Enzymatica (ENZY) Study Result summary

Study design and methodology

• Combined in vivo (randomized, double-blind, placebo-controlled trial in 160+ endurance athletes) and in vitro (human airway epithelial cell) approaches to assess ColdZyme's effects on upper respiratory tract infections.

• Clinical study participants used ColdZyme or placebo at symptom onset, with viral load and symptom severity tracked over seven days.

• In vitro experiments assessed ColdZyme's ability to block viral adhesion, replication, and tissue damage in human upper respiratory tract epithelial models infected with rhinovirus.

• Swabs were collected from participants during illness to confirm infection and measure viral load.

• Optional prophylactic use of ColdZyme was allowed for participants at perceived increased risk.

Key findings and results

• ColdZyme significantly reduced the duration of upper respiratory infection episodes and rhinovirus viral load by 94% compared to placebo (P = 0.029).

• Symptom severity scores (Jackson score) and number of sick days were significantly lower in the ColdZyme group, with statistical significance across multiple symptoms.

• In vitro, ColdZyme pre-treatment reduced rhinovirus infectivity, viral load, and tissue damage in airway epithelial models.

• ColdZyme's effect extended to reducing viral loads for SARS-CoV-2 variants and Influenza A/B in previous studies.

• No significant prophylactic effect was observed in vivo, but in vitro data showed prevention of infection when ColdZyme was applied before viral exposure.

Mechanistic insights and broader implications

• Reduced viral load is the likely mechanism for shorter illness duration and milder symptoms.

• ColdZyme's effect was consistent across both in vivo and in vitro models, supporting the robustness of findings.

• The epithelial barrier and mucociliary clearance are critical in preventing infection; ColdZyme helps maintain this barrier.

• The study's design, including double-blind, placebo control, and pre-registration, ensures high scientific rigor and transparency.

• Results in athletes are expected to translate to the general population due to similar infection mechanisms.