WUPPERTAL, GERMANY / ACCESSWIRE / January 8, 2021 / AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, today announced that Dr. Holger Zimmermann, CEO of AiCuris, will present at the 39th Annual J.P. Morgan Healthcare Conference (11-14 Jan., 2021) on Thursday, January 14, 2021 at 08:05 am to 08:30 am Eastern Time (02:05 pm to 02:30 pm Central European Time).
“2021 is sure to be an exciting year for AiCuris. Our first product Prevymis(R) (letermovir), the first novel therapy for human cytomegalovirus (HCMV) infections since many years, which is marketed by Merck & Co., is successfully growing revenues while protecting and saving the lives of many patients worldwide. We are now preparing a pivotal Phase 3 trial with our second drug pritelivir in immunocompromised patients whose HSV infections have become resistant to acyclovir. This will form the basis for our next NDA submission, targeting approval in 2023,” said Dr. Holger Zimmermann, CEO of AiCuris. “In the area of infectious diseases there are a lot of indications with a strong need for new efficient solutions. Finding these solutions is one of our main priorities. Last year we launched our PREP campaign – Pandemic and Resistance Emergency Preparedness, to tackle worldwide health threats resulting from upcoming pandemics and antimicrobial resistance (AMR). We plan to initiate a clinical trial with AIC649 for the prevention of COVID-19 and other upcoming infections with pandemic potential. With these developments, there is a lot to look forward to with AiCuris in 2021 and beyond.”
The AiCuris management will be available for 1:1 meetings. Interested parties can schedule a meeting via the J.P. Morgan platform at https://events.jpmorgan.com/#/?_k=6hty6s or by sending an email to email@example.com.
Status of Infectious Diseases Pipeline – Solving the Needs of Today:
In 2017 Prevymis(R) (letermovir) a principal new therapy for human cytomegalovirus (HCMV) was brought to the market via AiCuris’ global partner Merck & Co. to treat patients that are undergoing bone marrow transplantation. Letermovir is also being developed for further indications. A pivotal study for HCMV prophylaxis in kidney transplant recipients is currently ongoing. The product is successfully growing revenues and AiCuris is anticipating blockbuster potential.
AiCuris is preparing a pivotal Phase 3 trial with pritelivir in immunocompromised patients whose HSV infections have become resistant to acyclovir. Pritelivir is an innovative, highly active and specific inhibitor of herpes simplex virus (HSV) with a novel mode of action that is distinct from other antiviral agents currently in use for treating HSV infections. Derived from a novel chemical class (thiazolylamides), pritelivir is active against both types of herpes simplex virus (HSV-1 and HSV-2), causing labial and genital herpes, and retains activity against viruses which have become resistant to marketed drugs. Pritelivir showed superiority against standard treatment valacyclovir in a clinical Phase 2 trial in patients with genital HSV-2 infection. In June 2020, AiCuris was granted Breakthrough Therapy Designation by U.S. FDA for pritelivir for the treatment of HSV infections in immunocompromised patients, and in December 2020, the German “Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)” approved the initiation of a Compassionate Use Program as part of an Early Access Program (EAP) operated by myTomorrows.
AiCuris is focusing on both viral and bacterial areas of unmet medical need, exploring the areas of HSV therapy for immunocompromised patients, chronic HBV cure, and adenoviral infections. Focus in bacteriology is on fighting gram-negative resistant bacterial infections with novel approaches. With this strong portfolio of compounds AiCuris aims to address various unmet needs in the antiinfective field.
Pandemic and Resistance Preparedness – Preparing for Future Threats:
Along with existing problems potential future threats should not be underestimated. The global COVID -19 pandemic, caused by a newly discovered coronavirus, SARS-CoV-2, has taught us that we must prepare for the worst in order to prevent future pandemics. While scientists are working to understand and control the COVID-19 pandemic, it is also crucial to prepare for potential future, viral pandemics but also on infections caused by resistant bacteria (AMR).
AiCuris has discovered a novel biological immunomodulator, AIC649, a proprietary inactivated parapoxvirus particle preparation. AIC649’s ability to boost the immune system against unrelated viruses gives the compound the potential to act as a broad, first-line therapy for current and future pandemics. AiCuris is currently preparing for a clinical pilot trial to test its AIC649 compound as first-line therapy against Corona viruses.
AiCuris is one of the few European companies that since inception is highly focused on developing novel, effective anti-infective agents with novel mechanisms of action that overcome resistance. In July 2019, for example, AiCuris signed a long-term cooperation for the development and optimization of Artilysin(R)-based drug candidates for various anti-bacterial indications including e.g. hospital-acquired pneumonia, and sepsis with Lysando AG. Thus, AiCuris has the experience and financial strengths to remain committed to attack antibiotic resistance in new ways.
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 Dr. Holger Zimmermann, CEO of AiCuris, and Prof. Dr. Helga Rübsamen-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 gefährliche Viren”).
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