Guard Therapeutics International AB (publ) announced further information regarding the development strategy for the investigational drug RMC-035. An advisory meeting with the U.S. Food and Drug Administration (FDA) will be requested to explore dose optimization and the framework for a future registrational trial for the prevention of kidney injury in open-heart surgery. The development strategy is based on the recent top-line results of the Phase 2 AKITA study, which demonstrated statistically significant and clinically relevant long-term kidney-protective effects of RMC-035 after open-heart surgery.

As a first step, the company plans to engage with the FDA concerning AKITA study results and subsequent development steps. To facilitate this, Guard Therapeutics is seeking an advisory meeting which is anticipated to take place around the turn of the year 2023/24 based on standard timelines. The company intends to proceed as planned to determine the optimal dose of RMC-035.

Based on the clear kidney-protective effects of RMC-035 in the AKITA study, alternative development paths will also be evaluated with the aim of reducing the time and cost to market approval. This includes the possibility of obtaining a so-called Breakthrough Therapy designation - an FDA program aimed at expediting the development and review of drugs targeting serious or life-threatening conditions. More details regarding the clinical plan are expected to be communicated after the planned advisory meeting with the FDA.

After determining the optimal dose in open-heart surgery, the company also intends to advance RMC-035 in the kidney transplantation indication into the next clinical development phase. With demonstrated proof-of-concept and an established dose in open-heart surgery., there are potential opportunities to proceed directly to a pivotal phase 2b/3 study in kidney transplantation.