Enterprise Therapeutics Appoints Annabella Amatulli as Head of Regulatory Affairs
Key Insights
Enterprise Therapeutics (search) has appointed Annabella Amatulli as Head of Regulatory Affairs to bolster its strategic leadership team.
Amatulli will spearhead regulatory strategy, focusing on the Phase 2 clinical trial of ETD001 for cystic fibrosis (search) (CF) patients not benefiting from CFTR modulators.
Her extensive experience includes securing Orphan Drug Designation and Breakthrough Therapy approvals from EMA, FDA, MHRA, and NMPA.
Enterprise Therapeutics (search) Ltd has announced the appointment of Annabella Amatulli as its new Head of Regulatory Affairs. Amatulli's arrival is particularly timely as the company's lead asset, ETD001, progresses through its Phase 2 clinical trial for the treatment of cystic fibrosis (search) (CF). Her role will be pivotal in navigating the regulatory landscape and supporting the clinical, medical, and market access teams.
Amatulli brings over 14 years of pharmaceutical regulatory experience to Enterprise Therapeutics (search). Before joining Enterprise, she served as Head of Global Regulatory Sciences at Alfasigma, where she contributed to the company's growth and regulatory strategy across various development phases. Her experience spans Europe, the US, and other global regions, and she has interacted with health authorities such as the EMA, FDA, MHRA, and NMPA.
Focus on ETD001 and Novel Therapies
Annabella's primary focus will be on supporting the Phase 2 clinical trial of ETD001, a novel long-acting ENaC (search) blocker. ETD001 holds promise for treating individuals with cystic fibrosis (search) who do not currently benefit from CFTR modulator therapies. In addition to ETD001, Amatulli will define regulatory pathways for Enterprise Therapeutics (search)' pipeline of other novel low molecular weight compounds, which have first-in-class and best-in-class potential.
Leadership Perspectives
"We welcome Annabella as Head of Regulatory Affairs," said Dr. John Ford, CEO of Enterprise Therapeutics (search). "Her broad experience in managing regulatory teams and liaising with health authorities will be hugely beneficial as we continue to progress our respiratory therapeutics programs. Annabella’s expertise will prove especially valuable as we transition through Phase 2 clinical trials for our lead asset ETD001, moving closer to providing a novel treatment for all people with CF, including those with the highest unmet medical need."
Annabella Amatulli herself stated, "I am delighted to join Enterprise at such a pivotal time. The work that the Company is doing has the potential to vastly improve the lives of people with respiratory diseases. I look forward to working with the leadership team to help drive the continued development of the pipeline."