At long last – the Herpes Cure Pipeline 3.0 is (almost) ready for release. To confirm your attendance, please join the wait list for the Pipeline Release Party.
The Herpes Cure Pipeline is the global resource for clinical research in cure and treatment for Herpes Simplex. Herpes Cure Advocacy monitors the clinical pipeline globally – including only preclinical studies that have expressed intent of commercialization.
The Pipeline Release Party will have special guests from the Herpes Cure Advocacy medical advisory board, scientists, and advocates!
Are you or your colleagues involved in clinical research for herpes cure or treatment? Have other additions to the Herpes Pipeline 2.0? To drop us a pipeline tip, click here.
Advocates Town Hall Meeting: Herpes advocates town hall meetings are open to patients, professionals, and those looking to get involved to make a difference. We’ll discuss Herpes Cure Advocacy urgent priorities, a 90 day action plan for new advocates, and ways to get more involved. Please submit questions in advance at info@herpescureadvocacy.com.
Innovative Molecules advances IM-250: The clinical trial center in Heidelberg, Germany has Phase 2 clinical trials are scheduled for 2024. The clinical phase 1 study investigates the safety, tolerability, and pharmacokinetics of a medication in development (IM-250) against infections with herpes simplex viruses in healthy test subjects. Participants: Healthy men and non-pregnant women aged 18-50 years.
BDGene Therapeutics is a Chinese biotech company based in Shanghai. BDgene now has approval to run Phase 3 trials (held in China) on their gene therapy cure for HSV-1 keratitis.
The gene editing treatment for viral keratitis (BD111), developed based on BDmRNA delivery patent technology, has completed 3 human clinical trials of IIT. It is the only technology of Cas9 mRNA delivery by lentivirus in the world, and also the second human clinical research project of CRISPR-Cas9 gene editing treatment in human body in the world. BDgene are currently advancing pre-clinical research in gene therapy for HSV-2.
BD111 was previously approved as an orphan drug by the US FDA in June 2022. BDGene representatives have now entered pre-IND meetings with the FDA and are in final submission stages. This implies to me that they will start trials in the US in the near future.
After IND approval, BDgene will start Phase 3 clinical trials in three Chinese hospitals.
Herpes Cure Advocacy celebrates a step forward on the path to the cure, treatment and prevention of Herpes. NIH has assembled a Multi-Council Working Group for Herpes Simplex Virus and are calling for input from field scientists and the general public. Herpes patients and field experts are excited to see this progress, an important win for advocates, who have been urgently calling on the federal government for a response. There is new momentum in the field of herpes, a common and important infectious disease area that has been stagnant for decades. There is currently an addendum for the cure treatment and prevention of Herpes being developed and incorporated into the 2020 National STI Strategic Plan at OASH. Additionally NIAID/CDC held a joint workshop for genital herpes in November 2022, the first federal meeting for Herpes in decades.
The new trans-NIH Herpes Simplex Virus (HSV) Working Group is engaged in the development of a strategic research plan on Herpes Simplex Virus. The working group is being led by the National Institute of Allergy and Infectious Diseases and includes representatives from the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, the National Institute on Minority Health and Health Disparities, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The strategic research plan will be structured around four areas of research noted below. Working group leaders have also issued a request for information into the research plan from field experts and the general public.
Priority 1:Improve fundamental knowledge of HSV biology, pathogenesis, and epidemiology
Enhance fundamental knowledge of HSV biology, including but not limited to: viral interactions with host cells and mechanisms of replication and transport; fundamental aspects of innate and adaptive immune response to HSV; HSV disease pathogenesis in multiple organ systems, including the skin, reproductive tract, eye, and the peripheral and central nervous systems; and the key drivers of disease transmission.
Characterize host and pathogen drivers that underlie dynamics of HSV latency and reactivation
Improve understanding of diverse pathophysiology of HSV infection including neonatal infection and the role of mucosal immunity to reduce genital and orolabial infection and disease; and a deeper understanding of the neurologic impact of HSV infection, including herpes simplex encephalitis, post-herpetic neuropathic pain, post-herpetic autoimmune encephalitis (i.e., post-HSV NMDARE), and potential associations with neurodegenerative disorders such as Alzheimer’s disease.
Explore epidemiology of and co-morbidities associated with HSV infection
Improve and develop new in vitro and in vivo models that reflect human disease
Priority 2:Accelerate research to improve diagnosis
Develop improved biomarkers and technologies for herpes diagnosis
Improve sensitivity and specificity of serologic tests that can be made commercially
Support research to improve point-of-care diagnostics
Priority 3:Improve strategies treat and cure HSV
Identify candidates for elimination of virus or functional cure
Advance the development of novel treatment strategies, including strategies for preventing HSV entry into the central nervous system and for reducing sequelae of HSV encephalitis.
Evaluate the safety and efficacy of treatment strategies in diverse populations and age groups
Optimize therapy to reduce shedding and transmission
Priority 4:Advance research to prevent HSV infection
NIH Request for Information
On April 21, a notice with a Request for Information (RFI) was shared, inviting comments and suggestions on National Institutes of Health’s (NIH) key strategic approaches to develop a Herpes Simplex Virus Strategic Plan.
This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework. Learn more and respond to the RFI here.
HHS Listening Sessions: Two listening sessions were held this past week in an effort to gather insights for an addendum to the HHS 2020 STI Strategic Plan. Both patients and providers spoke with OIDP, NIH, and CDC stakeholders about their experiences and ideas for how to help cure, treat and prevent herpes in America. HCA is supporting our federal partners in this effort. There will be future opportunities for input including a listening session at the STD Engage conference in New Orleans May 16-18.
