GRI Bio has announced encouraging six-week interim safety outcomes from the ongoing Phase IIa trial of the small molecule RAR-βɣ dual agonist, GRI-0621, to treat idiopathic pulmonary fibrosis (IPF).
During the pre-planned interim analysis, the oral 4.5mg dosage of the therapy once a day was found to be safe and tolerated well in the first 24 subjects treated, without exhibiting any adverse events related to hyperlipidaemia, as evaluated by LDL, HDL, and triglyceride levels.
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There were no clinically meaningful changes observed in these levels, aligning with the safety data which was reported post the completion of first 12 participants’ two-week treatment period, and all the participants remained within protocol accepted ranges.
The trial was recommended by the interim analysis committee to proceed as per the plan.
The Phase IIa, double-blind, randomised, multi-centre, placebo-controlled study is aiming to enrol around 36 IPF subjects.
Participants are randomised in a 2:1 ratio to receive either the therapy or a placebo, with the primary endpoint being the therapy’s tolerability and safety post the 12-week treatment period.
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By GlobalDataSecondary goals include baseline changes in serum biomarkers, pharmacokinetics, and activity as measured by the inhibition of invariant natural killer T (iNKT) cell activation, with a sub-study simultaneously investigating NKT cells in bronchoalveolar lavage fluid for up to 12 eligible participants.
Exploratory endpoints will assess pulmonary function and other biological markers.
GRI Bio anticipates releasing six-week interim biomarker data in July this year, with topline outcomes from the Phase IIa biomarker trial anticipated in the third quarter.
The interim findings reinforce the therapy’s receptor selectivity being in line with toxicity profile previously observed in studies of oral tazarotene, which involved more than 1,700 subjects treated for up to a 52-week period.
GRI Bio CEO Marc Hertz said: “We are happy to report the IDMC confirmed no safety concerns in the first 24 subjects evaluated after six-weeks of treatment, building upon the two-week safety data reported earlier and adding to the large safety data available for oral tazarotene.”
