News Release March 10, 2025

Adovate Awarded $800,000 by Virginia Catalyst for Phase 2 Clinical Trial of ADO-5030 for the Treatment of C. Difficile Infections

 

This is the second Virginia Catalyst award to develop Adovate’s breakthrough therapies.

 

Charlottesville, VA – March 10, 2025 – Adovate, LLC (“Adovate” or the “Company”), a pharmaceutical company developing drug candidates targeting the adenosine receptors, today announced its receipt of a grant award of $800,000 from Virginia Catalyst, which specializes in developing and leading strategic initiatives in areas where Virginia can be a national and global leader. This prestigious award is to advance development of Adovate’s lead drug candidate, ADO-5030, as a treatment for Clostridioides difficile (C. diff or C. difficile) infection (“CDI”) into Phase 2 clinical testing.

 

Under this grant, Adovate will collaborate with the University of Virginia and Virginia Tech to test ADO-5030 in human patients with CDI. ADO-5030 is a new generation adenosine 2B receptor (“A2BR”), and is expected to address the significant unmet medical needs of patients suffering from recurrent CDI. ADO-5030 is designed as a therapeutic option that goes beyond traditional antibiotic treatments by targeting both CDI toxin-induced inflammation and microbiome restoration.

 

Under the scientific leadership of Adovate’s Chief Scientific Officer Dr. Joel Linden, Dr. Cirle Warren at the University of Virginia, and, Dr. Liwu Li at Virginia Tech, the project is focused on developing a novel therapeutic that could serve as a vital treatment option for this often deadly disease.

 

“We are honored to receive this award from the Virginia Catalyst,” stated William Stilley, Chief Executive Officer at Adovate, LLC. “Adovate’s mission to develop novel, patentable, next generation molecules targeting specific adenosine receptors, promises to create significant advancements in treatments for C. diff, as well as asthma and other diseases. The Virginia Catalyst grant to Adovate will play a crucial role in our efforts to bring our innovative drug candidate, ADO-5030, to the patients who need it most.”

 

“CDI remains a significant and growing public health challenge, particularly for immunocompromised and elderly patients who face a high risk of recurrence and severe outcomes,” stated Dr. Cirle Warren, Research Professor of Medicine, Infectious Diseases and International Health at the University of Virginia. “Current antibiotic treatments, while effective in the short term, do not address the underlying disruptions to the gut microbiome, often leading to reinfection, increased patient burden and sometimes death. Novel approaches that restore microbial balance and target the inflammatory response have the potential to transform the treatment landscape for C. diff, reducing recurrence rates and improving patient outcomes. Based on in vivo evidence to date, ADO-5030 has demonstrated a strong ability to reduce C. diff toxin-induced inflammation and enhance gut tissue recovery, suggesting it could provide a more effective and durable solution for patients suffering from recurrent C. diff infections.”

 

About C. difficile (C. diff)

 

Clostridioides difficile (C. diff or C. difficile) infection (CDI) is the leading cause of antibiotic- and healthcare-associated infectious colitis in the United States according to the New England Journal of Medicine. CDI affects approximately 500,000 patients annually in the U.S., resulting in nearly 30,000 deaths (CDC 2023). The Centers for Disease Control and Prevention classified CDI as an antimicrobial-resistant pathogen and an “urgent” public health threat due to its increasing prevalence and the rising incidence of recurrent infections. The economic burden of CDI is substantial, with inpatient costs exceeding $1 billion annually, and recurrent CDI cases generating direct medical costs ranging from $68,000 to $83,000 per patient per year in 2023.

CDI is characterized by severe intestinal inflammation caused by C. diff proliferation and toxin release in the setting of antibiotic-depleted gut microbiota. Up to 25% of patients experience recurrence after an initial infection, and the risk increases to 60% in those with prior infections. The majority of recurrences and fatalities occur in immunocompromised and elderly patients, highlighting the significant clinical, social, and economic impact of CDI.

 

Despite the high burden of disease, the current standard of care remains broad-spectrum antibiotics, which fail to restore a healthy gut microbiome and often lead to recurrent infections.

 

About Adovate, LLC

 

Adovate is a biopharmaceutical company focused on inventing and developing best-in-class drug candidates targeting the adenosine receptors. Additional information is available at www.adovate.com.

 

Forward Looking Statements

 

This communication contains certain “forward-looking statements” within the meaning of applicable securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding  ADO-5030 addressing the significant unmet medical needs of patients suffering from recurrent Clostridioides difficile (C. diff or C. difficile), the collaboration with UVA and Virginia Tech addressing the significant unmet medical needs of patients suffering from recurrent C. diff, ADO-5030 becoming a therapeutic option that goes beyond traditional antibiotic treatments or becoming a vital treatment option for the underserved patient population suffering from C. diff, and ADO-5030 reducing C. diff toxin-induced inflammation and enhance gut tissue recovery. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, Adovate’s ability to develop novel, patentable, next generation molecules targeting specific adenosine receptors which will create significant advancements in treatments for C. diff and other diseases, the Virginia Catalyst grant playing a crucial role in Adovate’s efforts to bring ADO-5030 to patients who need it most,, Adovate’s mission to develop novel, patentable, next generation molecules targeting specific adenosine receptors resulting in significant advancements in treatments for C. diff, as well as asthma and other diseases, and Adovate inventing and developing best-in-class drug candidates targeting adenosine receptors. These risks should not be construed as exhaustive. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

 

 

FOR MORE INFORMATION, PLEASE CONTACT:

 

Investor Relations:

ir@adovate.com

 

Media Relations:

media@adovate.com