Memo Therapeutics AG Publishes Phase I Safety, Tolerability, and Pharmacokinetics Study for Neutralizing Antibody Targeting BKPyV Infection in Clinical and Translational Science

• First-in-human, Phase I, randomized, placebo-controlled study, successfully demonstrated safety and tolerability of potravitug in healthy volunteers
• The Company recently announced the results from its Phase II placebo-controlled clinical trial of potravitug which showed biopsy-proven resolution of BK polyomavirus nephropathy in kidney transplant recipients
• Plans are underway to progress potravitug into Phase III development with the potential to transform the treatment landscape for kidney transplant patients with BK polyomavirus infection
  
  

Schlieren / Zurich, Switzerland, 19 August, 2025 – Memo Therapeutics AG (“MTx”), a late-stage biotech company translating unique immune responses into superior medicines to treat viral infections and cancer, has published Phase I clinical data in Clinical and Translational Science, highlighting the safety, tolerability, and pharmacokinetics (PK) of its lead clinical asset, potravitug, a highly potent human monoclonal antibody targeting BK polyomavirus (“BKPyV”).

The first-in-human, Phase I, randomized, placebo-controlled study (NCT05358106), successfully demonstrated the safety and tolerability of potravitug in healthy adults. The treatment was well tolerated, with no serious adverse events reported which established a robust safety foundation for the recently completed Phase II clinical trial.

The study established a treatment dose of 1000 mg for potravitug administered four times with a four-week interval between doses, to maintain therapeutic concentrations for at least one year. This was supported by PK/PD modelling and a PK profile consistent with other therapeutic monoclonal antibodies in clinical use.

The full publication can be accessed here: First‐In‐Human, Randomized, Placebo‐Controlled, SAD and MAD Trial to Evaluate Safety, Tolerability, and PK/PD Modeling of Potravitug in Healthy Adults - May - 2025 - Clinical and Translational Science - Wiley Online Library

Erik van den Berg, CEO of MTx, said "The positive safety profile and convenient dosing regimen for potravitug demonstrated in this Phase I study establishes a strong basis for the development of potravitug as a first-in-class therapeutic candidate for treating BK polyomavirus infection in kidney transplantation. Following the recent publication of our exciting Phase II results, we are now planning to progress potravitug into a Phase III trial."

The company recently published studies in Frontiers in Pharmacology, demonstrating the ability of therapeutic IgG1 antibodies to effectively cross the kidney filtration barrier, and in PLOS Pathogens, highlighting the discovery and characterization of picomolar potent lead asset, potravitug.

Potravitug was awarded U.S. FDA Fast Track designation in May 2023. MTx recently announced promising results from its Phase II placebo-controlled clinical trial of potravitug which were presented at the World Transplant Congress earlier this month.

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About Memo Therapeutics AG
Memo Therapeutics AG (“MTx”) is a late-stage biotech company translating unique human immune responses into superior medicines through the development of best-in-class antibodies to treat viral infections and cancer. The Company’s lead program, potravitug, targeting BKPyV infection in kidney transplant recipients is planned to start Phase III clinical development in 2026. BKPyV infections decrease kidney functionality and longevity and reduce patient survival. Potravitug has the potential to become a first-in-class BKPyV disease-modifying therapy for kidney transplant patients with a market potential of up to $2bn p.a..

Alongside potravitug, MTx is focused on discovering novel antibody-target-pairs in oncology. Underpinning MTx’s core assets is its proprietary DROPZYLLA^® technology, an antibody repertoire copying engine with high-throughput screening capabilities. MTx is a private company located in Schlieren / Zurich and backed by investors including Ysios Capital, Kurma Partners, Pureos Bioventures, Swisscanto, Vesalius Biocapital and Adjuvant Capital. Learn more at  www.memo-therapeutics.com, and on LinkedIn.

About BK polyomavirus in kidney transplant recipients
More than 100,000 kidney transplants are conducted worldwide every year. BKPyV can become reactivated in up to 50% of these patients and up to 70% of patients with BKPyV viremia develop BKPyV nephropathy, which significantly increases the risks of kidney loss and patient death.

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