UNITY Biotechnology Announces Publication in NEJM Evidence Highlighting the Potential of Senolytic Therapeutics to Provide Long-Term Improvements in Vision in DME
UNITY Biotechnology [NASDAQ: UBX] announced the publication of Phase 2 BEHOLD study results for UBX1325 in diabetic macular edema (DME) patients in NEJM Evidence. The study demonstrated that selective clearance of senescent cells in the retina led to long-lasting vision improvements, with patients experiencing meaningful and sustained visual acuity enhancement for 1 year after a single injection.
The company is currently conducting a Phase 2b ASPIRE study comparing multiple doses of UBX1325 head-to-head with aflibercept. Topline 24-week and 36-week data was released on March 24, 2025, with complete 36-week data expected in Q2 2025.
UNITY Biotechnology [NASDAQ: UBX] ha annunciato la pubblicazione dei risultati dello studio di Fase 2 BEHOLD su UBX1325 in pazienti con edema maculare diabetico (DME) su NEJM Evidence. Lo studio ha dimostrato che la rimozione selettiva delle cellule senescenti nella retina ha portato a miglioramenti duraturi della vista, con pazienti che hanno sperimentato un aumento significativo e stabile dell'acuità visiva per 1 anno dopo una singola iniezione.
Attualmente l'azienda sta conducendo uno studio di Fase 2b ASPIRE che confronta diverse dosi di UBX1325 direttamente con aflibercept. I dati principali a 24 e 36 settimane sono stati resi noti il 24 marzo 2025, mentre i dati completi a 36 settimane sono attesi nel secondo trimestre del 2025.
UNITY Biotechnology [NASDAQ: UBX] anunció la publicación de los resultados del estudio BEHOLD de Fase 2 para UBX1325 en pacientes con edema macular diabético (DME) en NEJM Evidence. El estudio demostró que la eliminación selectiva de células senescentes en la retina condujo a mejoras visuales duraderas, con pacientes que experimentaron un aumento significativo y sostenido en la agudeza visual durante 1 año tras una sola inyección.
La empresa está llevando a cabo actualmente un estudio ASPIRE de Fase 2b que compara múltiples dosis de UBX1325 frente a aflibercept. Los datos principales a 24 y 36 semanas se publicaron el 24 de marzo de 2025, y se esperan los datos completos a 36 semanas en el segundo trimestre de 2025.
UNITY Biotechnology [NASDAQ: UBX]는 NEJM Evidence에 당뇨병성 황반부종(DME) 환자를 대상으로 한 UBX1325의 2상 BEHOLD 연구 결과를 발표했습니다. 연구 결과, 망막 내 노화 세포의 선택적 제거가 장기적인 시력 개선으로 이어졌으며, 환자들은 단 한 번의 주사 후 1년 동안 의미 있고 지속적인 시력 향상을 경험했습니다.
현재 회사는 UBX1325의 여러 용량을 아플리버셉트와 직접 비교하는 2b상 ASPIRE 연구를 진행 중입니다. 24주 및 36주 주요 데이터는 2025년 3월 24일에 공개되었으며, 36주 완전 데이터는 2025년 2분기에 발표될 예정입니다.
UNITY Biotechnology [NASDAQ : UBX] a annoncé la publication des résultats de l'étude de phase 2 BEHOLD portant sur UBX1325 chez des patients atteints d'œdème maculaire diabétique (DME) dans NEJM Evidence. L'étude a démontré que le nettoyage sélectif des cellules sénescentes dans la rétine entraînait des améliorations visuelles durables, les patients ayant bénéficié d'une amélioration significative et soutenue de l'acuité visuelle pendant 1 an après une seule injection.
L'entreprise mène actuellement une étude de phase 2b ASPIRE comparant plusieurs doses d'UBX1325 en tête-à-tête avec l'aflibercept. Les données principales à 24 et 36 semaines ont été publiées le 24 mars 2025, et les données complètes à 36 semaines sont attendues au deuxième trimestre 2025.
UNITY Biotechnology [NASDAQ: UBX] gab die Veröffentlichung der Ergebnisse der Phase-2-BEHOLD-Studie zu UBX1325 bei Patienten mit diabetischem Makulaödem (DME) in NEJM Evidence bekannt. Die Studie zeigte, dass die selektive Beseitigung seneszenter Zellen in der Netzhaut zu langanhaltenden Verbesserungen des Sehvermögens führte, wobei die Patienten nach einer einzigen Injektion eine bedeutende und anhaltende Steigerung der Sehschärfe über 1 Jahr erfuhren.
Das Unternehmen führt derzeit eine Phase-2b-ASPIRE-Studie durch, die mehrere Dosen von UBX1325 direkt mit Aflibercept vergleicht. Die wichtigsten Daten für 24 und 36 Wochen wurden am 24. März 2025 veröffentlicht, vollständige 36-Wochen-Daten werden im 2. Quartal 2025 erwartet.
- Successful Phase 2 BEHOLD study results published in prestigious NEJM Evidence journal
- Single injection showed statistically significant vision improvements lasting up to 48 weeks
- Demonstrated disease-modifying potential through novel mechanism of action
- Advanced to Phase 2b ASPIRE study with head-to-head comparison against established treatment
- Full efficacy comparison against existing treatments not yet established
- Additional studies needed to confirm long-term safety and efficacy
Insights
UNITY's Phase 2 results published in NEJM Evidence show promising once-yearly DME treatment through novel senolytic mechanism.
