Great summary, sox040713
Worth repeating:
Quote:
Why not just one year to show good faith instead of four long years? Management knows they don't have the resources for Phase 3s. That's why they're trying to partner. Here's a brief summary of the drug candidates.
B-UP: In the Phase 2 POC trial, the drug achieved 67% clinical remission as evident by endoscopic images. Every patient had improvement in quality-of-life. IBD is a hot market. J&J recently agreed to a $990M deal with $50M upfront payment to acquire Protagonist's PRECLINICAL oral IBD drug.
B-OM: Interim analysis was very encourging with severe OM prevention in 78% of patients. The current standard of care only shortens the duration of severe OM but doesn't prevent it. Patient enrollment is 100% and the top-line result is expected in October/November. The FDA granted Fast Track Designation and IPIX plans to apply for Breakthrough Therapy Designation if the trial is successful.
B-ABSSSI: Single dose matched 7-day Daptomycin in Phase 2b. If IPIX can find a partner for other drugs, they'll advance the drug to Phase 3 using the upfront money.
P: In the Phase 2a trial, 35% of mild/moderate psoriasis patients in the 200 mg arm achieved at least a 2-point IGA improvement. Sub-population analysis shows 46% of moderate psoriasis patients in the 200 mg arm achieved at least a 2-point IGA improvment. The dosage has increased to 300 mg and 400 mg in the Phase 2b trial. It'll assess moderate/severe psoriasis patients using an easier scale in PASI 75. The FDA granted the 505(b)(2) pathway, so only one Phase 3 with fewer patients might be required. The bar isn't set very high by Otezla with ~30% PASI 75. Interim analysis is expected in Q3 and top-line result is expected in Q4.
K-OC: K is the riskiest but has the most potential. The drug was shown to be safe in Phase 1 with 67.5% of patients had increases in p21 expression. Big name immunotherapy drugs such as Opdivo failed a key Phase 3 trial in lung cancer and Keytruda was halted due to patient deaths. The main purpose of this Phase 2 trial is to confirm K's MOA as requested by an interested party. A safe p53-activating drug could be very valuable.
