Leo has done an outstanding job managing available resources while efficiently moving multiple clinical trials forward. For a small biotech, IPIX has an enviable pipeline that should handsomely reward investors. Some comments about the pipeline:
Brilacidin
Brilacidin- Oral mucositis
Accelerated enrollment and now full enrollment of the Phase 2 trial reflect (1) increasing number of clinical trial sites and (2) very positive interim results. Back-end loaded enrollment after interim results is very positive. People forget that the enrollment criteria for this trial was very stringent. We knew it would be slow going from the beginning. The tradeoff with the stringent enrollment criteria and slow enrollment is that the targeted patient population is extremely likely to suffer from severe oral mucositis. The interim results were fantastic and, imo, results were adversely skewed by a single nonresponder. I'm betting that topline results will be as good or better than interim results.
Also, B-OM is a distinct formulation of Brilacidin that could easily be carved out of the Brilacidin franchise for partnering without compromising the Brilacidin franchise.
Brilacidin- ulcerative proctitis
Very positive results from a POC trial surely has Big Pharma attention. Perhaps by itself one could be skeptical of results but Brilacidin-OM data and pre-clinical data strongly supports Brilacidin's anti-inflammatory properties. With minimal GI absorption, technology is available to formulate Brilacidin for Crohn's and ulcerative colitis. It's known territory for Big Pharma.
B-ABSSSI: Phase 2b data is very strong and I am happy with Leo's decision to hold off on a very expensive Phase 3 trial while the Brilacidin franchise is further developed. I am confident that Brilacidin will prove superior to Vancomycin.
Kevetrin: a short duration open label dose escalation trial focusing on biomarkers and safety potentially positions Kevetrin for partnering in the coming months. Is it safe? Does it appear to have a positive impact on biomarkers? Is there a clinical response with such a short duration of treatment and likely sub-optimal dosing?
Prurisol: The phase 2b trial is further exploring the dose/response relationship and is critical to knowing what we really have. The trial should be fully enrolled. We've discussed hoped for results at length in previous threads and results in the neighborhood of Otezla should give us a very lucrative deal.
Deals take time, negotiations are not publicized, and they don't usually occur in our imagined timeframes. One morning in the hopefully not too distant future we'll get some kind of deal. And then there will be another. And perhaps another.
I have full confidence in Leo and the IPIX team.
biodoc
