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UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today announced further stretching of the Phase 1 bone up on of UBX in patients and moderate to severe osteoarthritis OA of the knee with a cohort of an additional 24 patients at the highest evaluated dose 4mg Part B. Towards measure SASP factors, an equal volume of synovial fluid is required in the knee dump capsule to collect a swatch.
In Part A of the Phase 1 study, UNITY sought to collect synovial fluid passing through simple aspiration; however, a amount of patients had an deficient amount of fluid for sample. Part B will provide an increased sample size for SASP assessment by allowing saline lavage in patients who do not have adequate fluid to stockpile via simple aspiration.
The lavage procedure was not conducted into Part A to avoid implied confounding effects the procedure may possibly have had on the measurement of safety and tolerability of UBX This lavage procedure was used successfully as a any of the previously conducted biomarker study to explore the rapport between senescence burden, SASP factors in synovial fluid, synovial soreness and OA disease severity.
It is that experience in patients that gives us the faith to initiate Part B next to the highest evaluated dose. The addition of Part B pursues review of aggregate blinded sanctuary, tolerability and drug exposure information from Part A, which has completed enrollment and a least of 2-week assessments of every one of patients.
These data support getting higher into a Part B detachment at the highest evaluated dose up 4 mg. Top-line results as of both Part A and Share out B are expected in the second quarter of Near the UBX Phase 1 Dispassionate Study The Phase 1 proven trial of UBX is a randomized, double-blind, placebo-controlled, single rising dose study evaluating the protection, tolerability and pharmacokinetics of a single intra-articular injection of UBX in patients diagnosed with decrease to severe OA of the knee.
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