I needs to be remembered that GALT failed Phase 2a (NASH-FX) in 30 NASH patients with advanced fibrosis. For this short trial the results where analyzed with magnetic resonance imaging for inflammation and fibrosis and end-points where not achieved. The only finding was that GR-MD-02 was safe and well tolerated.
Even though this trial (NASH-CX) is of longer duration, has more patients and is looking for different endpoints (HVPG being one of them) is important, I am really not worrying too much about its results one way or another. The real possibility exist in the performance of GR-MD-02 as a combinational drug. If it potentiates Pembrolizumab (as 1b trial over 2 years on 9 refractory patients seems to suggest), or any other NASH drug, the potential is humongous. This trial was carried out with sub-optimal dosage, only 3 patients received 2 mg/kg (minimum dosage stablished in mice for the drug to have ANY effect) and ALL have either parcial responses (2) or total response (1) in 4 months !!!. Two patients from cohort-1 receiving less than the minimum dosage had responses (one total response).
I guess what I am trying to say is that if the current trial (with higher dosage of GR-MD-02) in combination with Pembrolizumab shows ANY improvement (over Pembrolizumab alone) the sky is the limit. This irrespective of GALT's own NASH-CX trial as really the future of NASH treatment will be a combinational approach and GALT will be taking a ride in the shoulders (or the stomach, if you know what I mean) of MERK or whomever wants to potentiate its drug with GR-MD-02.
So, let's wait and cross fingers on that the combination works …
I am VERY long GALT
