A phase 2 trial of Memo Therapeutics’ kidney transplant drug candidate has missed its primary endpoint, adding to the list of setbacks in the indication. But the Swiss biotech saw promise in other aspects of the data set and outlined plans to move into phase 3.
The phase 2 trial tested Memo’s anti-BK polyomavirus antibody potravitug. Investigators randomized 95 kidney transplant recipients infected with the virus to receive potravitug or placebo. At Week 20, the proportion of patients with undetectable levels of the virus in the blood was statistically no higher in the treatment arm than in the control group, causing the trial to miss its primary endpoint.
However, Memo pointed to success against other measures to make the case for further development of the antibody. The treatment group had significantly higher viral response with resolution of biopsy-proven BK polyomavirus nephropathy (BKPyVAN).
“This histological improvement in BKPyVAN indicated resolution of the underlying disease, decreasing from 51.2% at baseline to 31.6% at Week 20 in the treatment group, while no change was observed in the placebo group,” Memo said in a statement.
Memo reported no treatment-related serious adverse events or withdrawals due to adverse events. The biotech will share more phase 2 data at the World Transplant Congress next month. In parallel, Memo is preparing to talk to regulators later this year about the design of a planned phase 3 program. Potravitug has a fast-track designation from the FDA.
No drugs against the virus are approved by the FDA. Vera Therapeutics has a rival candidate, MAU868, but progress stalled after it completed phase 2 back in 2022. The company is focused on bringing another asset, atacicept, to market. AlloVir was developing posoleucel for use against BK virus, wrapping up a phase 2 trial in 2022, but phase 3 failures led the company to enter into a reverse merger last year.