In this week’s edition of Pipeline Moves, the Clinical Trials Arena team had a look at four Phase I studies. This includes Pfizer in nonalcoholic steatohepatitis (NASH) and Cerevel Therapeutics in panic disorder. Also, iOnctura and Blade Therapeutics, respectively, also made strides in idiopathic pulmonary fibrosis (IPF).
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Pfizerprogress in NASH program
Pfizer’s PF-06882961 (danuglipron tromethamine) had a seven-point increase in its Phase Transition Success Rate (PTSR) in NASH after its Phase I trial completed. The PTSR change to 70% occurred on 19 January, after its ClinicalTrials.gov status was updated on 18 January. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The 23-subject Phase I trial (NCT04604496) studied the plasma pharmacokinetics of PF-06882961 as its primary outcome. Secondary endpoints included the incidence of adverse events and laboratory abnormalities.
PF-06882961 is a glucagon-like peptide receptor 1 (GLP-1) agonist. It aims to improve glucose-dependent insulin secretion and reduce elevated glucagon secretion.
iOnctura completes Phase I
iOnctura’s IOA-289 for IPF saw its PTSR leap five points to 56% after its Phase I trial completed. The ClinicalTrials.gov update was on 18 January, and the PTSR change took effect 19 January.
The placebo-controlled Phase I study (NCT05027568) tested the safety and pharmacokinetics of ascending doses of IOA-289 in 40 healthy male adults. The incidence of treatment-emergent adverse events was the primary endpoint.
IOA-289 is an autotaxin (ATX) inhibitor under development for IPF, solid tumours, and pancreatic cancers.
Blade reveals topline data
Blade Therapeutics’ cudetaxestat saw its PTSR jump six points to 58% in IPF after topline Phase I data was released. Blade reported the data in a 12 January press release, with the PTSR change taking effect on 17 January.
The 83-subject Phase I study (NCT04939467) tested cudetaxestat’s effect on the pharmacokinetics of Roche’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) as its primary endpoint. Cudetaxestat was well-tolerated with no reported drug-related serious adverse events, the company press release stated.
Blade expects to advance cudetaxestat into phase II in IPF in Q2. Both Esbriet and Ofev received FDA approval in IPF in 2014. Cudetaxestat is an autotaxin inhibitor designed for fibrotic diseases.
Cerevel completes panic disorder study
Cerevel Therapeutics’ asset darigabat had its PTSR in panic disorder spring after the completion of a Phase I study. The PTSR grew by seven points to 81%.
The study (NCT04592536) had its status changed to “completed” in a ClinicalTrials.gov update on 11 January. GlobalData updated its system on 14 January.
The 56-subject study aimed to investigate the effect of multiple doses of darigabat on healthy subjects who have had panic symptoms induced by carbon dioxide inhalation. The study assessed the change in the Panic Symptom List -IV (PSL-IV) on an eight-day timeframe as the primary outcome.
Darigabat is an oral subtype-selective positive allosteric modulator at GABAA receptors. The asset targets the alpha 2, 3 and 5 subunits of the receptors, which leads to its antianxiety effects.