EXCIVA GmbH Company Profile

Background

Founded in 2016 and headquartered in Heidelberg, Germany, EXCIVA GmbH is a biopharmaceutical company dedicated to developing innovative treatments for behavioral and psychological symptoms associated with Alzheimer's disease and other dementias. The company's mission is to integrate molecular, behavioral, and chemical technologies to address these complex symptoms, aiming to improve patient outcomes and quality of life.

Key Strategic Focus

EXCIVA's strategic focus centers on the development of novel therapeutic compounds targeting behavioral and psychological symptoms in Alzheimer's patients, such as agitation and aggression. The company's lead candidate, Deraphan®, combines two clinically validated compounds that have demonstrated efficacy in the central nervous system (CNS). This approach leverages existing safety profiles to expedite development timelines and address significant unmet medical needs in the Alzheimer's treatment landscape.

Financials and Funding

In October 2021, EXCIVA secured a €9 million Series A financing round led by Andera Partners, with participation from LBBW Venture Capital and Cure8. This funding is intended to advance the development of Deraphan® through the completion of Phase I clinical trials, with the goal of initiating Phase II trials in the near future.

Pipeline Development

EXCIVA's lead compound, Deraphan®, is a combination therapy designed to treat behavioral and psychological symptoms in Alzheimer's disease. The company successfully completed a Phase I study of its proprietary EXV-802 combination in October 2022, demonstrating safety and tolerability. Plans are underway to commence Phase II trials to further assess efficacy and safety in a larger patient population.

Technological Platform and Innovation

EXCIVA employs a Targeted Drug Rescue (TDR) approach, focusing on repurposing and combining existing compounds with known safety profiles to create novel therapies. This strategy integrates molecular, behavioral, and chemical technologies to develop treatments that address both neurological and psychological aspects of Alzheimer's disease. The company's proprietary combination therapy, Deraphan®, exemplifies this innovative approach by combining two CNS-active compounds to target complex behavioral symptoms.

Leadership Team

François Conquet, Ph.D. – Chief Executive Officer & Managing Director: Dr. Conquet brings extensive experience in the biotech industry, having previously founded Prexton Therapeutics. His leadership is instrumental in guiding EXCIVA's strategic direction and development programs.

Francisco Orellana – Chief Financial Officer: With over twenty years in the biotech sector, Mr. Orellana joined EXCIVA in June 2023, overseeing financial operations and strategic financial planning.

Dr. Hans Moebius – Chief Medical Officer: A co-founder of EXCIVA, Dr. Moebius assumed the role of CMO in April 2024, bringing over thirty years of leadership in neurology and psychiatry drug development and translational medicine.

Nadine Knowles – Head of Clinical Operations: Ms. Knowles joined EXCIVA in December 2022, offering over thirty years of experience in clinical trial operations, particularly in studies focusing on agitation in Alzheimer's disease dementia.

Leadership Changes

Recent significant appointments include:

April 2024: Dr. Hans Moebius, co-founder, assumed the role of Chief Medical Officer.

June 2023: Francisco Orellana joined as Chief Financial Officer.

December 2022: Nadine Knowles appointed as Head of Clinical Operations.

Competitor Profile

Market Insights and Dynamics

The global Alzheimer's disease therapeutics market is experiencing significant growth, driven by an aging population and increasing prevalence of the disease. There is a substantial unmet need for effective treatments, particularly for behavioral and psychological symptoms, which affects a large proportion of patients and poses challenges for caregivers and healthcare systems.

Competitor Analysis

Key competitors in the Alzheimer's therapeutics space include:

Biogen Inc.: Focuses on disease-modifying therapies, notably with the development and approval of aducanumab, targeting amyloid-beta plaques.

Eli Lilly and Company: Engages in developing treatments targeting amyloid and tau proteins, with several candidates in various stages of clinical development.

Roche Holding AG: Invests in a diverse pipeline addressing multiple aspects of Alzheimer's pathology, including monoclonal antibodies and small molecules.

Axsome Therapeutics: Develops therapies targeting CNS disorders, including agitation associated with Alzheimer's disease, with candidates in advanced clinical stages.

These companies employ various technologies, including monoclonal antibodies, small molecules, and combination therapies, aiming to modify disease progression or alleviate symptoms. The competitive landscape is characterized by a mix of large pharmaceutical companies and specialized biotech firms, each contributing to the evolving treatment paradigm for Alzheimer's disease.

Strategic Collaborations and Partnerships

EXCIVA's strategic partnerships include:

Andera Partners: Led the €9 million Series A financing round, providing financial support and strategic guidance.

LBBW Venture Capital and Cure8: Participated in the Series A round, contributing to the advancement of EXCIVA's clinical programs.

These collaborations enhance EXCIVA's market position and innovation capacity, facilitating the development and potential commercialization of its lead compound, Deraphan®.

Operational Insights

EXCIVA's strategic considerations include:

Differentiation: By focusing on the repurposing and combination of existing compounds with known safety profiles, EXCIVA aims to expedite development timelines and reduce regulatory risks.

Market Position: Targeting the significant unmet need for treatments addressing behavioral and psychological symptoms in Alzheimer's disease positions EXCIVA uniquely in the market.

Competitive Advantages: The company's innovative Targeted Drug Rescue approach and experienced leadership team provide a strong foundation for success in the competitive Alzheimer's therapeutics landscape.

Strategic Opportunities and Future Directions

EXCIVA's strategic roadmap includes:

Advancing Clinical Development: Progressing Deraphan® through Phase II and subsequent clinical trials to demonstrate efficacy and safety.

Regulatory Engagement: Collaborating with regulatory agencies to facilitate the approval process for Deraphan®.

Market Expansion: Exploring partnerships and commercialization strategies to bring Deraphan® to global markets, addressing the widespread need for effective Alzheimer's treatments.

Pipeline Diversification: Leveraging the TDR approach to identify and develop additional therapeutic candidates for CNS disorders.

Contact Information

For more information, visit EXCIVA's official website: www.exciva.com

Note: Specific contact details such as address, phone number, and email are not provided in this profile.