Boehringer Ingelheim has completed enrolment of the trial which is assessing BI 1467335 that works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.
BI 1467335 was acquired from Pharmaxis in May 2015 and is also in an ongoing Boehringer Ingelheim Phase 2a clinical trial for diabetic retinopathy.
Whilst Pharmaxis will not receive any milestone payments for a positive Phase 2a trial result under its contract with Boehringer Ingelheim, a positive result will increase the likelihood of receiving future milestones with the next one being triggered by the start of a phase 3 study.
Phase 2a expected to report in the second half of 2019
The Phase 2a NASH trial is a multi‐centre, double‐blind design in 114 patients with clinical evidence of NASH. The trial is being conducted in nine countries across North America and Europe.
The primary objectives are to establish proof of clinical principle, investigate suitable dosing, and to evaluate the safety of BI 1467335.
Patients have been randomized to either one of four dosages of BI 1467335 or to placebo for a 12‐week treatment period followed by a 4‐week observation period.
The trial is expected to report in the second half of 2019. A subsequent Phase 2b study will seek to confirm and extend these findings.
NASH is a major cause of liver fibrosis
Non‐alcoholic fatty liver disease (NAFLD), the most common liver disorder in Western industrialized nations, and its more serious form NASH, is highly prevalent amongst patients with type 2 Diabetes.
NASH is a major cause of liver fibrosis and cirrhosis and is an area of high unmet medical need with no treatments currently available.
The high prevalence of type 2 diabetes and obesity is expected to make NASH one of the most common causes of advanced liver disorders in the coming decades.
25% of the general adult population in the world has NAFLD and the prevalence of NASH has been found to range from 1.5% to 6.45% in current research, a number twice as high as 20 years ago.
Pharmaxis CEO Gary Phillips said: “We are delighted to see the progress made on this study and look forward to this trial reporting in the second half of this year.
“Whilst we do not receive any milestone payments under our contract with Boehringer Ingelheim for a positive trial result, this will still be the first proof of clinical principle of the Pharmaxis drug acquired in 2015.
“A positive result will increase the likelihood of receiving future milestones with the next one being triggered by the start of a phase 3 study.”