An independent data safety monitoring board (DSMB) has conducted the first of two planned Sample Size Reestimations (SSR1) of Phase 3 URIROX-2 Trial of Allena Pharmaceuticals Inc's (NASDAQ:ALNA) reloxaliase for enteric hyperoxaluria.
- Hyperoxaluria increases the risk of kidney stones and, in more severe cases, Chronic Kidney Disease and even kidney failure.
- Based on its unblinded analysis, the DSMB has recommended increasing the trial size from an initial 200 to 400.
- Based on this recommendation, the company believes that the separation between the reloxaliase and placebo groups for the UOx primary endpoint is lower than expected.
- Allena has decided to terminate the URIROX-2 study and plans to initiate the process of closing the study promptly. No further clinical studies of reloxaliase are planned at this time.
- Related: Allena Stock Is Surging In Premarket Today As It Explores Strategic, Financing Alternatives.
- The company will continue its second clinical program, ALLN-346, in Phase 2a development with FDA Fast-Track designation for hyperuricemia in gout and chronic kidney disease patients.
- Allena said it is currently enrolling patients in two Phase 2a studies for the program.
- However, the company noted it has limited financial resources, and there can be no assurance that these trials will be completed or that they will be successful if completed.
- Price Action: ALNA shares are down 45.2% at $0.27 on the last check Monday.
