AiCuris GmbH & Co. KG

WUPPERTAL, Germany I October 31, 2024 I AiCuris Anti-infective Cures AG today announced the initiation of its Phase 1, first-in-human trial of AIC468, a novel antisense oligonucleotide. AIC468 is an antiviral agent which aims to treat BK virus (BKV) infections in kidney transplant (KT) recipients. BKV reactivation in KT recipients is an area of high unmet medical need with no approved drug treatments. This Phase 1 trial ( 2023-510074-13-00 ) will evaluate the safety, tolerability and pharmacokinetics of AIC468 in healthy volunteers. “BK virus infections remain an urgent threat to transplant recipients, leading to graft loss and other serious complications,” said Cynthia Wat, MD, CMO of AiCuris . “Advancing AIC468 into clinical trials brings us one step closer to providing a targeted therapeutic option that directly inhibits BK virus replication, that addresses this critical unmet medical need. Our team remains committed to improving outcomes for patients dealing with the challenges of post-transplant viral infections.” “This trial marks another significant milestone in our mission to develop innovative therapies for patients with weakened immune systems, who are particularly vulnerable to serious viral infections like BK virus infections,” said Larry Edwards, CEO of AiCuris . “The initiation of this trial demonstrates the strength and diversity of our pipeline as we continue to advance cutting-edge solutions for high-risk patient populations. With multiple programs now in the clinic, we are confident that our approach can make a meaningful impact on the lives of immunocompromised patients.” The randomized, double-blind, placebo-controlled first-in-human trial will assess the safety, tolerability, and pharmacokinetics of AIC468 in 72 healthy volunteers. Conducted in Germany, the trial includes both single and multiple ascending doses of AIC468. Topline data readout from the single ascending dose part of the study is expected in 2025. About BKV BK virus (BKV) is a common polyomavirus that infects most people in early childhood, typically without symptoms. In immunocompromised individuals, such as organ transplant recipients, BKV can reactivate, leading to serious health issues. In kidney transplant (KT) patients, BKV reactivation can cause BK virus-associated nephropathy (BKVAN), affecting up to 10% 1 of recipients and potentially resulting in graft loss. Current management involves reducing immunosuppressive therapy, which increases the risk of graft rejection. Despite its prevalence, there is no approved antiviral treatment specifically for BKV. About AiCuris AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS ® , marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future. 1 Imlay H. et al., Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials, Clinical Infectious Diseases , 2022, https://doi.org/10.1093/cid/ciac071 SOURCE: AiCuris

GSK is ending further development of its therapeutic vaccine for herpes after the candidate failed to prevent recurrent symptom flare-ups in infected adults in a mid-phase trial. The vaccine, known as GSK3943104, is currently the only asset for herpes in GSK’s infectious disease pipeline. It is designed to prevent outbreaks of genital sores or blisters in people who already carry the virus. The candidate did not meet the Phase 2 primary efficacy endpoint of time until the first confirmed herpes simplex virus type 2 (HSV-2) episode versus placebo in the Phase 1/2 proof-of-concept study, according to a Wednesday release . The Phase 2 portion was evaluating the asset in 240 people aged 18 to 60 with recurrent genital herpes with at least three episodes in the past year, according to a company presentation . GSK said it will continue with routine safety monitoring of the patients involved, but no longer plans to advance the program through Phase 3 studies. But the company said it will use findings from the failed study to support future R&D efforts in the disease. Genital herpes is often caused by HSV-2, which affects around 491 million people worldwide, according to the WHO. There is no cure, but available treatments can help prevent or shorten outbreaks or reduce the risk of passing the infection on to sexual partners. HSV-2 has also been linked with an increased risk of developing cervical cancer. In May, Moderna announced it had completed enrollment of 300 people into its Phase 1/2 trial of mRNA-1608 in adults with recurrent HSV-2 genital herpes. BioNTech kicked off a Phase 1 test of its prophylactic candidate back in 2022. Creating new vaccines and treatments for herpes has also been the target of smaller biotechs. Germany’s AiCuris has an antiviral candidate dubbed pritelivir in Phase 3 trials for immunocompromised people with resistant forms of HSV. Meanwhile, Woburn, MA-based Rational Vaccines is taking a more traditional approach by developing attenuated live viral vaccines for the infection.

