The proprietary clinical program IPVU2025 is targeting a rare disease indication of severe neuropathic pain, vulvodynia. IPVU2025 is based on Initiator’s Pudafensine (IP2015) API, which has already been proven safe and tolerable in clinical trials and has demonstrated efficacy for erectile dysfunction. In preclinical studies, pudafensine is effective and markedly inhibits neuropathic pain.
Clinical status
Positive results from a Proof-of-Principle pain model study were reported in September 2022.
The Phase I study was a randomized, double‑blind, placebo‑controlled study in 24 healthy male subjects, investigating the effects on pain measures (hyperalgesia, allodynia, and subjects’ pain ratings) of single doses of pudafensine, pregabalin as an active control, and placebo. The pain was induced by intradermal capsaicin. Pudafensine demonstrated a statistically significant effect on allodynia (p=0.049) and showed a dose-dependent effect on the measured pain parameters. Pregabalin (p=0.083) and IP2015 (p=0.051) tended to reduce hyperalgesia, although the effects on hyperalgesia were not statistically significant compared to placebo-treated subjects.
In the assessment of subjective pain ratings, the mean values for pudafensine showed 2- and 5-fold higher effects compared to pregabalin and placebo, respectively. In support of these positive results, pudafensine demonstrated data in the Quantitative Sensory Test pain assessments related to pain in line with the primary pain assessments provided above. In the heat detection and thermal sensory (warm) threshold tests, respectively, statistically significant outcomes were detected for pudafensine when tested within test subjects. There were no observations of unexpected adverse events, and pudafensine demonstrated a superior safety profile as compared to pregabalin.
The study was conducted in collaboration with the MAC clinic, Manchester, UK.
Vulvodynia Clinical Proof-of-Concept (cPoC) study:
The cPoC Phase 2a study is a randomized, placebo-controlled, four-way crossover clinical trial in 24 women with vulvodynia, to evaluate the pain-relieving effects and safety of single oral doses of pudafensine. The study will be conducted with the MAC Clinical Research Unit in the UK, targeting a start in H2 2025.