Fundraising continues with industry partners, foundations, and individuals. Want more updates? Want to change the field faster? Please donate what you can to help advance this work!
Corporate and industry partners interested in sponsoring our work? Want to host a patient workshop or speak on Meet the Experts? Email us at info@herpescureadvocacy.com for sponsorship opportunities.
Dr. Harvey Friedman has joined the Herpes Cure Advocacy Medical Advisory Board.
NEXT UP on Meet the Experts Series: April 26th 6pm EST Terri Warren from Westover Clinic. Register now!
Dr. Gerald Kleymann presented an update on the HSV helicase-primase inhibitor IM-250, with potent in-vitro and in-vivo activity against HSV including nucleoside-resistant mutants due to its different mechanism of action. Clinical Trials are planned soon.
Mark your calendars! The HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) wants to hear from members of the STI community during two virtual listening sessions on April 4th and April 6th, 2023.
OIDP is developing an addendum to the STI National Strategic Plan to include herpes simplex virus (HSV) types 1 and 2 in the United States. The STI Plan provides a roadmap toward a nation where STIs are prevented and where every person has high-quality STI prevention, care, and treatment while living free from stigma and discrimination. To help inform the HSV addendum to the STI Plan, OIDP will host two separate listening sessions for provider and community audiences. These listening sessions are geared for US residents only.
Providers Session:
Tuesday, April 4, 2023, from 3:00pm-4:30pm (EST)
National, state, local, and tribal health departments and organizations
Positive news abounds for the Aicuris team, and patients living with HSV, with the release of new results from their Phase three clinical trials for Pritelivir and initiation of a new clinical trial studying the use of Pritelivir in healthy patients.
Pritelivir was found to be safe and well tolerated up to 600 mg following single and up to 200 mg following multiple once-daily doses. Considering a therapeutic dose of 100 mg once-daily, Pritelivir demonstrated a favorable safety and tolerability and pharmacokinetic profile in healthy subjects to support further development.
In exciting, if long-awaited news for patients globally, AiCuris has also initiated a new clinical study that has commenced testing Pritelivir in healthy, immune competent patients. AiCuris had previously been studying Pritelivir among immunocompromised for several years and are currently in Phase three. It is widely assumed it’ll be approved for immunocompromised soon, potentially in 2024, and the FDA has already granted breakthrough designation streamlining the process for approval.
Clinical Trial for new Herpes Simplex Virus Treatment
With the positive results from the initial safety studies in the immunocompromised – this trial would likely be the start of a move to bring the to the general population. Read more and apply to participate (note the study location in London, England) here: Pritelivir Study In Healthy Individuals. The new clinical trial for Pritelivir in health patients ends in May 2023 (five months of study) so AiCuris is moving quickly on Phase one – likely with recent learnings from the earlier trial.
The Centers for Disease Control and Prevention (CDC), the Office of Science (OS) in late December 2022 issued a Broad Agency Announcement (BAA) for the competitive selection of research proposals, including a Request for Proposal (RFP) for a new serologic test for herpes simplex virus (HSV).
Therefore, the goal of the RFP is to develop, validate, and make accessible confirmatory (2nd step) HSV serologic assays for diagnosis, especially for HSV-2, to improve the specificity of the testing algorithm. Offering such testing widely will increase equitable access for all persons in need of confirmatory testing.
Because of poor performance of commercially available FDA-approved tests, and limited availability of confirmatory (2nd step) testing, prevention efforts for transmission of herpes have been insufficient. Herpes spreads without public health intervention primarily by asymptomatic carriers, emphasizing the critical and unmet need for accurate diagnosis and testing. With this announcement, the CDC indicates their support for accurate testing and diagnosis, and further advances the prevention of HSV transmission as a national priority.
Learn more about advocacy for herpes cure, treatment and prevention here.
Sexual health advocates have long called on the CDC, FDA and federal agencies to address the silent epidemic of herpes by urgently prioritizing cure, treatment and prevention. Providers and patients have been asked to report the poorly performing tests to the FDA. There are 572,000 confirmed cases of genital herpes a year in the US, according to a 2018 report. Prevalence of oral herpes is unknown but estimated to be 50% of Americans.
Project objectives include:
CDC seeks projects to develop type-specific serologic assays for confirmation of HSV diagnosis, especially for HSV-2, that improves the specificity of the serology testing algorithm overall.
Develop technology and user interface for specimen submission with high accessibility to various healthcare providers and linkage to commercial submitter laboratories for processing and reporting.
Learn more about the CDC request for proposals and apply here.
Hyundai Biosciences have applied for a clinical study in Korea to test the efficacy of CP-COVO3, a new candidate treatment for viral infections, on HPV.
This antiviral agent, developed in Korea, has an innovative ‘viral removal’ mechanism applicable to all viruses, unlike existing antiviral agents that target only specific viruses. It is expected to open a new chapter in the world’s antiviral drug history if it produces valid clinical results.
This new clinical trial is not for HSV specifically, but its mechanism of action should apply to HSV as well if it works for other pathogens. Niclosamide, the active ingredient in CP-COV03, has been proven to treat HSV in infected cells (clinical data is pending publication) via a novel delivery mechanism. Niclosamide has been used as a medication for various diseases for over 60 years and has a strong safety profile.
Hyundai Biosciences previously has successfully completed phase II clinical trials for treating COVID and monkeypox, and applied for fast-track approval and distribution in May 2022. They have also started setting up manufacturing sites in the U.S. They’re now starting studies on other diseases.
The research team has said, “Niclosamide is a substance that has already been taken as an insect repellent for more than 60 years, and its safety has been sufficiently verified. As it has an effective antiviral function, I thought that it has sufficient potential for HPV treatment for which antiviral drugs have not yet been developed.”
