"Finally, finally we have Phase 2 data. We put a dent in the theory that phage therapy doesn't work. Maybe it does work. Maybe it's worth taking a risk."

Jonathan Solomon joins Jessica Sacher and Joe Campbell on the Podovirus Podcast to discuss BiomX's exciting Phase 2 clinical trial results, where they used bacteriophages to treat diabetic foot osteomyelitis (DFO). With 40% of DFO patients facing amputation, this is an area of massive unmet need. Jonathan shares how their trial was designed (he credits the team at Adaptive Phage Therapeutics, which began the trial prior to its merge with BiomX), and how it achieved what many of us have almost given up on: positive, statistically significant clinical efficacy data for a phage therapy treatment*.

Here's a taste of what we covered:

1. 🔬 The "Head of the Snake" theory – why many diabetic foot ID docs believe targeting Staph aureus alone works even in polymicrobial infections

2. 💉 Their phage delivery approach: combining IV "debulking" with topical phage application to help break down biofilms

3. 🏥 How 12 out of 13 phage-treated patients with bone-deep ulcers showed significant tissue rebuilding vs. only 5 of 9 in the placebo group

4. 💰 The commercial viability challenge: "If you're not seeing a 30% improvement, no one would pay for an expensive phage therapy"

5. 🧪 How personalized medicine meets practicality – the decision to use just one optimized phage per patient

6. 🔭 BiomX's dual-program approach with both DFO and cystic fibrosis trials showing promising results

Learn more!

1. BiomX Positive Phase 2 Diabetic Foot Osteomyelitis Results

2. The details of BiomX/Adaptive Phage Therapeutics’ DANCE trial

3. Recent key opinion leader discussion of Diabetic foot osteomyelitis results

4. BiomX Positive Part 2 Phase1b/2a trial of Cystic Fibrosis results

5. BiomX (NYSE: PHGE) website

*Added context

Timestamp ~22:50 : Technophage (a biotech company in Portugal) did run a prior Phase 1/2a trial for diabetic foot infections. While the study showed their TP-102 phage cocktail was well tolerated and safe, and reported improved outcomes, the authors report it was underpowered to determine the superiority of TP-102 over placebo, as it ended before reaching the final target of 18 patients due to slow recruitment. Technophage is currently running a larger version of this study. 

Of note, there has been one other successful phase 2 phage trial: the Wright et al. ear infection trial published in 2009. This clinical program would have moved to phase 3, but corporate priorities shifted around the time of the ‘08 crash, and it was dropped (check out this interview with trial lead David Harper to learn more). Phage companies have been trying to re-reach this milestone ever since. Finally, it’s been reached.