
SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD).
“Completing enrollment in the PHOENIX trial marks an important milestone for Belite Bio as we advance our lead candidate, Tinlarebant, for the treatment of geographic atrophy,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “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. We remain committed to advancing Tinlarebant through late-stage development and look forward to sharing interim results at the midpoint of the PHOENIX trial.”
“We are pleased to announce the completion of enrollment in our pivotal clinical trial in geographic atrophy, a milestone that reflects strong global interest in our investigational therapy," says Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. "The United States led enrollment by a significant margin, underscoring the appeal of a convenient, once-daily oral tablet compared to existing invasive treatment options.”
“Geographic atrophy is a progressive and debilitating condition that can severely impact a person’s vision and therefore quality of life, yet treatment options remain limited,” said Dr. David Rhee, Principal Investigator at one of the top recruiting sites for the PHOENIX trial. “The PHOENIX study is designed to evaluate the efficacy of Tinlarebant in slowing the growth of atrophic lesions, a key clinical marker of disease progression. Completing enrollment is a meaningful step in advancing research for this patient population, and I look forward to seeing the results from this important study.”
Dry AMD is a leading cause of vision loss in older adults. GA is the advanced stage of dry AMD. People living with GA develop lesions within the retina that can impact their vision and diminish the ability to perform everyday activities like reading and driving. As the lesions expand, patients typically experience progressive loss of central vision. Currently, there are no approved, orally administered treatments for GA and no approved therapies for the earlier stages of dry AMD, such as intermediate AMD.
The PHOENIX study is a 24-month, randomized, double-masked, placebo-controlled, multicenter, pivotal Phase 3 trial. The study is ongoing across sites in the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia.
About Tinlarebant
Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) patients. Currently, there are no FDA approved treatments for STGD1 and no approved orally administered treatments for GA. Therefore, if approved, Tinlarebant would be a novel oral therapeutic addressing an unmet medical need in both STGD1 and GA. Tinlarebant has been granted Rare Pediatric Disease designation, Fast Track Designation, and Breakthrough Therapy Designation in the United States as well as Orphan Drug Designation in the United States, Europe, and Japan. It has also received Sakigake (Pioneer Drug) Designation in Japan for STGD1.
About Belite Bio
Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite’s lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook or visit us at www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking statements about future expectations and plans, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding Belite Bio’s advancement of, and anticipated future activities on preclinical studies, clinical development, regulatory milestones, and commercialization of its product candidates; and any other statements containing the words “expect”, “hope”, “indicate”, “look forward to”, and similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; the potential efficacy of Tinlarebant, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Media and Investor Relations Contact:
Jennifer Wu
ir@belitebio.com
Julie Fallon
belite@argotpartners.com
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