On Monday, AstraZeneca plc AZN entered into an exclusive license agreement with Hong Kong-based CSPC Pharmaceutical Group Ltd to advance the development of an early-stage, novel small-molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia.
Dyslipidemia is a metabolic disorder that occurs when there are abnormal levels of lipids or fats, such as cholesterol and triglycerides, in the blood.
Under the terms of the agreement, AstraZeneca will receive access to CSPC's pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, to develop the lipid-lowering therapy with potential in a range of cardiovascular disease indications alone or in combination, including with the oral small molecule PCSK9 inhibitor, AZD0780.
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YS2302018 was discovered by CSPC and has been shown to prevent the formation of Lp(a).
Lp(a) is a form of low-density lipoprotein (LDL) that plays a key role in cholesterol transport in the bloodstream.
Elevated levels of Lp(a) and elevated LDL cholesterol are known risk factors for cardiovascular disease.
CSPC will receive an upfront payment of $100 million from AstraZeneca and is eligible to receive up to $1.92 billion for further development and commercialization milestones, plus tiered royalties.
On Monday, AstraZeneca released topline data from BATURA Phase 3b trial of inhaled Airsupra (albuterol/budesonide) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.
The study met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of severe exacerbation.
The trial included patients with intermittent or mild persistent asthma.
Asthma affects as many as 262 million people worldwide, including over 25 million in the U.S.
Patients with mild asthma comprise at least 50% of the U.S. asthma population and are at risk of severe exacerbations.
Airsupra is the first and only anti-inflammatory rescue medication approved in the U.S. for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.
The US approval was based on MANDALA and DENALI Phase 3 trial results.
Airsupra is also being studied in adolescents with asthma in the ACADIA Phase 3 trial and in patients in China in the BAIYUN Phase 3 trial.
Price Action: AZN stock is down 0.68% at $76.94 during the premarket session at last check Monday.
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