Initiator Pharma applies to initiate Phase 2a study in vulvodynia
Prenumeration
Beskrivning
| Land | Danmark |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Initiator Pharma A/S, a clinical-stage biotech company, has submitted a clinical trial application (CTA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and local ethics committee in the UK for the approval to conduct a Phase 2a clinical proof-of-concept study in women suffering from vulvodynia, a severe chronic pain condition affecting approximately 10 percent of women worldwide. The study will be conducted together with MAC Clinical Research in the UK.
In May 2025, Initiator Pharma entered a convertible credit agreement with MAC Clinical Research (MAC), in which MAC will take on the cost, up to GBP 2.5 million, for conducting a clinical Phase 2a proof-of-concept study evaluating pudafensine in patients suffering from vulvodynia. The study is expected to start enrolling patients before end of 2025 and is anticipated to conclude by end 2026.
“We are very excited about getting this study initiated together with MAC as there is a strong rationale for pudafensine in vulvodynia addressing most importantly the pain associated with vulvodynia, but also the sexual dysfunction linked to this debilitating condition. Considering the vast unmet need and the number of women affected, the market potential for an approved treatment is immense,” said Claus Olesen, CEO of Initiator Pharma.
The planned randomized, placebo-controlled Phase 2a study, will enroll 24 women with vulvodynia, assessing the pain-relieving effects and safety of pudafensine. It will employ a four-way crossover design, where each participant will receive single oral doses of pudafensine and placebo across different treatment periods, separated by washout intervals.
The crossover study design offers several advantages:
- Each participant serves as her own control – reducing variability between individuals and allowing meaningful results from a smaller sample size.
- Direct comparison of multiple treatments within the same patient group – enabling precise head-to-head evaluation of pudafensine against placebo.
- Particularly well-suited for pharmacokinetic and pain studies – enhancing the ability to detect subtle differences in drug effect and tolerability.
“Vulvodynia is a chronic, under-recognized pain condition with limited treatment options. The proposed study design allows us to rigorously assess the potential of pudafensine to provide relief for patients, while making efficient use of a small but well-controlled trial population in cost and time efficient manner,” said Ulf Simonsen, CMO of Initiator Pharma.