Memo Therapeutics Advances Kidney Transplant Drug to Phase 3 Despite Primary Endpoint Miss

Memo Therapeutics, a Swiss biotech company, has announced plans to move forward with phase 3 trials for its kidney transplant drug candidate, potravitug, despite failing to meet the primary endpoint in a recent phase 2 study. The decision highlights the complex landscape of drug development in the transplant field and underscores the potential of novel therapies in addressing unmet medical needs.

Phase 2 Trial Results and Analysis

The phase 2 trial, which enrolled 95 kidney transplant recipients infected with BK polyomavirus, aimed to evaluate the efficacy of potravitug, an anti-BK polyomavirus antibody. While the study failed to demonstrate a statistically significant difference in the proportion of patients with undetectable virus levels in the blood at Week 20 compared to placebo, Memo Therapeutics emphasized other promising aspects of the data.

Notably, the treatment group showed significantly higher viral response with resolution of biopsy-proven BK polyomavirus nephropathy (BKPyVAN). The company reported a decrease in histological evidence of BKPyVAN from 51.2% at baseline to 31.6% at Week 20 in the treatment group, while no change was observed in the placebo group. This improvement in underlying disease progression has bolstered the company's confidence in the drug's potential.

Safety data from the trial was also encouraging, with no treatment-related serious adverse events or withdrawals due to adverse events reported. These findings support the continued development of potravitug as a potentially safe treatment option for kidney transplant patients affected by BK polyomavirus.

Future Development and Regulatory Strategy

Despite the primary endpoint miss, Memo Therapeutics is pressing ahead with plans for a phase 3 program. The company intends to engage with regulators later this year to discuss the design of the pivotal trial. Potravitug's development is further supported by its fast-track designation from the U.S. Food and Drug Administration (FDA), which may expedite the review process.

The decision to advance to phase 3 is significant, given the current lack of FDA-approved drugs targeting BK polyomavirus in transplant patients. This move positions Memo Therapeutics at the forefront of addressing an important unmet medical need in transplant medicine.

Competitive Landscape and Industry Context

Memo Therapeutics' progress with potravitug comes amid a challenging environment for developing therapies against BK polyomavirus. Other companies in the field have faced setbacks:

• Vera Therapeutics' candidate MAU868 has seen limited progress since completing phase 2 trials in 2022, with the company shifting focus to another asset.
• AlloVir's posoleucel encountered phase 3 failures, leading the company to pursue a reverse merger in 2023.

These developments underscore the difficulties in bringing new treatments to market in this indication and highlight the potential impact of Memo Therapeutics' continued pursuit of potravitug's development.

As the pharmaceutical industry continues to seek effective treatments for transplant-related complications, the outcome of potravitug's phase 3 program will be closely watched by researchers, clinicians, and patients alike. The upcoming presentation of additional phase 2 data at the World Transplant Congress is expected to provide further insights into the drug's potential and may shape the design of future clinical trials in this challenging therapeutic area.