A part 1a trial of Lexicon Pharmaceuticals’ LX9211 has met its main aims. The examine discovered the AAK1 inhibitor was effectively tolerated, teeing Lexicon as much as advance the neuropathic pain prospect.
Lexicon licensed LX9211 from Bristol-Myers Squibb in 2016 after working with the Big Pharma to characterize the AAK1 goal via a neuroscience drug discovery alliance. Since taking cost of this system, Lexicon has wrapped up IND-enabling research and put LX9211 via an early-phase test designed to evaluate security and establish the utmost tolerated dose.
Now, Lexicon has knowledge from that early-phase test. Lexicon is but to share an in depth have a look at the information however painted the end result of the trial as a surprise-free success in its abstract of the findings.
“The initial clinical data for LX9211 confirms the drug candidate’s preclinical profile,” Lexicon R&D Executive Vice President Praveen Tyle said in a statement. “LX9211 was well tolerated with predictable pharmacokinetics. At doses tested, drug levels of LX9211 were at biologically relevant concentrations and support the therapeutic potential of this highly selective inhibitor of AAK1.”
Lexicon generated the information in a clinical trial that enrolled healthy volunteers and grouped them into 10 cohorts that obtained daily doses of LX9211 starting from 5 mg to 200 mg. According to Lexicon, the pharmacokinetics help once-daily dosing, at most, and have been dose proportional throughout nearly all the evaluated vary. No drug-related severe adversarial occasions have been reported.
Boosted by the findings, Lexicon is planning to maneuver LX9211 right into a a number of ascending dose examine within the first quarter of subsequent 12 months. The trial will transfer Lexicon a step nearer to studying whether or not LX9211 can deal with neuropathic pain with out inflicting habit and different issues related to the usage of current painkillers.
Lexicon recognized AAK1 as a goal that would yield medication with such properties by testing 3,097 mouse knockout strains. The analysis led to the characterization of AAK1 and to the settlement with Bristol-Myers, which gave Lexicon full rights to LX9211 in return for regulatory and business milestones that start with the initiation of a part 2 trial.