AiCuris Announces Key Achievements Validating Anti-viral Pipeline for Immunocompromised Patients

AiCuris Anti-infective Cures AG, based in Wuppertal, Germany, has announced several significant accomplishments related to its antiviral therapeutic programs. These milestones include developments for letermovir (commercialized by MSD under the brand name PREVYMIS®), along with advancements in their broader pipeline targeting infections particularly affecting individuals with compromised immune systems.

CEO Larry Edwards highlighted the company's commitment to providing therapeutic options for immunocompromised individuals, emphasizing the importance of these treatments in preventing potentially fatal infections. The recent approval of PREVYMIS® in Japan is a testament to its efficacy in various transplant settings where CMV infections pose severe risks. This approval, combined with existing authorizations in the U.S. and Europe, underscores the effectiveness of AiCuris' drug development capabilities. AiCuris is also striving to achieve similar success with its other pipeline candidates, such as pritelivir, which is on the verge of Phase 3 results, and AIC468, which is approaching its first human trials.

PREVYMIS® recently received approval in Japan for use in adult patients undergoing solid organ transplants. This marks the first pan-transplant indication for PREVYMIS®, an antiviral agent developed by AiCuris and marketed by MSD. It is used to prevent cytomegalovirus (CMV) infections and diseases in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants, as well as in adult kidney transplant recipients at high risk. Following this approval, AiCuris will receive a milestone payment of €7.5 million from MSD. PREVYMIS® is now available in over 60 countries.

AiCuris has also made strides with its lead candidate pritelivir (AIC316), an innovative therapeutic targeting HSV replication. Pritelivir is in Phase 3 trials for treating acyclovir-resistant HSV infections in immunocompromised patients, with patient enrollment expected to conclude in the first half of 2025. Recent pharmacokinetic data published in the journal Clinical Pharmacology in Drug Development indicate a low risk of drug-drug interactions with pritelivir, an important factor for its safety and efficacy.

Another promising candidate from AiCuris' pipeline, AIC468, is gearing up for clinical trials following regulatory approval from German authorities. AIC468 is an antisense RNA therapeutic designed to combat BK virus (BKV) infections, which can lead to nephropathy and increase the risk of chronic kidney failure or graft loss. The Phase 1 trial for AIC468 is set to start in the third quarter of 2024, with up to 88 healthy volunteers participating. Preclinical studies have shown that AIC468 effectively inhibits BKV replication, offering a potentially groundbreaking treatment for patients at risk.

Larry Edwards expressed optimism about the potential of pritelivir and AIC468 to revolutionize antiviral therapies for immunocompromised individuals. He noted the publication of pritelivir's pharmacokinetic data as a significant achievement and emphasized the importance of the upcoming Phase 1 trial for AIC468 in addressing BK virus infections.

PREVYMIS® (letermovir), developed by AiCuris and marketed by MSD, is indicated for prophylaxis of CMV infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants and adult kidney transplant recipients at high risk. It is marketed in over 60 countries and has recently been approved in Japan for preventing CMV infections in adult solid organ transplant recipients.

Pritelivir, developed by AiCuris, is a novel helicase-primase inhibitor targeting HSV-1 and HSV-2. It offers a unique mechanism of action by inhibiting viral DNA synthesis differently from traditional antivirals. Recognized with Breakthrough Therapy designation by the FDA, pritelivir is advancing through a pivotal Phase 3 trial.

AIC468 is an innovative RNA-based therapy aimed at treating BK virus reactivation in kidney transplant patients. It targets viral replication by inhibiting the splicing of mRNA coding for the BKV master regulator large T-antigen, showing promising preclinical results.

AiCuris continues to address the needs of immunocompromised individuals with its robust pipeline and expertise in antiviral therapies, aiming to provide effective treatment options for those at risk of severe infections.