Unity Biotechnology Setback, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

Unity Biotechnology suffers setback for lead drug candidate UBX0101

Unity Biotechnology Inc. (UBX) reported its 12-week data from Phase 2 clinical study in patients with painful osteoarthritis of the knee. The data did not show any statistically significant difference between any arm of UBX0101 and placebo at the 12-week endpoint for change from baseline. The change was measured using WOMAC-A which is a standard measurement of pain in osteoarthritis. The company has decided not to progress the drug candidate into pivotal studies. UNITY has also decided to focus on its ophthalmologic and neurologic disease programs in the near future.

The Phase 2 placebo-controlled, double-blind study enrolled 183 eligible patients. These patients were randomized and were administered placebo, 0.5 mg, 2.0 mg, or 4.0 mg of UBX0101 via a single intra-articular injection. The drug candidate was found to be well-tolerated at all dose levels. The adverse events were also in line with previously reported data. The data did not show any treatment-related serious Adverse Event. Only one patient had to discontinue on account of an unrelated cardiovascular event.

Unity plans to continue collecting data from the Phase 2 up to 24 week. It will also collect data from the ongoing Phase 1b high-dose, repeat-dose study. The data collection will likely be completed in the second half of 2020. Jamie Dananberg, M.D., chief medical officer of Unity:

While we are disappointed in the outcome of the 12-week results of the Phase 2 study of UBX0101, I would like to acknowledge our team's hard work and commitment to executing a robust study that has provided clear results."

However, the company stated that it remains positive about the potential of senescent cells towards managing ageing related ailments. Unity plans to advance its other product UBX1325 for retinal diseases. This drug candidate works by controlling Bcl-xL, a distinct senolytic target. The company also specified that its current cash, cash equivalents, and investments are sufficient to fund operations well into 2022.

Unity is testing UBC1967 for treating age-related ailments including age-related macular degeneration, diabetic macular edema, and proliferative diabetic retinopathy. It is a distinct senolytic small molecule inhibitors of specific members of the Bcl-2 family of apoptosis regulatory proteins. UBC1967 works on the same line as UBX1325. Both these compounds focus on proteins that are necessary for the survival of senescent cells.

The company is currently going through a transitional phase as it had a new CEO earlier this year. Anirvan Ghosh, the new person at the helm, earlier acted as Biogen's head of early R&D. He said:

While these are not the results we had hoped for, the evidence that senescent cells contribute to diseases of aging remains compelling, and we are excited to advance UBX1325 for retinal diseases, which inhibits Bcl-xL, a distinct senolytic target."

Unity mainly works on developing a new category of therapeutics to slow or reverse the ageing process. The company aims to do it by selectively eliminating or modulating senescent cells. Some of the main age-related diseases focused upon by the company are neurological diseases, pulmonary diseases, eye diseases, and osteoarthritis.

ChromaDex Corp. (CDXC) reported the results of a human trial of its Niagen in managing cardiovascular health. The study showed that Niagen (nicotinamide riboside) supplement was able to control signs of inflammation including inflammatory cytokines in vivo. The study was conducted in a small group of end-stage heart failure patients and was funded by NIH.

Another arm of the study was conducted ex vivo and showed elevated mitochondrial respiration. The data showed that the drug candidate was able to lower inflammatory factor expressions in peripheral blood mononuclear cells isolated from human subjects and treated with nicotinamide riboside.

The study carried out by the ChromaDex External Research Program, the patients with the most significant forms of heart failure (Stage D) were supplemented with NR. Their blood was analyzed to detect levels of pro-inflammatory signaling molecules. The analysis was done for the respiration rate of PBMCs in both in vivo and ex vivo models. PBMCs have been shown to play a major role in the inflammatory response leading to the decompensation and worsening of heart failure.

The pilot study showed that the daily NR supplementation for 5 to 9 days improved the respiratory rate of PBMCs while also optimizing the levels of pro-inflammatory cytokine gene expressions. Dr. Andrew Shao, ChromaDex Senior Vice President of Global Scientific & Regulatory Affairs said:

We look forward to seeing the results from additional ongoing clinical research to further our understanding of Niagen's impact on cardiovascular health."

ChromaDex is the exclusive licensee of Dr. Charles Brenner's patented NR. The company has already been granted more than 20 patents related to NR. It has published eleven human trials showing the safety and efficacy of ChromaDex. It has also gained government regulatory acceptance in the United States, the European Union, Australia, and Canada.

Vanda Pharmaceuticals Inc. (VNDA) reported that the interim analysis of its lead drug candidate tradipitant showed that it may quicken clinical improvement in SARS-CoV-2 (COVID-19) pneumonia. The finding was derived from a preliminary analysis of the first 60 patients enrolled in the ODYSSEY study.

ODYSSEY is an ongoing Phase III double-blind placebo-controlled trial. It aims to evaluate the efficacy and safety of tradipitant in treating neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection. The study was commenced in April 2020. Mihael H. Polymeropoulos, M.D., President and CEO of Vanda said:

These results, albeit preliminary, are exciting, offering the promise of a significant contribution in the treatment of COVID-19 and the prospect of making tradipitant part of the standard of care in accelerating recovery for patients with COVID-19 pneumonia."

The data demonstrated that a 14-day tradipitant treatment accelerated clinical improvement by day 7 while the drug candidate also numerically improved median time to clinical improvement by day 28. Both the treatment arms showed similar overall rates of improvement and mortality.

The study is expected to involve 300 patients. This is the first study evaluating tradipitant for this condition. The interim analysis was carried out for the better assessment of efficacy and safety of tradipitant. The study used a 7-point scale for evaluating clinical status. The clinical improvement was defined as an improvement of minimum 2 points in the 7-point ordinal scale.

Tradipitant is an NK-1R antagonist and is currently undergoing clinical development for various conditions including atopic dermatitis, motion sickness, and gastroparesis. However, the FDA has put a partial clinical hold on clinical protocols of longer than 12 weeks duration. The company had licensed the drug candidate from Eli Lilly and Company (LLY).

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Unity Biotechnology Setback, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha