Gedea Biotech AB is advancing pHyph, an antibiotic-free therapeutic intended to treat vaginal infections. The company was selected for a €2.5M EIC Accelerator grant to support development of pHyph. The award is associated with the European Innovation Council and administered by the SMEs Executive Agency (EISMEA). Gedea plans to use the funding to advance pHyph through its next development milestones. The announcement emphasizes the company’s focus on non-antibiotic approaches to vaginal infections. No other financial details or operating metrics were disclosed in the article. Gedea Biotech is developing pHyph, an antibiotic-free vaginal tablet intended to both treat and prevent bacterial vaginosis (BV) and vaginal fungal infections. pHyph contains the naturally occurring active ingredient GDA 001 (approved as a food additive) and acts by restoring vaginal pH to 4.0–4.5 and breaking down BV biofilm. In two phase 2 trials pHyph demonstrated clinical cure rates for BV on par with marketed antibiotics, with a superior safety profile and without causing secondary fungal infections. The company raised 1.5 MEUR (16.5 MSEK) in an oversubscribed rights issue to initiate and accelerate clinical activities, including starting patient recruitment in the approved registration CL3-2 study and performing microbiome analyses. Funds will also support reaching a data readout from the CL4 study to obtain proof-of-concept for treating vaginal fungal infections and preparations for pivotal phase 3 studies aimed at FDA approval. Vaginal infections affect at least 400 million women annually and the market is cited at over $1.5 billion, underpinning the commercial opportunity. Gedea was founded in 2015 in Lund, Sweden and is positioning pHyph for European approval and further U.S. regulatory steps.

Total raised

$4M

Funding rounds

2

Latest round

Grant

Latest activity

Feb 2024