Pharma Holdings, led by Johnny I. Ryvoll in Norway, sought regulatory advice from EATRIS regarding the development of a nasal spray formulation for LTX-109, a synthetic antimicrobial agent designed to treat upper respiratory viral infections like SARS-CoV-2 and Influenza. This advice aimed to clarify whether additional pre-clinical studies were necessary to transition from a nasal gel formulation to a nasal spray.
LTX-109 is a novel peptidomimetic that acts by lysing the membranes of pathogens, including viruses. It has demonstrated broad-spectrum antimicrobial activity in pre-clinical and clinical studies, with no safety concerns identified. Pharma Holdings had previously conducted various studies on the gel formulation of LTX-109, and as of November 2023, 381 subjects had been treated with the gel. The transition to a nasal spray required regulatory clarification to determine if any additional studies were needed before proceeding to clinical trials.
Through ISIDORe’s support, EATRIS regulatory experts reviewed Pharma Holdings’ briefing documents and provided advice during an online session. This guidance proved valuable for Pharma Holdings’ interactions with suppliers and contract research organizations (CROs), and it shaped their formal scientific advice submission to the European Medicines Agency (EMA).
The advice helped streamline Pharma Holdings’ development process, guiding the pre-clinical assessments for the nasal spray and contributing to their application for in vivo studies, which later confirmed the efficacy of the LTX-109 nasal spray against SARS-CoV-2 in animal models.