- Avillion LLP announces positive topline results from the MANDALA and DENALI Phase 3 trials of PT027 in asthma patients.
- PT027 is an inhaled, fixed-dose combination of albuterol and budesonide developed by AstraZeneca Plc (NASDAQ:AZN) and Avillion.
- The trials met all primary endpoints at both 180/160mcg and 180/80mcg doses and demonstrated statistically significant benefits versus individual albuterol and budesonide components.
- The PT027 clinical co-development program was funded by Blackstone Life Sciences, Royalty Pharma (NASDAQ:RPRX), and Abingworth.
- The MANDALA trial demonstrated statistically significant and clinically meaningful reductions in the risk of severe exacerbations compared to albuterol when used as a rescue medicine in response to symptoms.
- The trial included 3,132 patients taking maintenance inhaled corticosteroid (ICS) with or without additional controller medicines.
- The DENALI trial showed a statistically significant improvement in lung function compared to the individual components and placebo.
- The trial included 1,001 patients previously treated either with a SABA as needed alone or in addition to low-dose maintenance ICS therapy.
- The safety and tolerability of PT027 in both trials were consistent with the known profiles of the components.
- Detailed data from the trial will be presented at an upcoming medical meeting.
- Price Action: AZN shares are down 0.54% at $56.76 during the premarket session on the last check Thursday.
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The Dow traded up 0.03% to 33,708.20 while the NASDAQ fell 0.79% to 11,762.38. The S&P 500 also fell, dropping, 0.51% to 4,069.49.
