In this week’s edition of Pipeline Moves, we zero in on two assets by Novartis – one in ovarian cancer and the other in nonalcoholic fatty liver disease (NAFLD). Both assets saw their respective Phase Transition Success Rates (PTSR) tumble after trial terminations.
Further in the roundup, we cover two trial completions, one by Eliem Therapeutics in diabetic neuropathic pain and the other by Goldfinch in diabetic nephropathy, with both seeing an uptick in their PTSRs. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
Phase I of Novartis ovarian cancer asset cancelled
Novartis’ PDR001 (spartalizumab) saw a major drop in its PTSR in epithelial ovarian cancer after the termination of an investigator-led Phase I trial. Spartalizumab’s PTSR in epithelial ovarian cancer dropped by 38 points, settling at 25%, following the Phase I study termination due to safety implications.
The study (NCT03294694) was terminated on 31 March and GlobalData reviewed the asset on 1 April. The study was sponsored by the Dana-Farber Cancer Institute and Novartis was a collaborator. It also recruited patients with metastatic hormone-receptor positive (HR+), HER2 negative breast cancer.
The open-label study investigated multiple doses of monoclonal antibody spartalizumab in combination with Novartis’ own Kisqali (ribociclib succinate). Spartalizumab is a PD-1 antagonist. Kisqali inhibits the activity of CDK4/6.
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Novartis terminates liver disease trial
Novartis’ LJN452 (tropifexor) saw a drop in its PTSR after a Phase II NAFLD trial was terminated. The PTSR dipped by 10 points to 33%. GlobalData appraised the asset on 29 March after a ClinicalTrials.gov update on 28 March.
The open-label study (NCT04147195) enrolled 41 patients with NAFLD who may also have nonalcoholic steatohepatitis (NASH). The trial had a primary endpoint focusing on safety, with a bevy of secondary endpoints such as change in liver fat.
Tropifexor is an farnesoid X receptor (FXR) agonist. LYS006 is a leukotriene A4 hydrolase (LTA4H) inhibitor.
Eliem completes Phase II
Eliem’s ETX-810 saw its PTSR in diabetic neuropathic pain climb after the completion of a Phase II study. The PTSR rose by 10 points to 28%. The study (NCT04688671) had its status changed to completed in a 25 March update on ClinicalTrials.gov. GlobalData appraised the asset on 28 March.
The 167-subject study had a primary endpoint looking into pain score changes until week four. ETX-810 is an oral nonopioid painkiller, which is a prodrug of palmitoylethanolamide (PEA), an endogenous bioactive lipid. PEA is said to regulate neuroinflammation and pain signaling.
Goldfinch completes diabetic nephropathy trial
Goldfinch Bio’s GFB-024 saw its PTSR in diabetic nephropathy leap six points to 62% after a Phase I trial completed. ClinicalTrials.gov updated the trial to completed on 28 March, and the PTSR change took effect the next day.
The trial (NCT04880291) anticipated enrolling 56 participants, but it ultimately only enrolled 39. Participants were overweight, obese, and/or diagnosed with Type 2 diabetes. The Phase I trial has a primary endpoint looking into adverse events, with secondary endpoints focusing on pharmacokinetic outcomes.
GFB-024 is an injectable monoclonal antibody targeting cannabinoid receptor 1, which is implicated in the pathogenesis of diabetic nephropathy.
Additional writing by Clinical Trials Arena healthcare researcher Irena Maragkou
Need to Know:
GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR. PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.