Additional Phase 1 study looking at pK of VX 509 in combination with solumedrol (methylprednisolone) was initiated by Vertex in June according to clinical trials.gov website, This implies a strong possiblity of positive Phase 2 trial data in the trial using 509 combined with MTX in RA patients, which was fully enrolled as of June, with data release expected by end of summer. Data from another Phase 2 study looking at MRI of joints in RA patients treated with 509 is also expected this fall. All this activitiy points to another potential blockbuster breakthrough oral drug that Vertex can partner to more rapidly devleop and market for treatment of multiple autoimmune diseases including RA psoriasis and psoriatic arthritis, and inflammatory bowel disease.
VX 509 is more than likely going to do well. Basic reason is that this drug is very similar to Tofacitinib ie Janus Associated Kinase inhibitor 3. If ACR with methotrexate is 55%, it is equal in efficacy to the Tofacitinib and any efficacy higher than this should be exciting. If ACR exceeds 67%, this means a better efficacy than injectable Adalimumab.
I wish if VRTX could combine VX 509 with a Syk inhibitor like Fostamatinib to see a combine pill could exceed ACR 20 to 75-80% and this could become a new gold standard all oral therapy for RA, just like Hepatitis C. Syk target although consider to be a tyrosine kinase but totally different than JAK 3 and STAT pathways. Opportunist infection risk goes up, but acceptable and manageable these days.
"Additional Phase 1 study looking at pK of VX 509 in combination with solumedrol (methylprednisolone) was initiated by Vertex in June according to clinical trials.gov website, This implies a strong possiblity of positive Phase 2 trial data in the trial using 509 combined with MTX in RA patients,...."
On the other hand, could the initiation of a new phase 1 with solumedrol be an indication that the results of phase 2 (509+methotrexate) may not be looking as robust as expected?
Glad, I base my coment on the fact Jeff Leiden did not want to spend any more money on development of 509, except to finish current studies underway. By undertaking this Phase 1 pK study, (a relatively inexpensive trial to run) suggests to me a necessary step to demand a better deal for partnering 509, not because it's Phase 2 data is not robust,, but because completion of this Phase 1 trial is required by the FDA to determine pK data for 509 in combination with corticosteroids, drugs frequently used in all the autoimmune diseasess that 509 will be tested in. This will provide Vertex and it's potential pharmaceutical partner the information to determine optimal 509 doses to be used when steroids are prescribed concurrrently in patients receiving 509 in future clinical trials. I doubt any more money for clinical developoment on 509 would be approved by Dr. Leiden in past month if the Phase 2 data using 509 in combination with MTX in RA patients was not sufficiently 'robust'.