Topline 16-week data expected in the fourth quarter of 2024
SOUTH SAN FRANCISCO, CA, USA I December 12, 2023 I UNITY Biotechnology, Inc. (“UNITY”) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patients have been dosed in the Phase 2 ASPIRE study of UBX1325 (foselutoclax), a Bcl-xL inhibitor being evaluated head-to-head against standard of care anti-VEGF in patients with diabetic macular edema (DME).
“Many patients with DME have poor vision despite frequent anti-VEGF injections and there is an urgent need to develop new treatment options for such patients,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “There has been great interest from the physician community in the therapeutic potential of UBX1325, which is based on a novel senolytic mechanism of action, and we are excited to have dosed our first patients in the ASPIRE study. We look forward to sharing initial results from the study in the fourth quarter of 2024.”
ASPIRE is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active diabetic macular edema (DME) who are not achieving optimal benefit from standard of care. It is expected to enroll about 40 subjects who will be randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months. The primary efficacy endpoint will be mean change from baseline in Best Corrected Visual Acuity (BCVA) to week 24. Secondary endpoints will include change in BCVA over time, and central subfield thickness (CST) change from baseline to week 24. Initial 16-week data is expected in the fourth quarter of 2024 and 24-week data expected in the first quarter of 2025. More information about ASPIRE (NCT06011798) can be found here.
About UBX1325
UBX1325 is an investigational compound being studied in retinal diseases including DME and wet AMD 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 Best Corrected Visual Acuity (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. 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 Twitter and LinkedIn.
SOURCE: UNITY Bio
Post Views: 410
Topline 16-week data expected in the fourth quarter of 2024
SOUTH SAN FRANCISCO, CA, USA I December 12, 2023 I UNITY Biotechnology, Inc. (“UNITY”) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patients have been dosed in the Phase 2 ASPIRE study of UBX1325 (foselutoclax), a Bcl-xL inhibitor being evaluated head-to-head against standard of care anti-VEGF in patients with diabetic macular edema (DME).
“Many patients with DME have poor vision despite frequent anti-VEGF injections and there is an urgent need to develop new treatment options for such patients,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “There has been great interest from the physician community in the therapeutic potential of UBX1325, which is based on a novel senolytic mechanism of action, and we are excited to have dosed our first patients in the ASPIRE study. We look forward to sharing initial results from the study in the fourth quarter of 2024.”
ASPIRE is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept in previously treated patients with active diabetic macular edema (DME) who are not achieving optimal benefit from standard of care. It is expected to enroll about 40 subjects who will be randomized 1:1 to receive either 10 μg UBX1325, or 2 mg of aflibercept control injections every eight weeks for six months. The primary efficacy endpoint will be mean change from baseline in Best Corrected Visual Acuity (BCVA) to week 24. Secondary endpoints will include change in BCVA over time, and central subfield thickness (CST) change from baseline to week 24. Initial 16-week data is expected in the fourth quarter of 2024 and 24-week data expected in the first quarter of 2025. More information about ASPIRE (NCT06011798) can be found here.
About UBX1325
UBX1325 is an investigational compound being studied in retinal diseases including DME and wet AMD 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 Best Corrected Visual Acuity (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. 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 Twitter and LinkedIn.
SOURCE: UNITY Bio
Post Views: 410
