AiCuris Announces Milestone Achievements Further Validating its Pipeline of Anti-viral Solutions for Immunocompromised Patients
2024年7月17日 - 6:00PM
ビジネスワイヤ(英語)
- PREVYMIS® (letermovir) gains approval in Japan for prevention
of cytomegalovirus disease in adult patients with a solid organ
transplant (SOT) triggering next milestone payment of EUR €7.5
million from partner MSD
- Comprehensive pharmacokinetic data package for Phase 3 lead
candidate pritelivir published in Clinical Pharmacology in Drug
Development
- Company receives clinical trial approval to initiate Phase 1
study with AIC468 in healthy volunteers; AIC468 is designed to
treat BKV-associated nephropathy and graft loss in kidney
transplant patients
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.
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Trophic Communications Dr. Stephanie May and Dr.
Charlotte Spitz Phone: +49 1713512733 Email: aicuris@trophic.eu