AstraZeneca announced on Thursday that its Fasenra asthma therapy used in the treatment for a chronic inflammatory disease of the nasal passage linings, or sinuses met both co-primary endpoints in a late-stage trial.
Shares are gaining 2.2% in Thursday’s pre-market trading. AstraZeneca (AZN) said that high-level results from the Phase 3 trial showed that Fasenra (benralizumab) compared with placebo demonstrated a statistically “significant improvement” in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
CRSwNP is characterised by persistent inflammation of the mucous membrane lining the nasal passages and sinuses accompanied by benign growths, called nasal polyps. Nasal polyps can block nasal passages and lead to breathing problems, reduction in the sense of smell, nasal discharge, sleep disturbance and other adverse effects.
“Patients with chronic rhinosinusitis with nasal polyps suffer significantly with nasal congestion and a reduced quality of life. Current treatments, such as intranasal or oral corticosteroids and surgery to remove polyps, do not fully address patient needs,” said AstraZeneca’s Mene Pangalos. “The data indicate Fasenra can benefit patients with nasal polyps. We look forward to completing the full analysis and sharing these results at an upcoming medical meeting.”
More specifically, Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score (NPS) and the nasal blockage score (NBS) compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care (SoC). SoC consists of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids.
The safety profile and tolerability of Fasenra in this trial were consistent with the known profile of the medicine, AstraZeneca said. Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries and is approved for self-administration in the US, EU and other countries.
AZN shares have gained 7.6% this year as the drugmaker joined the list of companies engaged in the development of a potential coronavirus vaccine. The Phase 2/3 study of the AstraZeneca/Oxford vaccine candidate was this week put on hold after an adverse event in a single participant from the UK. (See AstraZeneca stock analysis on TipRanks)
In reaction, SVB Leerink analyst Andrew Berens reiterated a Buy rating on the stock suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca's shares as well as in the stock of other companies with COVID vaccine programs until the exact nature of the event is clear.
As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.
Overall, the stock scores a Strong Buy consensus from the analyst community with 4 unanimous Buy ratings. Looking ahead, the $81.17 average analyst price target puts the upside potential at a promising 51% in the coming 12 months.
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