As with every Tuesday, the Clinical Trials Arena team brings you this week’s edition of Pipeline Moves. We begin with Sorrento Therapeutics and the termination of its Phase Ib metastatic pancreatic adenocarcinoma trial. We continue with Loxo Oncology’s status update of its Phase I/II cancer study.
Moving on, we cover the trial completions of Kinnov Therapeutics’ Phase II alcohol addiction trial, as well as Genmab’s Phase II cancer study. We close off this week’s edition with Pfizer’s pruritus program.
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Sorrento terminates pancreatic cancer study
Sorrento’s CAR-T asset K-171355 had its Phase Transition Success Rate (PTSR) plummet following the termination of a Phase Ib trial in patients with metastatic adenocarcinoma of the pancreas. The PTSR decreased by 33 points, settling to 33%, after the trial termination. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
According to its ClinicalTrials.gov listing, the Phase Ib trial (NCT03818165) was terminated due to limited participant recruitment. The listing shows it was anticipated to recruit six patients but only recruited two. The study had its status changed to terminated in a ClinicalTrials.gov update on 15 March. GlobalData updated its system on 16 March.
Loxo updates Phase I/II oncological study
Loxo’s oncology asset LOXO-292 (selpercatinib) saw a rise in its PTSR after a Phase I/II cancer trial’s status was changed to ongoing. The trial is recruiting paediatric participants (patients aged six months to 21 years) with advanced solid or primary central nervous system tumours.
The PTSR increased by 11 points to 23% in solid tumour and 20 points to 33% in central nervous system cancer. GlobalData appraised the asset on 10 March after a ClinicalTrials.gov update on the same day.
The open-label Phase I/II trial (NCT03899792), in collaboration with Eli Lilly, is enrolling 100 paediatric subjects. The study will assess dose escalation (Phase I) and dose expansion (Phase II). The asset inhibits the proto-oncogene tyrosine-protein kinase receptor RET and promotes apoptosis in tumour cells.
Kinnov concludes alcohol addiction trial
Kinnov’s combination of cyproheptadine hydrochloride and prazosin hydrochloride (KT-110) had an increase in its PTSR following the completion of a Phase II trial in patients with alcohol addiction. The PTSR increased by nine points, reaching 25% after the completion of the 154-participant Phase II (NCT04108104) study. The ClinicalTrials.gov listing was updated on 14 March, with asset appraised two days later.
KT-110 functions as an antagonist of 5-HT2 receptors and alpha1-andrenergic receptions. These receptors mediate excitatory neurotransmission. Alcohol use disorder is characterised by impairment in one’s ability to control or stop alcohol use, regardless of adverse effects to one’s health, social, and occupational life.
Genmab completes Phase II cancer trial
Genmab’s Tivdak (tisotumab vedotin) saw a rise in its PTSR in fallopian tube cancer and epithelial ovarian cancer after the completion of a Phase II trial. The PTSR increased by six points to 42% in both indications. GlobalData appraised the asset on 15 March after a ClinicalTrials.gov update on 11 March.
The Phase II (NCT03657043) enrolled 98 patients with fallopian tube cancer or epithelial ovarian cancer. Tivdak is a tissue factor inhibitor, which inhibits target cell signalling and induces cytotoxicity in tumour cells. Tivdak is approved in previously treated recurrent or metastatic cervical cancer.
Pfizer makes strides in pruritus program
Pfizer’s Cibinqo (abrocitinib) displayed an increase in its PTSR in pruritus after the completion of a Phase I trial recruiting healthy volunteers. The PTSR increased by seven points, reaching 71%, after the completion of the study. The study had its status changed to completed in a ClinicalTrials.gov update on 8 March. GlobalData appraised the asset on 10 March.
The Phase I (NCT05067439) investigated the effect of multiple doses of Cibingo on the pharmacokinetics of caffeine, efavirenz, and omeprazole in 13 healthy subjects. Pruritus (itchy skin) can be a serious dermatological condition characterised by an intense, irritating itching sensation leading to redness, cracked skin, bleeding and infection. Cibingo is approved for treatment of refractory, moderate-to-severe atopic dermatitis.
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.
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