RE:Galapagos - ISABELA phase 3ualcin, no doubt Galapagos is creating competitive tension, which PLI and its future 4050 partner will have to respond to. Hopefully, this will result in PLI closing a partnership deal on 4050 in the very near future.
One notable difference in the Galapagos study is that it's drug is only being tested as an add-on therapy to the two existing standard of care drugs. Whereas, 4050 will be trialled on a complete stand alone basis as well as an an add -on to nintedanib. The following was in a recent PLI press release:
Based on recommendations from the FDA, Prometic now will undertake an “all comers study”. The enrollment criteria will be greatly simplified such that the study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV®) or not. Therefore, the study will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication “for the treatment of IPF”. Patients will be randomized to receive placebo, or one of two doses of PBI-4050 (800 mg or 1,200 mg) for a total of 52 weeks. An interim analysis will be conducted at 26 weeks. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), the total amount of air exhaled during a forced breath, expressed in mL and measured over 52 weeks (mL/year). Patients taking pirfenidone will be excluded because of a known drug-drug interaction between pirfenidone and PBI-4050.