Unity's efforts do not age well

Research into biological pathways associated with ageing has attracted much attention, and funding, but much work remains early and in the hands of private companies. With a focus on "senolytics" and a Nasdaq listing, Unity Biotech represented a rare opportunity for investors to dabble in this nascent field, though the failure of the company's only clinical-stage candidate shows that this remains high-risk. UBX0101 was being tested in moderate to severe painful osteoarthritis of the knee; a phase II study found no statistically significant difference between any treatment arm and placebo. The primary endpoint was Womac-A, a questionnaire to assess pain, and the company blamed an unusually large placebo effect for the outcome. Unity's focus is senescent cells, which have stopped dividing and have been linked to a number of age-related diseases. UBX0101 was said to inhibit MDM2/p53 protein interaction, which the company claimed could eliminate senescent cells. A second project, UBX1325, is expected to enter the clinic in ophthalmology later this year. This has a different mechanism, targeting an apoptosis regulatory protein, Bcl-xL, but the 62% plunge in Unity stock this morning suggests that little confidence remains in the company's approach.

Unity's phase II failure (NCT04129944)
UBX0101 arm Placebo-adjusted change P value
0.5mg (n = 45) 0.093 0.5222
2.0mg (n = 46) -0.035 0.8069
4.0mg (n = 46) -0.002 0.987
Primary endpoint: change from baseline in Womac-A (0-4 scale) at week 12. Source: press release.


Selected anti-ageing companies
Company Most advanced product MoA Note
Unity Biotechnology UBX0101 p53/MDM2 inhibition Ph2 clinical failure in osteoarthritis
Samumed Lorecivivint   Wnt/beta-catenin signalling pathway modulator Private, ph3 osteoarthritis study, primary completion 2021
Celularity PDA-001 Natural killer cell therapy Private (Celgene spinout), Crohn's disease said to be ph3-ready
Restorbio RBT101 + sirolimus mTORC1 inhibitors Respiratory illness study failed in 2019, Ph1b/2a Parkinson's disease study ongoing
Calico Research project Undisclosed Private, backed by Google
Source: company websites.

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