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– Topline 12-week results for Phase 2 study of UBX0101 in osteoarthritis expected in 3Q 2020 –
– First-in-human study for UBX1325 in age-related eye disease expected to commence in 2H 2020 –
SOUTH SAN FRANCISCO, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today provided updates on its lead development programs.
“The second half of 2020 will be an eventful period for UNITY, particularly for our cellular senescence programs for osteoarthritis and for age-related eye diseases,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “We expect important results from both our Phase 2 and Phase 1b studies of UBX0101 in patients with painful osteoarthritis of the knee where we see significant unmet need and the opportunity to develop a new class of therapeutic options with durable benefit. We are also excited to advance UBX1325 into clinical development in age-related eye diseases, such as diabetic macular edema and diabetic retinopathy, where senescent cell burden has been implicated and where clinicians and patients have a strong need for novel therapeutic options. UBX1325 is a Bcl-XL inhibitor and represents the second mechanism we are advancing to the clinic.”
UBX0101 - Osteoarthritis
In February 2020, UNITY announced completion of enrollment of its Phase 2 study of UBX0101, a p53/MDM2 interaction inhibitor, in patients with moderate-to-severe osteoarthritis of the knee. The study is randomized, double-blind, and placebo-controlled and will evaluate three doses (0.5 mg, 2.0 mg and 4.0 mg) of UBX0101 administered via a single intra-articular injection. UNITY expects to announce 12-week results from the study in the third quarter of 2020.
UBX1325 - Ophthalmology
UNITY announced that it has completed Investigational New Drug (IND) -enabling studies with UBX1325, a senolytic, small molecule inhibitor of the anti-apoptotic Bcl-2 family member, Bcl-xL. UNITY expects to file an IND for a Phase 1 safety study for UBX1325 and, assuming clinical sites are able to recruit and retain investigators and study staff and screen and enroll patients during the ongoing COVID 19 pandemic, to initiate a Phase 1 study in the second half of 2020 and obtain initial results from the study in 2021. The overall clinical program is directed at multiple age-related diseases of the eye, such as diabetic macular edema, diabetic retinopathy and age-related macular degeneration.
In connection with the selection of UBX1325 as its lead molecule for the ophthalmology program, UNITY executed an amendment to an existing compound license agreement with Ascentage Pharma Group Corp Limited (“Ascentage Pharma”). The amended compound license agreement grants UNITY exclusive worldwide development and commercialization rights and non-exclusive manufacturing rights outside of Greater China (China, Hong Kong, Macau and Taiwan) for UBX1325 in all non-oncology indications. Inside Greater China, UNITY is obligated to commercialize UBX1325 through a joint venture with Ascentage Pharma.
UNITY is developing therapeutics to extend healthspan with an initial focus on cellular senescence. UNITY believes that the accumulation of senescent cells is a fundamental mechanism of aging and a driver of many common age-related diseases. Cellular senescence is a natural biological state in which a cell permanently halts division. As senescent cells accumulate with age, they begin secreting inflammatory factors, proteases, fibrotic factors, and growth factors, that disturb the tissue micro-environment. This collection of secreted proteins is referred to as the Senescence Associated Secretory Phenotype, or SASP. UNITY is developing senolytic medicines to eliminate senescent cells and thereby stop the production of the SASP, which UNITY believes addresses a root cause of age-related diseases. By stopping the production of the SASP at it source, UNITY believes senolytic medicines could slow, halt, or reverse diseases such as osteoarthritis and age-related eye diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.
This press release contains forward-looking statements including statements related to the potential for UNITY to develop therapeutics to extend healthspan, statements related to the timing of certain regulatory filings, the initiation of clinical trials and the release of data from clinical trials, and UNITY’s ability to successfully complete ongoing and planned clinical trials. 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 the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process and risks relating to UNITY’s understanding of senescence biology. We may not actually achieve the plans, intentions or expectations disclosed in our 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, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 2020, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
This press release concerns drug candidates that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. All forward-looking statements are qualified in their entirety by this cautionary statement.