The publication of UNITY Biotechnology's Phase 2 BEHOLD study in the prestigious NEJM Evidence journal represents significant validation for their senolytic approach to treating diabetic macular edema (DME). The data demonstrates that UBX1325 provided statistically significant and clinically meaningful vision improvements lasting a full 48 weeks after just a single injection in patients with advanced DME. This durability profile stands in stark contrast to current standard-of-care treatments that typically require frequent intravitreal injections, creating substantial treatment burden.
What makes UBX1325 particularly notable is its novel mechanism targeting senescent cells in the retina. Rather than just addressing symptoms, this approach aims to remodel retinal vasculature by removing cells that contribute to inflammation and disease progression. This represents a potential paradigm shift in treatment approach.
The ongoing Phase 2b ASPIRE study directly comparing multiple doses of UBX1325 against aflibercept (a current standard therapy) will provide critical comparative efficacy data. Some topline results were disclosed on March 24, 2025, with full 36-week data expected next quarter. The peer-reviewed publication solidifies the scientific credibility of UNITY's senolytic platform in ophthalmology applications and provides foundation for their development strategy in diseases of aging.
UNITY's once-yearly DME treatment shows sustained vision improvement, potentially reducing treatment burden compared to current monthly injections.
The publication of UNITY's Phase 2 BEHOLD study in NEJM Evidence represents a potentially significant advancement in DME treatment. Current standard anti-VEGF therapies like aflibercept require frequent injections - typically every 4-8 weeks - creating substantial burden for both patients and healthcare systems. The data showing meaningful vision improvements persisting for 48 weeks after a single UBX1325 injection addresses this key limitation.
From a clinical perspective, DME remains a leading cause of vision loss among working-age adults with diabetes. What distinguishes UBX1325 is its mechanism targeting senescent cells rather than just VEGF. By removing these dysfunctional cells that secrete inflammatory factors and contribute to vascular leakage, UBX1325 aims to restore normal retinal function.
The therapeutic approach is particularly interesting because it targets an underlying disease mechanism rather than merely suppressing symptoms. If the ongoing Phase 2b ASPIRE study comparing UBX1325 directly against aflibercept confirms these benefits, it could potentially offer DME patients an important treatment alternative with substantially reduced treatment frequency - perhaps annual versus monthly injections. For patients managing the chronic burden of diabetes, reducing the frequency of eye injections would represent a meaningful quality-of-life improvement.
SOUTH SAN FRANCISCO, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that the peer-reviewed journal NEJM Evidence published results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). As reported in the article titled, “Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema,” the results suggested that the selective clearance of senescent cells in the retina provided disease-modifying and long-lasting improvements in vision in patients with DME, supporting the potential of UBX1325 as a novel modality for retinal diseases.
“By targeting senescent cells, we expect to remodel the retinal vasculature, which should lead to improvements in retinal function,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY and an author of the paper. “We see the impact of this approach in action in the BEHOLD study, in which patients experienced meaningful and sustained improvements in their visual acuity for 1 year after a single injection of UBX1325. By selectively targeting an underlying cause of inflammation and disease progression, senolytic therapies could provide a valuable future treatment option for DME patients.”
As previously disclosed and presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, a single injection of the senolytic candidate UBX1325 led to a statistically significant and clinically meaningful improvement in vision with extended durability through 48 weeks in patients with advanced DME. UNITY is currently conducting a Phase 2b ASPIRE study to evaluate multiple doses of UBX1325 in a head-to-head comparison to aflibercept. Topline 24-week and 36-week data was disclosed on March 24, 2025 and full 36-week data is expected in the second quarter of 2025.
About the BEHOLD Study
The proof-of-concept Phase 2 BEHOLD study is a multi-center, randomized, double-masked, sham-controlled study designed to evaluate the safety, tolerability, efficacy and durability of a single 10 mcg dose of UBX1325 in patients with DME. The study enrolled 65 patients who, despite being on anti-VEGF treatment for at least 6 months, displayed persistent visual acuity deficits (73 ETDRS letters, approximately 20/40, or worse) and residual retinal fluid (CST ≥300 microns). At baseline, patients in the study had an average visual acuity of 61.4 ETDRS letters and a CST of approximately 439.6 microns. In the 6 months prior to study enrollment, patients received an average of 4 anti-VEGF injections, with the last anti-VEGF injection occurring 3-6 weeks prior to randomization. Fifty patients completed the 48-week study extension. More information about the study is available here (NEJM Evidence) and here.
About UBX1325
UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of BCL-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting BCL-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. Multiple doses of UBX1325 are currently being evaluated in the ASPIRE Phase 2b study for people with DME who are not achieving optimal benefit from anti-VEGF drugs (NCT06011798). UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease.
About UNITY
UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on X and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, UNITY’s expectations regarding potential benefits, activity, effectiveness, safety, and market opportunity of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME and other ophthalmologic diseases, the expected timing of results of the clinical trial in UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including risks related to delay or disruption in clinical trials, risks relating to the uncertainties inherent in the drug development process, risks relating to UNITY’s understanding of senescence biology, and risks related to UNITY’s ability to raise funding. This press release also contains data from third parties relating to market size and treatment outcomes, which involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. The Company may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general and the sufficiency of its cash runway, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission on April 22, 2025, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
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FAQ
What were the key findings of UBX1325 Phase 2 BEHOLD study in DME patients?
How does UBX1325 work in treating diabetic macular edema?
When will UNITY Biotechnology release full 36-week data for the ASPIRE study?
What is the current development stage of UBX1325 for DME treatment?
