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Posted On: 08/11/2017 7:32:03 PM
Post# of 72444
A brief summary of IPIX's pipeline.
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 plan to 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.
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 plan to 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.
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