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 News Release - May 5, 2020

Acesion Pharma Strengthens Clinical Team With Key Appointments

Appoints experienced Chief Medical Officer and Director Clinical Operations

COPENHAGEN, Denmark, May 5, 2020 -- (Healthcare Sales & Marketing Network) -- Acesion Pharma, a Danish pharmaceutical company developing novel treatments for atrial fibrillation (AF), the most common cardiac arrhythmia, today announced that it has recruited Anders Gaarsdal Holst as its Chief Medical Officer (CMO) to succeed Nils Edvardsson, who will continue to support the company as Medical Adviser. In addition, Acesion Pharma has further strengthened the clinical team by recruiting Birgitte Vestbjerg as Director Clinical Operations.

As CMO, Anders will lead the development efforts of the company's entire product portfolio. Anders joins Acesion from Novo Nordisk A/S, where, as Senior International Medical Director he contributed to Novo Nordisk's cardiovascular clinical development. He held key roles in several project management governance teams and gained broad clinical development experience also in areas including Safety, Regulatory Affairs and CMC (Chemistry, Manufacturing and Control). Anders has a prolific scientific track-record with over one hundred research publications on cardiac arrhythmias, particularly atrial fibrillation. Anders completed his PhD at the department of Cardiology at Rigshospitalet in Copenhagen.

Birgitte Vestbjerg has led and run international clinical studies and operations for both small and large companies for over 20 years. Birgitte has a background in nursing in Intensive and Cardiovascular care and has been Clinical Research Coordinator for several cardiovascular trials in Denmark and the United States.

Frans Wuite, Chief Executive Officer of Acesion Pharma, commented: "We are delighted to have Anders and Birgitte onboard at an important time for the company, as our lead product is being studied in a Phase II Proof-of-Concept trial validating our therapy platform based on a novel mechanism of action. Anders has a profound understanding of the underlying science and extensive experience from developing and running a corporate cardiovascular program with several international trials.

"We are also very pleased to have an experienced professional like Birgitte to lead our clinical operations, as our iv-cardioversion product is already in Phase II and our oral products are rapidly progressing towards the clinic."

Acesion's novel approach is based on inhibition of SK channels - ion channels present in the atria that play a role in regulating the cardiac rhythm. Blocking these ion channels with a functionally atrial selective drug helps avoid deleterious effects on the ventricles. Targeting the SK channels thereby constitutes a novel and promising approach for an effective treatment for AF with an expected higher safety and tolerability profile.

Following a successful Phase I study in healthy volunteers in 2018, Acesion is currently conducting a Phase II study to obtain clinical proof-of-concept for an IV-formulation of its cardioversion drug AP30663 to convert AF into normal sinus rhythm in hospitals. An oral formulation of this drug for cardioversion outside hospitals will start clinical trials next year, followed by an SK-inhibitor for oral maintenance therapy in 2022.

About Acesion Pharma

Acesion's novel platform is based on inhibition of SK-channels, a target that is predominantly expressed in the atria. This allows for selective treatment of atrial fibrillation aiming at improved efficacy and safety. Acesion's first product AP30663 is a short acting cardioversion therapy with an iv-formulation for hospitals followed by an oral formulation for treatment in open care. It is currently in Phase II trials. In addition, Acesion has selected AP31742 as its development candidate for prevention of atrial fibrillation (maintenance therapy). AP31742 will enter safety and toxicity studies early next year.

Acesion Pharma is backed by Novo A/S, Wellcome Trust, Broadview Ventures and FC Capital.

www.acesionpharma.com

About atrial fibrillation (AF)

AF is the most common type of cardiac arrhythmia and is characterized by an irregular and abnormally high frequency in the upper chambers of the heart, the atria. AF is associated with impaired quality of life, increased rate of hospitalization, and a 4-5 fold increased risk of stroke and death. Increasing evidence suggests that patients with AF also face a higher risk of cognitive dysfunction and dementia. 40 % of patients with AF without a history of stroke, have been shown to have brain damage of unknown origin. AF mainly affects the elderly population, and it is estimated that up to 6 million people in the US and over 10 million people in the EU suffer from AF. Lifetime risk for development of AF is estimated at 1 in 4 at age 40 years and older. Due to increasing age of the population and an increase of lifestyle related diseases, the number of AF patients is expected to rapidly increase.

Atrial Fibrillation is often treated by electrical shock to bring the heart back to its normal rhythm (cardioversion). This requires general anesthesia in a hospital setting. Existing drug therapies for cardioversion or prevention of atrial fibrillation have limited efficacy and/or are often associated with risk of serious cardiac or other adverse effects. Therefore, there is a great need for safer drugs to treat this condition.


Source: Acesion Pharma

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