Under the agreement, GSK will develop and market Arrowhead’s ARO-HSD for nonalcoholic steatohepatitis (NASH) treatment.
A ribonucleic acid interference (RNAi) therapeutic, ARO-HSD acts on the HSD17B13 as a potential therapy for individuals with alcohol-related and nonalcohol associated liver diseases such as NASH.
ARO-HSD is being analysed in the Phase I/II AROHSD1001 clinical trial for safety, tolerability, pharmacokinetics and pharmacodynamic effects.
The single and multiple dose-escalating trial will enrol a total of up to 74 healthy subjects and individuals with/suspected NASH.
According to the deal, Arrowhead is entitled to $120m in upfront payment from GSK, which will also make further payments of $30m on commencing Phase II trial.
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On obtaining positive data from the Phase II trial and dosing of the first subject in a Phase III trial, GSK will pay an additional $100m to Arrowhead.
In addition, Arrowhead is eligible for commercial milestone payments of up to $190m at initial commercial product sale and sales-based milestone payments of up to $590m.
These payments are contingent on positive Phase III trial data and regulatory approval for the product in key markets, Arrowhead noted, adding that the company is also eligible for tiered royalty payments on the net sales of the products.
GSK will obtain a licence to exclusively develop and market the therapy in all territories excluding Greater China, where Arrowhead will hold a licence under the pact.
Arrowhead president and CEO Christopher Anzalone said: “GSK has a global reach and impressive capabilities in the clinical development and commercialisation of important medicines.
“As the work continues towards progressing further Phase II studies and planning Phase III studies for ARO-HSD, we believe this agreement with GSK furthers the potential of ARO-HSD as a promising new investigational therapeutic for patients with NASH and other liver diseases.”
Subject to necessary closing conditions and approvals, the deal is anticipated to conclude in the first quarter of next year.
In June, Arrowhead and Horizon Therapeutics signed an international partnership and licence agreement to develop ARO-XDH, an RNAi therapeutic.