A Closer Look at Viraleze’s Potential in Combatting SARS-CoV-2
Our source has recently highlighted that the nasal spray, Viraleze, exhibits considerable promise in the global battle against SARS-CoV-2. Following a scrupulous double-blind, placebo-controlled study involving 222 safety analyses participants, the results rendered were especially favourable for individuals aged 45 and above.
Assessing Viral Load Reduction
Participants of the study were directed to apply Viraleze four times daily for a week. The outcome was notably promising: within the first 24 hours of administering the dose, an 80% reduction in viral load was observed in participants aged 65 and above, achieving the primary endpoint. A decrement in the viral load was identified across all age groups, however, when contrasted with the placebo, the figures were not statistically significant.
Consistency with Earlier Studies
The results of these post-market investigations are coherent with previous non-clinical studies. It is anticipated that these findings will strengthen Viraleze’s regulatory intake in the European Union. The nasal spray has demonstrated its effectiveness in lowering the SARS-CoV-2 viral load in the nasal canal, accelerating the rate of virus elimination, and mitigating core COVID-19 symptoms, such as anosmia. Consequently, definitive clinical evidence of Viraleze’s performance has emerged, further enhancing the product’s marketing and commercial operations.
What’s Next in Line?
Over and above, the Phase I/II trial of NTI164 for paediatric patients diagnosed with Spastic Diplegia Cerebral Palsy at the Monash Medical Centre is projected to commence shortly. The center of attention in this trial will squarely be on the health-related quality of life, in conjunction with the impact on caregivers. PharmAust, in the meantime, has engaged in discussions with the Food and Drug Administration (FDA), with their Orphan Drug Designation (ODD) application for MPL in treating MND/ALS in focus. The FDA has stipulated additional pre-clinical or clinical data to substantiate MPL’s efficacy. They have paved the way for PharmAust to reconfigure their ODD application with supplementary data, incorporating the upcoming top-line results from their Phase I MEND Study.
