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UNITY Biotechnology Reports Promising Topline Data from Phase 1 First-in-human Study of UBX0101 in Patients ...

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#1 Engadin

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Posted 18 June 2019 - 12:24 PM


UNITY Biotechnology Reports Promising Topline Data from Phase 1 First-in-human Study of UBX0101 in Patients with Osteoarthritis of the Knee

 

SAN FRANCISCO, June 18, 2019 (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 announced promising results from its first-in-human Phase 1 study of UBX0101 in patients with moderate to severe osteoarthritis (OA) of the knee. The study demonstrated that UBX0101 was safe and well-tolerated. Improvement in several clinical measures, including pain, function, as well as modulation of certain senescence-associated secretory phenotype (SASP) factors and disease-related biomarkers was observed after a single dose of UBX0101.

 

"This Phase 1 study of UBX0101 is an important first step in exploring the potential of a senolytic approach in the treatment of a range of age-related diseases," said Keith Leonard, chairman and chief executive officer of UNITY. “We believe our novel approach to eliminating senescent cells has the potential to meaningfully impact healthspan.”

 

“New treatments for OA are desperately needed, especially an intervention that targets the biology of the condition that includes cell senescence,” said Richard F. Loeser, Jr., M.D., Director, UNC Thurston Arthritis Research Center Herman and Louise Smith Distinguished Professor of Medicine, Division of Rheumatology, Allergy & Immunology. “These exciting data are supportive of this very promising new approach for this chronic painful condition.”

 

 

Phase 1 Trial Design and Results

 

Trial Design

 

The Phase 1 clinical trial of UBX0101 is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and pharmacokinetics of a single intra-articular injection of UBX0101 in patients diagnosed with moderate to severe painful OA of the knee. UBX0101 is a p53/MDM2 interaction inhibitor that targets selective elimination of senescent cells.

 

In Part A, 48 patients were randomly assigned to receive one of six dose levels of UBX0101 (between 0.1 mg to 4 mg) or placebo in a 3:1 randomization. Primary endpoints were safety and tolerability. Secondary and exploratory endpoints included plasma pharmacokinetics, synovitis as measured by MRI, pain, and measurement of SASP factors and disease-related biomarkers present in synovial fluid and plasma.

 

In Part B, 30 patients were randomized to receive UBX0101 (4 mg dose) or placebo in a 2:1 randomization. Primary endpoints were safety and tolerability. Secondary and exploratory endpoints included changes in the levels of SASP factors and disease-related biomarkers present in synovial fluid and plasma, and pain. Synovial fluid samples were obtained at baseline and four weeks post-treatment.

 

 

Safety, Tolerability and PK

 

In Part A, UBX0101 was well tolerated up to the maximum administered dose of 4 mg. There were no serious adverse events and no patients discontinued because of an adverse event. There were no dose-dependent adverse events or relevant clinical laboratory findings. The majority (66%) of adverse events were mild.
             
In Part B, UBX0101 was well tolerated at the 4 mg dose. There were no serious adverse events and no patients discontinued because of an adverse event. The majority (75%) of adverse events were mild and there were no relevant clinical laboratory findings.
             
UBX0101 demonstrated dose-proportional plasma pharmacokinetics. Model-based predicitons of concentrations within the knee suggested that doses at or above 1 mg may be pharmacologically active. This informed the prospectively defined low dose (0.1, 0.2, and 0.4 mg) and high dose (1, 2, and 4 mg) groupings for analyses.

 

 

 

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#2 Engadin

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Posted 19 June 2019 - 06:50 PM

S O U R C E :   Yahoo! Finance

 

 

Here's Why Unity Biotechnology Dropped as Much as 20.4% Today

 

What happened

 

Shares of Unity Biotechnology (NASDAQ: UBX) fell over 20% today, before sharply recovering. This came after the company reported data from a phase 1 clinical trial for its lead drug candidate, UBX0101, in moderate to severe osteoarthritis. The two-part study demonstrated mixed results.

 

In part A of the study, patients taking various doses of the drug candidate demonstrated significant improvements in pain reduction compared to placebo at the 12-week mark. In part B of the study, all patients were given the highest dose of UBX0101, but didn't report statistically significant reductions in pain compared to placebo at the four-week mark.

 

As of 2:09 p.m. EDT, the stock had settled to a 8.9% loss.

 
 
So what

 

Today's news suggests that the search for medicines to increase longevity and stave off age-related diseases is far from over. Researchers simply don't have a great understanding of the complex molecular interactions that take place within the body and contribute to age-related diseases. Developing a drug compound that interacts with just one part of those complex systems and chemical cascades -- the infamous "Can a biologist fix a radio?" dilemma -- is unlikely to yield much success.

 

That doesn't mean it's not worth trying. Unity Biotechnology's approach is to develop therapeutics for cleaning up old, inefficient, and senescent cells (cells that don't divide) that contribute to disease progression.

 

UBX0101 specifically aims to inhibit the interaction of two proteins in order to trigger the elimination of senescent cells. The results were mixed from the phase 1 trial in moderate to severe osteoarthritis, insofar as pain management is concerned. But the company noted that changes in various biomarkers indicated a reduction in the number of senescent cells in patients receiving the experimental therapy.

 

 

Now what

 

Open-minded investors realize that Unity Biotechnology is likely to encounter a healthy amount of failure in the clinic. The question is whether the data generated from those failures deepens the understanding of age-related diseases such that longevity-based medicines can be successfully developed.

 

Given the complexity involved in this approach, investors shouldn't allocate an irresponsible amount of their portfolios to the company -- if it has a place in their portfolios at all.

 

 

 

 



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