Pritelivir, a proprietary Phase 3 product candidate with U.S. FDA breakthrough designation
Pritelivir is an innovative therapeutic candidate, currently being evaluated in a pivotal Phase 3 trial for the treatment of acyclovir-resistant herpes simplex virus (HSV) infections in immunocompromised patients (Read more). Immunocompetent individuals experience, recurrent labial and genital herpes infections. In immunocompromised patients, symptoms are more severe and include disseminated disease, keratitis and encephalitis. Pritelivir inhibits replication of both(HSV-1 and HSV-2). In clinical trials, pritelivir showed favorable tolerability and pharmacologic properties and retained activity against viruses resistant to marketed drugs. Based on these results, pritelivir was granted breakthrough therapy designation by the US FDA.
RNA-based therapy to prevent BK virus reactivation in kidney transplant patients to enter the clinic in 2024
AIC468, is a program to prevent BKV infections and re-activation in patients with transplanted kidneys. BKV-positive patients might develop BKV-associated nephropathy and lose their transplant. With no approved antiviral drugs, current standard of care is to reduce immunosuppression therapy, which in turn increases the likelihood of graft rejection and loss. AIC468 is an antisense oligonucleotide designed to target viral replication within infected cells, thus overcoming limitations of other approaches in development. AIC468 has demonstrated favorable pharmacokinetics and significant inhibition of BKV replication. A first in human trial is planned for 2024.
Developing innovative treatments for adenovirus infections with focus on ocular infections
Additional preclinical programs are designed to combat human adenovirus (ADV) infections, including systemic infections in pediatric transplant patients and ocular infections, specifically highly contagious epidemic keratoconjunctivitis (EKC). EKC is one of the most common causes of acute conjunctivitis, with characteristic clinical features such as sudden onset of acute follicular conjunctivitis, with watery discharge, hyperemia, chemosis, and ipsilateral preauricular lymphadenopathy. Despite the high incidence and severity of ADV eye infections, there are currently no approved treatments addressing the root cause of these conditions. In response to this unmet medical need, we are advancing several programs.
Transforming transplantation medicine with an innovative antiviral solution
PREVYMIS®, licensed to MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (NYSE: MRK)), is a first-in-class antiviral agent that was approved by the FDA in 2017. It is commercialized for the prophylaxis of cytomegalovirus (CMV) infections in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants (HSCT) or kidney transplants. PREVYMIS® is marketed in this indication in over 60 countries outside the US, including in the EU, Canada, Japan and China, with increasing annual revenues. Recently, the FDA expanded its approval to include the prophylaxis of CMV disease in donor CMV-seropositive/recipient CMV-seronegative kidney transplant patients. Furthermore, PREVYMIS® has received approval in Japan for use in patients receiving solid organ transplants, broadening its global impact for people with transplants.