AiCuris collaborates with myTomorrows to initiate an Early Access Program for Pritelivir
- The Early Access Program may provide access to pritelivir for use in immunocompromised patients that have acyclovir-resistant mucocutaneous herpes simplex virus infections
- An Early Access Program offers a method to provide patients with an unmet medical need with possible access to medication currently not licensed in their home country
WUPPERTAL, GERMANY and AMSTERDAM, NETHERLANDS / ACCESSWIRE / February 12, 2020 / AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases and myTomorrows, a Netherlands-based HealthTech company facilitating access to medicines in development and real-world data collection, today announced a collaboration to develop an Early Access Program (EAP) for pritelivir, currently undergoing Phase II testing for treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.
“Especially in immunocompromised patients, HSV can lead to serious complications,” said Dr. Holger Zimmermann, CEO of AiCuris. “Our collaboration with myTomorrows may help provide patients with an unmet medical need with access in their home country to a potential treatment option.”
EAPs offer a method to provide treatment with medication currently not licensed in a patient’s country of residence. Eligible patients for an EAP have a high unmet medical need, cannot participate in a clinical trial, and have exhausted all registered treatment options.
“I am delighted that AiCuris is partnering with myTomorrows to develop this Early Access Program,” said Steve Glass, COO of myTomorrows. “With our unique online platform and our global capabilities of supporting early access and real-world data collection, we aim to facilitate access to medicines in development for patients who have high unmet medical need.”
Pritelivir is an investigational drug that inhibits herpes simplex virus replication. In 2017, AiCuris was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for pritelivir for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised adults.
About HSV infections
Herpes simplex viruses are widespread (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. The negative stigma associated with genital herpes may cause psychological distress. In immunocompromised patients, HSV can be severe and persistent and can lead to serious complications. Immunocompromised patients have a weakened immune system, which is caused by certain medical treatments or illnesses. This means they have a reduced ability to fight infections and other diseases.
About Early Access Programs
An Early Access Program (EAP), also known as Expanded Access Program or Managed Access Program, supports in a compliant and controlled way the treatment with a medicine currently not licensed in a patient’s country of residence. Such treatment can be an option for patients who have high unmet medical need, have exhausted all registered treatment options and cannot participate in a clinical trial.
About AiCuris Anti-infective Cures GmbH
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. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for life-threatening, multidrug-resistant, hospital-treated pathogens.
In 2018 Prof. Dr. Helga Rübsamen-Schaeff, Founding CEO, and Dr. Holger Zimmermann, CEO of AiCuris, 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 gefährliche Viren”).
myTomorrows operates as a two-sided platform. It serves the interests of both patients and healthcare providers, as well as drug development. On one side, the company provides information on all treatment options to patients and physicians when registered treatments have been exhausted. On the other side, myTomorrows is specialized in early access regulations and administration and real-world data collection, evolving scientific clinical development. myTomorrows has gained experience in running over 25 EAPs over the past 5 years, in more than 40 countries across 5 continents. For more information, please visit www.mytomorrows.com.
myTomorrows directly engages with physicians and patients. Requests for access may come in directly to myTomorrows by phone, email, or through an online portal. Physicians and patients will be directed to a member of our Medical team who will guide them through the access process. The response time for an inquiry is no longer than one business day.
For inquiries about myTomorrows or Early Access, please contact our medical team via firstname.lastname@example.org.
AiCuris Anti-infective Cures GmbH
Michel van Harten, CMO
MC Services AG
SOURCE: AiCuris Anti-infective Cures GmbH via EQS Newswire
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