PARIS, Dec. 18, 2025 /PRNewswire/ — Peptinov today announced the publication of the Phase 1 clinical results for PPV-06, its first-in-class active immunotherapy targeting IL-6, in the peer-reviewed journal Nature Communications. The randomized, double-blind, placebo-controlled study was conducted in 24 patients with inflammatory knee osteoarthritis under the supervision of Prof. François Rannou at Cochin Hospital (AP-HP, Paris).

The study met its primary objective. PPV-06 demonstrated an excellent safety and tolerability profile, with no serious adverse events and no dose-limiting toxicities. Reported adverse events were mostly mild, transient injection-site reactions, occurring at similar frequencies to placebo — a strong indicator of clinical tolerability for a first-in-human immunotherapy.

All PPV-06–treated participants developed anti-IL-6 antibodies with measurable neutralizing capacity, confirming the robust immunogenicity of this active immunization strategy. While not designed to assess efficacy, the trial showed encouraging trends in KOOS functional scores, with the strongest improvements observed in participants exhibiting higher IL-6 neutralization. These aligned clinical and biological signals further support IL-6 modulation as a meaningful mechanism in chronic low-grade inflammation.

Prof. François Rannou commented:

“We conducted this study with rigorous clinical oversight and a strong focus on patient safety. The results show that PPV-06 is well tolerated and support the scientific relevance of this innovative active-immunotherapy approach targeting IL-6. For patients facing a lack of durable therapeutic options in osteoarthritis, these findings represent an encouraging first step toward clinical translation.”

As the first active immunotherapy designed to modulate IL-6, PPV-06 has the potential to offer a differentiated therapeutic alternative for patients with inflammatory and age-associated chronic diseases. Demonstrating a controlled immune response against IL-6 in humans represents a significant milestone for this novel therapeutic modality.

Building on these results, Peptinov is preparing a broad Phase 2 clinical program planned for 2026, targeting inflammatory knee osteoarthritis, endometriosis, and rare inflammatory relapse-prone diseases such as giant cell arteritis and Behçet’s disease.

René Azoulai, CEO of Peptinov, added:

“Publication in Nature Communications is an important milestone for Peptinov. These Phase 1 results reinforce our conviction that active immunotherapy targeting excess self-proteins could define a new class of treatment for chronic inflammatory diseases and reach a wide patient population.”

Publication:
www.nature.com/articles/s41467-025-64710-6

About Peptinov:
For more information, visit www.peptinov.fr

Contact: [email protected]

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