Acyclovir

WUPPERTAL, Germany--( BUSINESS WIRE )-- AiCuris Anti-infective Cures AG , announced today multiple milestone achievements for letermovir (marketed by MSD as PREVYMIS ® ) and across its pipeline of anti-viral therapeutics serving the growing population of people whose immune systems are impacted due to disease or immunosuppressive therapies. These achievements recognize AiCuris’ rapid progress in developing a clinical pipeline of precise therapies to effectively treat infections in a population for whom an otherwise manageable infection, can mean life or death. “Our mission is to make a difference for people with weakened immune systems, by giving them options in preventing or treating infections that are life-threatening for them. The expanded approval of PREVYMIS ® in Japan highlights its unique drug profile in diverse transplant settings where CMV infections pose a significant risk to adult patients on immunosuppressive therapies. Combined with the existing approvals in the U.S. and Europe, it provides further validation for the outstanding drug development capabilities of the AiCuris team and the benefit PREVYMIS ® can provide for immunocompromised patients,” said Larry Edwards, CEO of AiCuris. “It is our goal to achieve the same level of success for patients with our two follow-on pipeline programs pritelivir, which is close to pivotal Phase 3 read-out, and AIC468’s first-in-human study starting in the near-term.” PREVYMIS ® Update In May, PREVYMIS ® (letermovir) achieved approval in Japan for the use in adult patients receiving solid organ transplants (SOT). This significant milestone represents the first pan transplant indication approval for PREVYMIS ® , a first-in-class antiviral agent commercialized by our partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant and prophylaxis of CMV in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). PREVYMIS ® is marketed in over 60 countries. Following this achievement, AiCuris will receive a milestone payment of EUR €7.5 million from MSD. Pipeline Updates AiCuris published pharmacokinetic data for its lead candidate pritelivir (AIC316), an innovative therapeutic candidate targeting HSV replication, in May 2024. Pritelivir is currently being evaluated in a Phase 3 trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. The study expects to complete patient enrollment in 1H 2025. The study titled “ Evaluation of the Clinical Drug-Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach ” was recently published in the journal Clinical Pharmacology in Drug Development and provides data on the drug-drug interaction profile of pritelivir. The results demonstrated that pritelivir has a low risk of drug-drug interaction, as there was no effect on intestinal uptake and efflux transporters. These findings are crucial for ensuring the safety and efficacy of pritelivir as a treatment option for patients with resistant HSV infections, who are often receiving a range of additional treatments. In addition, AiCuris’ third pipeline candidate AIC468 is rapidly nearing the clinic after the regulatory approval of its clinical trial application by the German national authority. AIC468, an antisense RNA therapeutic candidate, is designed to treat BK virus (BKV) infection, which can lead to BKV-associated nephropathy, increasing the risk of chronic kidney failure or graft loss. AIC468 will be investigated in a first-in-human Phase 1 trial in healthy volunteers starting in Q3 of 2024. Up to 88 healthy individuals are expected to be enrolled in multiple single and multi-ascending dose cohorts with the objective to investigate safety and tolerability of AIC468. AIC468 specifically inhibits BKV replication, addressing the critical need to target the virus directly. By not compromising ongoing immunosuppressive treatments - the current standard of care – it helps to reduce the risk of graft loss. Preclinical studies have shown AIC468's mechanism of action effectively inhibits BKV replication in human kidney cells and achieved efficacious concentrations in kidney tissues in vivo . Additionally, a favorable pharmacokinetic and safety profile as well as a broad therapeutic window could be demonstrated preclinically warranting the start of clinical development. “AiCuris is driving innovation in antiviral therapies with our pipeline candidates pritelivir and AIC468. The recent publication on pritelivir underscores its potential as a breakthrough treatment for acyclovir-resistant HSV infections for immunocompromised patients,” said Larry Edwards . “Additionally, achieving Phase 1 approval for AIC468 marks a significant milestone in our efforts to address BK virus infections, showcasing promising preclinical efficacy data. We look forward to the upcoming data from these programs which will be important steppingstones in developing novel therapies for immunocompromised people.” About Prevymis ® PREVYMIS ® (letermovir), developed by AiCuris and marketed by MSD, is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant and prophylaxis of CMV in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]. The drug is marketed in more than 60 countries outside the U.S., including in the E.U., Canada, Japan and China, and has received approval for prevention of CMV infections in adult solid organ transplant (SOT) recipients in Japan in 2024. The recent approval for SOT in Japan is supported by robust clinical trials demonstrating its efficacy and safety in preventing CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative). About Pritelivir Pritelivir, a novel helicase-primase inhibitor developed by AiCuris, targets both HSV-1 and HSV-2. These viruses are responsible for genital, oral or disseminated infections with increasing severity and resistance development in immunocompromised people. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, a mechanism distinct from nucleoside analogues like acyclovir. Earlier Phase 1 and Phase 2 trials in immune competent and immune compromised individuals showed a favorable safety profile and an improved clinical efficacy compared with standard of care treatments like valaciclovir and Foscarnet (including resistant or intolerant infections). Recognized with Breakthrough Therapy designation by the FDA for immunocompromised patients, pritelivir is currently advancing through a pivotal Phase 3 trial. The results of this trial will serve as a basis for filing for marketing authorization in 2026. About AIC468 AIC468 is a pioneering RNA-based therapy designed to treat BK virus (BKV) reactivation in kidney transplant patients. BKV infections prove to be a significant clinical challenge, particularly for kidney transplant recipients, as they can lead to BKV-associated nephropathy, resulting in chronic kidney failure or graft loss. To date, there are no approved antiviral treatments for BKV; the only option is to reduce immunosuppression therapy, increasing the risk of graft rejection. AIC468 is an antisense oligonucleotide that targets viral replication within infected cells by inhibiting the splicing of mRNA coding for the BKV master regulator large T-antigen. This innovative approach has demonstrated favorable pharmacokinetics and significant inhibition of BKV replication in preclinical studies. AiCuris expects to initiate the first human trial for AIC468 in Q3 of 2024, aiming to provide a much-needed therapeutic option for kidney transplant patients at risk of BKV reactivation. About Herpes Simplex Virus Herpes Simplex Virus (HSV) includes two types, HSV-1 and HSV-2, both of which cause lifelong infections. HSV-1 typically leads to oral herpes, resulting in cold sores around the mouth, while HSV-2 is commonly associated with genital herpes. These viruses can cause recurrent painful blisters and sores, and in severe cases, complications such as encephalitis, disseminated disease and neonatal herpes. HSV infections are widespread globally, with a significant impact on public health, especially immunocompromised patients, due to their high prevalence, more severe and more frequent manifestations and increased potential for drug resistance. About BK Virus BK virus (BKV) is a polyomavirus that commonly infects the urinary tract. While it remains latent in most healthy individuals, it can reactivate in immunocompromised patients, such as those undergoing organ transplantation. Reactivation of BKV can lead to serious complications, including BK virus-associated nephropathy (BKVN), which can cause kidney dysfunction and graft loss in transplant recipients. Managing BKV infections is essential in immunocompromised patients to prevent significant morbidity and improve transplant outcomes. 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.

– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented – – Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials – – Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 – SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced new preclinical data from its investigational herpes simplex virus (HSV) portfolio featured in three presentations at the International Herpesvirus Workshop (IHW), taking place July 13-17, 2024, in Portland, Ore. “We are excited to present promising data from our HSV helicase-primase inhibitor candidates ABI-5366 and ABI-1179, which we are rapidly progressing to deliver on our mission of offering new, effective treatments for people living with chronic viral diseases,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “Current treatments for recurrent genital herpes often fall short in fully managing symptoms and preventing recurrences, and we are pleased with the potential of our HSV candidates to provide a different approach, as highlighted in the data presented at IHW. We continue to advance these candidates and look forward to sharing further updates with the herpesvirus community, including interim ABI-5366 Phase 1a first-in-human data expected in the third quarter of this year.” Approximately 50% of individuals with initial symptomatic genital herpes infection have three or more recurrences per year, including over four million people in the United States and France, Germany, Italy and Spain (collectively, the EU4), and the United Kingdom. While genital herpes can be caused by either HSV type 1 (HSV-1) or HSV type 2 (HSV-2), recurrences are more likely to be experienced by individuals infected by HSV-2. The current standard of care for recurrent genital herpes are nucleoside analogs; however, these are only partially effective in preventing recurrences. Assembly Bio’s HSV antiviral candidates target the HSV helicase-primase complex, an essential HSV enzyme complex with no host equivalent, and are designed for long-acting administration. A poster entitled “The Helicase-Primase Inhibitor ABI-5366 Is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital Herpes” highlights preclinical data that supported ABI-5366’s entry into Phase 1 clinical evaluation. Results demonstrated that ABI-5366 showed low nanomolar activity against both HSV-1 and HSV-2, including broad activity against HSV clinical isolates, and specificity for HSV. ABI-5366 was shown to be generally non-toxic across a variety of cell types with no off-target effects observed in vitro or in vivo, including no activity against carbonic anhydrase esterases. Further, a favorable in vivo safety profile of ABI-5366 was observed in 28-day oral toxicity studies in two species, and pharmacokinetic (PK) studies evaluating ABI-5366 when administered orally or intramuscularly demonstrated long-acting potential for this compound. The Phase 1a/b study for ABI-5366 was initiated in May 2024 and is currently enrolling; interim Phase 1a data are expected in Q3 2024 and interim Phase 1b data are expected in the first half of 2025. Additionally, an oral and poster presentation entitled “Preclinical Characterization of ABI-1179, a Potent Helicase Primase Inhibitor for the Treatment of Recurrent Genital Herpes” features preclinical data from ABI-1179, a structurally distinct, long-acting helicase-primase inhibitor candidate, licensed from Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-1179 has demonstrated low nanomolar activity across HSV-1 and HSV-2 lab strains and clinical isolates, including acyclovir-resistant isolates. In resistance selection studies, ABI-1179 displayed a higher barrier to resistance development than acyclovir. Furthermore, ABI-1179 demonstrated antiviral activity against some HSV-2 strains harboring mutations known to confer resistance to other helicase-primase inhibitors. In a preclinical study, ABI-1179 demonstrated a favorable PK profile that supports the evaluation of once-weekly oral dosing. Further, in a preclinical model of recurrent HSV infection, ABI-1179 significantly reduced the development of recurrent lesions. Assembly Bio expects to initiate a Phase 1a/b first-in-human study of ABI-1179 by the end of 2024. Assembly Bio intends to make the presentations available on the “Events & Presentations” page in the “Investors” section of its website at www.assemblybio.com. The investigational product candidates ABI-5366 and ABI-1179 have not been approved anywhere globally, and their safety and efficacy have not been established. About Assembly Biosciences Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com. Forward-Looking StatementsThe information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsInvestor and Corporate:Shannon RyanSVP, Investor Relations, Corporate Affairs and Alliance Management(415) 738-2992investor_relations@assemblybio.com Media:Sam Brown Inc.Hannah Hurdle(805) 338-4752ASMBMedia@sambrown.com