WUPPERTAL, Germany--( BUSINESS WIRE )-- AiCuris Anti-infective Cures AG announced today the appointment of Cynthia Wat, MD as Chief Medical Officer, effective July 1, 2024. Dr. Wat is a highly accomplished pharmaceutical physician with over 25 years of experience in delivering novel treatments to patients with infectious diseases. Her proven track record of designing and executing successful clinical development strategies from early to late-stage development and through market licensure, will benefit the company as it prepares to advance its Phase 3 product candidate pritelivir towards market authorization. Pritelivir is AiCuris’ innovative therapeutic candidate inhibiting HSV replication which is currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. As part of her role, Dr. Wat will be responsible for the management and global development of AiCuris' clinical pipeline of innovative therapeutic candidates aiming to improve the lives of immune compromised patients. AiCuris also provided an update on further leadership team changes. Holger Zimmermann, PhD, has stepped down from his position as Chief Research and Development Officer to pursue other opportunities. Dr. Zimmermann was part of the spin-out in 2006 which became AiCuris, served as AiCuris CEO from 2015 to April 2023 and was key contributor in the discovery and development of letermovir which was out-licensed to MSD in 2012 and is currently marketed as PREVYMIS ® . “As we complete patient enrollment in our pivotal Phase 3 study with pritelivir in the first half of 2025, Cynthia’s extensive experience in product filing and negotiating with global health authorities will be vital to rapidly and successfully position our lead candidate for commercialization,” said Larry Edwards, CEO of AiCuris . “I am looking forward to working with Cynthia as we continue to execute on our mission of providing multiple therapeutic solutions for immunocompromised patients in a more efficient and effective manner. On behalf of the AiCuris team, I also would like to sincerely thank Holger for his invaluable support since the inception of the company and his contributions over the years. We wish him all the best for his future endeavors.” “Joining AiCuris presents a unique opportunity to rapidly and effectively deliver innovative therapies to immunocompromised individuals. The company is one of the few private biotech companies that successfully developed a commercial-stage drug that is improving the lives of thousands of seriously ill patients. Its differentiated pipeline candidates hold the potential to deliver substantial value and life-saving treatments to vulnerable patient populations where simple infections can pose serious threats. I am eager to contribute to these efforts together with the AiCuris team and to expedite the path toward product approval, ensuring that critical medical needs are met and that vulnerable patients receive the care they urgently require,” added Cynthia Wat, MD . Cynthia Wat joins AiCuris from her most recent position as a Pharmaceutical Consultant and Director at ID Pharma Consultancy Ltd. With more than 25 years of extensive global drug development experience, she has held leadership and managerial roles for licensed products Fuzeon ® , Pegasys ® , and Tamiflu ® at Roche that included pivotal registration trials and multiple filing activities. As a recognized expert in infectious diseases and hepatitis, Dr. Wat has a proven track record for creating and successfully implementing novel clinical trial designs and clinical development strategies for chronic Hepatitis B, COVID-19, and other respiratory viruses and is experienced in a broad range of modalities, small molecules, biologics, RNA therapeutics including antisense oligonucleotides and predictive biomarker research. Additionally, she is a strong collaborator with health authorities, and has provided recommendations to NICE and other regulators in her role at the Faculty of Pharmaceutical Medicine. Dr. Wat holds a Bachelor of Medicine, Bachelor of Surgery (MBBS) from St. Mary's Hospital Medical School, Imperial College, London, a Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine (FPM) and is a Member of the Royal College of Physicians (MRCP). About AiCuris AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS ® , marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.