– PRTX007 demonstrated favorable safety profile across all analyzed cohorts, with no serious adverse events (SAEs) observed –
– Well-controlled activation of innate and adaptive immune responses observed without an increase in pro-inflammatory factors –
– Data support the suitability of PRTX007 for investigation as a key component of combination therapy for chronic hepatitis B virus (HBV) infection –
San Diego, November 10, 2023–(BUSINESS WIRE) –Primmune Therapeutics, a biotechnology company harnessing the power of the innate immune system, today announced clinical data from its first-in-human Phase 1 study of PRTX007, an orally administered novel small molecule prodrug. Molecules Toll-like receptor 7 (TLR7)-specific agonists, at the 2023 American Association for the Study of Liver Diseases (AASLD) Annual Meeting (Liver Meeting). The data presented highlight the suitability of PRTX007 as a combination therapy for the treatment of chronic hepatitis B virus (HBV) infection.
This is a first-in-human, Phase 1, single-center, prospective, randomized, double-blind, placebo-controlled study of 9 single-ascending dose (SAD) and 4 multiple-ascending dose (MAD) cohorts of PRTX007 at intervals Orally administered once a day (QOD) to adult healthy volunteers. In addition to the primary objective of assessing the clinical safety and tolerability of PRTX007, the study also aims to evaluate the pharmacokinetics and pharmacodynamics of PRTX007 and PRX034 and to determine pharmacodynamic and immunological potential for future infectious viruses. Specific active dose ranges for disease studies. mark.
The data showed that PRTX007 demonstrated a good safety profile in all analyzed cohorts, with no serious adverse events (SAEs) observed. QOD dosing was shown to activate innate and adaptive immune responses, with significant increases in CD8+ T cell and NK cell activation observed in all healthy volunteers from pre-treatment to end of dosing. No clinically relevant increases in the expression or circulating levels of proinflammatory cytokines were observed across any dose range studied.
“We are encouraged by the results of this Phase 1 study, which demonstrated the safety and tolerability of PRTX007 in healthy volunteers. These results should translate to patients with acute and chronic viral diseases, including chronic HBV infection. treatment, and supports further exploration of PRTX007’s use in future research into infectious viral diseases,” said James Appleman, Ph.D., co-founder and chief scientific officer of Primmune Therapeutics. “The well-controlled, coordinated activation of innate and adaptive immune responses observed without increasing pro-inflammatory factors suggests that PRTX007 has the potential to become a key component of combination therapies to achieve functional cure of chronic HBV infection.”
title: Clinical validation of an oral, systemically activated TLR7 agonist that enhances host immune responses to chronic viral diseases, including hepatitis B virus
Keynote speaker: Curtis L. Scribner, MD
Poster ID: 1463-C
Demo date and time: Friday, November 10th – 12:00pm – 1:00pm ET
Place: Hynes Convention Center Hall C (Second Floor)
Other highlights from the poster presentation include:
PRTX007 demonstrated a favorable safety profile when administered orally across all 9 SAD and 4 MAD cohorts. Most adverse events were mild and unrelated to dose, and there were no dose adjustments or discontinuations due to treatment-related adverse events throughout the study. The most common drug-related AE was headache, which was seen in both treatment and placebo groups, regardless of dose.
Repeated oral QOD doses of PRTX007 increased the magnitude of the antiviral mRNA response. PRTx007’s short half-life enables targeted short-pulse exposure of active agonists without drug accumulation between doses.
PRTX007 demonstrates that interferon-stimulated gene (ISG) expression is well controlled, dose-independent, without a significant increase in circulating IFN. There was no increase in the expression or circulating levels of proinflammatory cytokines (e.g., TNFα, IL-6, IL-1β).
CD8+ T cell and NK cell activation (CD38+ marker) increased significantly from pre-treatment to end of dosing in all HVs.
PRTX007, Primmune’s lead clinical development candidate, is designed to provide well-tolerated, controllable, long-term stimulation of the innate immune response while enhancing long-lasting and effective innate and adaptive immune responses. PRTX007 administration uniquely activates plasmacytoid dendritic cells (pDCs), leading to a systemic immune poly-IFN response without stimulating the production of NF-κB-driven pro-inflammatory factors such as IL-6, TNFα, or IL-1β. Activated pDCs deliver interferons directly to target cells via paracrine transfer. Conceptually, this amounts to administering a therapeutically effective mixture of all type I/III interferons while avoiding the associated side effects and adverse events. Furthermore, PRTX007 administration resulted in systemic activation of anti-tumor effector CD8+ T cells and NK cells.
About Primmune Therapeutics
Primmune Therapeutics is a clinical-stage biotechnology company harnessing the power of the innate immune system by developing small molecule, oral Toll-like receptor 7 (TLR7) agonists. For more information, please visit https://www.primmunerx.com/.
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