It's certainly amateur hour .... who wrote or signed off on this section in the report ? It starts off with 4 paragraphs on Viraleze™ and then jumps to 3 on VivaGel® BV and then jumps back to 2 on Viraleze™ ..... talk about inconsistent ? Clumsy to say the least
Starpharma recently announced the results of the post-market clinical study of Viraleze™ nasal spray in participants with COVID-19. The results showed that Viraleze™ reduced SARS-CoV-2 viral load and increased the rate of virus clearance from the nose, and in parallel, improved key symptoms of COVID-19, including loss of smell (anosmia), and was well-tolerated.
Viraleze™ achieved a statistically significant reduction in SARS-CoV-2 viral load, the primary endpoint of the study, in the cohort of participants aged 45 and over (N=118, p=0.017). Viraleze™ reduced viral load in the full study population including all patient age groups (N=197), although the difference vs placebo was not statistically significant.
The results from this study provide significant clinical evidence of the performance of Viraleze™ in humans that will support regulatory processes for the transition to the new European Medical Device Regulations (MDR), which will come into full effect in 2029. The positive data will also support ongoing marketing and commercial activities for the product.
In this clinical study, the benefits of Viraleze™ were more pronounced in older participants and have potential relevance to older individuals who are typically more susceptible to respiratory infection and disease. These findings are consistent with Starpharma’s nonclinical in vivo and in vitro studies of Viraleze™ in SARS-CoV-2 and other cold/respiratory viruses, including influenza, and provide further support for Viraleze™ in helping to protect against respiratory infection and disease. Reduced viral load and increased viral clearance have the potential to protect against infection, improve symptoms, and reduce onward transmission.
In January 2024, Starpharma signed a sales and distribution agreement for its VivaGel® BV product with ITROM Pharmaceutical Group, covering 13 countries across the Middle East and North Africa (MENA). ITROM specialises in introducing new pharmaceutical products to the MENA region and has a proven track record of successfully launching and growing the market share of new pharmaceutical products in multiple therapeutic areas within its region. The prevalence of bacterial vaginosis among a female population of 238 million in the MENA region is 25%, indicating a high need for new effective therapeutic approaches and a significant opportunity for VivaGel® BV. This new partnership with ITROM follows the recent reversion of VivaGel® BV rights to Starpharma under a settlement agreement with Mundipharma, announced in August 2023. Starpharma has now commenced the transferral processes for the existing VivaGel® BV registrations.
As foreshadowed at Starpharma’s Annual General Meeting in November 2023, Starpharma lodged a further VivaGel® BV submission to the US Food and Drug Administration (FDA) during Q2 FY24. Starpharma has since also met with the FDA to discuss this submission. Starpharma will provide an update on this submission upon receiving an outcome from the FDA.
Starpharma’s partner, Aspen, continues to market VivaGel® BV in Australia and New Zealand; Fleurstat BVgel is the top-selling BV treatment by sales in Australia.
Starpharma continues to market Viraleze™ through Amazon UK and a dedicated product website. Starpharma also has commercial partners in several international markets, where the product is distributed online and in retail outlets, including pharmacies. The Company continues to pursue additional commercial opportunities for the product.
Viraleze™ is not approved for use or supply in Australia, where the review by the Therapeutic Goods Administration (TGA) for the SPL7013 nasal spray as a medical device is ongoing.
SPL Price at posting:
15.0¢ Sentiment: Buy Disclosure: Held
(20min delay)