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AiCuris Anti-infective Cures AG, corporate

AiCuris Anti-infective Cures AG,

08.07.2021 - 09:03:32

AiCuris starts its first pivotal clinical phase 3 trial with pritelivir for the treatment of HSV infections in immunocompromised subjects based on efficacy and safety data from a phase 2 trial

by US FDA for pritelivir for the treatment of mucocutaneous HSV infections in immunocompromised patients. In December 2020, the "Bundesinstitut f?r Arzneimittel und Medizinprodukte (BfArM)" acknowledged to initiate a Compassionate Use Program for pritelivir in Germany. This is part of an Early Access Program (EAP) in various countries throughout the world. Based on the results from the recent US clinical phase 2 trial, AiCuris has started a pivotal phase 3 trial as a basis for NDA submission.

About HSV

Herpes simplex viruses are widespread with a seroprevalence up to 100%, depending on geographic area and subpopulation, and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). Infections lead to lifelong persistence of the virus, with frequent and sometimes painful recurrences. While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly sexually transmitted. In immunocompromised patients, HSV can lead to serious complications. The negative stigma associated with genital herpes and visible facial lesions may cause psychological distress.

According to a publication from the World Health Organization (WHO) in 2020, an estimated 491 million people aged 15-49 (13%) worldwide were living with genital herpes caused by HSV-2. Prevalence of HSV-2 infection was estimated to be highest in Africa (44% in women and 25% in men), followed by the Americas (24% in women and 12% in men). It was also shown to increase with age, although the highest numbers of newly infected people were adolescents. While resistance is not an issue in immunocompetent hosts, infection with an acyclovir resistant HSV can become critical in immunocompromised patients leading to frequent episodes of reactivation, prolonged duration of symptoms, increased severity of infection, extensive and atypical lesions, and the risk for dissemination.

About AiCuris Anti-infective Cures AG

AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases. SANTO Holding is the Company's majority investor. PREVYMIS(R) (Letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action, was licensed to MSD in 2012 and is approved in the EU, the USA, Japan and other parts of the world for use in bone marrow transplants for the prevention of HCMV infections in adults who receive an allogeneic hematopoietic stem cell transplant. The Company is developing drugs for the treatment of viruses such as human CMV, herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses as well as for SARS-CoV-2 and other viruses with pandemic potential. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for indications with high medical need, including life-threatening, multidrug-resistant, hospital-treated pathogens.

In 2018 Dr. Holger Zimmermann, CEO of AiCuris, and Prof. Dr. Helga R?bsamen-Schaeff, Founding CEO, were awarded the German Future Prize 2018 (German President's Award for Innovation in Science and Technology) for the development of Letermovir and their project, "Protection in the Absence of the Immune System - a Life-Saving Innovation against Dangerous Viruses" (original title: "Schutz bei fehlendem Immunsystem - die lebensrettende Innovation gegen gef?hrliche Viren").

For more information, please visit www.aicuris.com. Follow us on LinkedIn.

Contacts:

Company: AiCuris Anti-infective Cures AG Katja Woestenhemke Phone: +49 202 317 63 0 Email: info@aicuris.com Media relations: MC Services AG Dr. Solveigh M?hler Phone: +49 211 529 252 19 E-Mail: aicuris@mc-services.eu

08.07.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de

1216458??08.07.2021?

@ dgap.de