This week on Pipeline Moves, we kick off by looking at Phase III trial terminations by Bayer and Johnson & Johnson. We also look at Pfizer‘s Phase I trial termination in oncology. On a good note, we investigate completions in wet macular degeneration and eosinophilic oesophagitis, and new Phase I/II data from a glioblastoma trial.
Termination of Phase III cardiovascular trial
Bayer’s asundexian saw its Likelihood of Approval (LoA) drop after a Phase III cardiovascular trial was terminated. The LoA decreased by 21 points to 10% in atrial fibrillation and 12 points to 4% in ischaemic stroke.
LoA is calculated by GlobalData’s analysis using a combination of machine learning and a proprietary algorithm. LoA can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.
The independent data monitoring committee (IDMC) recommended stopping the OCEANIC-AF study due to an inferior efficacy of asundexian versus the control arm, according to a company statement on 19 November. GlobalData evaluated the asset on 21 November.
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The Phase III OCEANIC-AF trial (NCT05643573) was a part of the overall OCEAN Phase III programme. The study aimed to evaluate asundexian, an oral coagulation factor XI inhibitor, compared to Bristol Myers Squibb’s Eliquis (apixaban) for the prevention of stroke or systemic embolism in subjects with atrial fibrillation.
IDMC recommended continuing the Phase III OCEANIC-STROKE trial (NCT05686070) investigating asundexian to prevent a clot-related stroke in participants after an acute ischaemic stroke or high-risk transient ischaemic attack.
Hopes for Crohn’s disease candidate fall after Phase III termination
Johnson & Johnson’s guselkumab saw its LoA drop in Crohn’s disease after a Phase III trial was terminated. The LoA decreased by eight points to 40%.
The Phase III trial was terminated because Janssen, which is the key subsidiary of Johnson & Johnson, made an internal business decision to discontinue the PROGRESS study.
As per ClinicalTrials.gov, the decision was not related to any efficacy or safety concerns. Guselkumab is an IL23A inhibitor and is marketed as Tremfya for the treatment of plaque psoriasis and psoriatic arthritis.
The trial’s ClinicalTrials.gov status (NCT05784129) was updated on 13 November, with GlobalData evaluating the asset the next day.
The Phase III trial intended to evaluate Tremfya in participants with Crohn’s disease after surgical resection. The study enrolled four patients out of an anticipated 370 before being terminated.
Pfizer terminates Phase I oncology trial
Pfizer’s PF-07260437 saw its Phase Transition Success Rate (PTSR) decrease in several cancer indications after a Phase I trial was terminated. The drug’s PTSR dropped by 24 points to 36% in ovarian cancer, 34 points to 37% in endometrial cancer, and 33 points to 39% in HER2-negative breast cancer.
PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The Phase I trial’s (NCT05067972) status was updated from completed to terminated on ClinicalTrials.gov on 9 November, and GlobalData evaluated the asset on the following day.
According to the study’s ClinicalTrials.gov listing, the study was terminated by the sponsor due to an internal business decision and not because of safety concerns.
The purpose of the study was to evaluate the safety, tolerability, and pharmacokinetics of PF-07260437 in ovarian cancer, metastatic breast cancer and endometrial cancer. The study enrolled 30 patients.
PF-07260437 elicits antineoplastic activity by activating CD3 and by killing cells expressing B7-H4.
Phase II trial in wet AMD completes
Boehringer Ingelheim’s BI-836880 saw its PTSR rise by six points to 41% in wet macular degeneration after the completion of a Phase II trial.
The study’s (NCT03861234) status was changed from active, not recruiting to completed on 13 November. GlobalData evaluated the asset on 14 November.
The purpose of the open-label, non-randomised study was to assess the safety, tolerability and pharmacodynamics of single rising and multiple rising doses of the candidate administered intravitreally.
The single dose part, which lasted six weeks, saw patients receive an 80 mg/ml dose. Patients received three times the same dose of BI 836880 in the second part.
The primary endpoints were the number of patients with ocular dose limiting events after 43 days and drug-related adverse events after 169 days for the single rising dose part and multiple rising dose part respectively.
The study enrolled 43 patients with treatment-resistant wet macular degeneration.
BI-836880 is a bi-specific nanobody that inhibits vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2). Dual inhibition of ANG-2 and VEGF reduces inflammation, stabilises blood vessels, and prevents their leakage.
PTSR rise for eosinophilic oesophagitis candidate
EsoCap’s mometasone furoate saw its PTSR increase in eosinophilic oesophagitis after a Phase II trial was completed. The drug’s PTSR increased by nine points, reaching 56%.
The Phase II trial’s (NCT04849390) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 13 November and GlobalData evaluated the asset on 15 November.
The purpose of the study was to investigate the efficacy and tolerability of mometasone furoate in patients with eosinophilic oesophagitis. The study enrolled 43 patients.
Mometasone furoate acts as a glucocorticoid receptor agonist and inhibits the activity of inflammatory mediators.
PTSR increase after Phase I/II glioblastoma trial
MediciNova’s ibudilast saw its PTSR rise after the company presented new data from a Phase I/II glioblastoma trial. The PTSR increased by 16 points to 40% in recurrent glioblastoma multiforme (GBM).
The company announced new data from the Phase II part of the trial on 19 November, with GlobalData evaluating the asset on 21 November.
The Phase I/II trial (NCT03782415) evaluated ibudilast in combination with temozolomide in patients with newly diagnosed or recurrent GBM. In addition to the tolerability and safety of the combination treatment, the Phase II part of the trial measured the progression-free survival (PFS) rate at six months using the RANO criteria.
According to the press release, the trial enrolled 62 patients, including 36 subjects with newly diagnosed GBM and 26 with recurrent GBM. The PFS at six months was 44% for new GBM and 31% for recurrent GBM.
Ibudilast is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).
Read the last edition:Pipeline Moves: Advancement prospects drop for hearing loss drug after trial termination
Need to know:
GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses datapoints from individual