On Friday, Barinthus Biotherapeutics plc BRNS, formerly Vaccitech plc, released topline final data from the APOLLO trial (HPV001) Phase 1b/2 dose-ranging trial of VTP-200 in women with low-grade cervical lesions associated with persistent High-risk human papillomavirus (hrHPV) infection.
“While we didn’t observe a significant improvement from VTP-200 in the overall pooled results, we did observe positive trends in the highest dose cohorts,” said Bill Enright, CEO.
The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited AEs and no treatment-related SAEs.
The highest hrHPV clearance rate of 60% at Month 12 was observed in group 2, which included the highest dose of ChAdOx, compared to a 33% clearance rate in the placebo group. Groups 1, 3, 4, and 5 showed 12%, 11%, 33%, and 36% hrHPV clearance rates, respectively.
The study also evaluated cervical lesion clearance rates in participants with both reported lesions at screening and visualization of the cervical transformation zone at 12 months (n=57).
The highest cervical lesion clearance rate, 67%, was observed in group 2 and group 5, both of which received the highest dose of ChAdOx, compared to 39% in the placebo group. Groups 1, 3, and 4 showed 40%, 20%, and 33% cervical lesion clearance rates, respectively.
Pooled data from the five active dose groups showed no significant improvement in hrHPV clearance or cervical lesion clearance rates compared to the placebo group.
Future development options for the VTP-200 program are being evaluated with ongoing analyses.
“However, these differences compared to placebo were not statistically significant given that the trial was not powered for individual dose group comparisons,” said Nadege Pelletier, Chief Scientific Officer of Barinthus Bio.
William Blair analyst expects investors to find the recent VTP-200 data update disappointing and highlights that significant investment and time may be needed to fully capitalize on the program’s value.
Consequently, attention may shift towards VTP-300, currently being explored as a treatment for chronic hepatitis B infection. Further results are expected in the second quarter.
William Blair notes that given that about one-third of patients naturally clear high-risk HPV infections, it’s important to see a strong and consistent trend to build investor confidence in the program’s future potential.
Price Action: BRNS shares are trading lower by 5.90% at $2.71 at the last check Friday.
PublicDomainPictures from Pixabay
