In this week’s edition of Pipeline Moves, the Clinical Trials Arena team reviews the suspension of a Phase II trial studying a cancer asset, and the termination of a Phase II acute pharyngitis study.
Phase II clinical trial of cancer asset suspended
Cumberland Pharmaceuticals’ ifetroban had its Phase Transition Success Rates (PTSR) decline in five oncological indications after an investigator-sponsored Phase II study was suspended. The suspension is due to unavailable funding, according to its ClinicalTrials.gov listing. GlobalData evaluated the asset on May 10 after a ClinicalTrials.gov update on May 9.
The PTSR decreased by 19 points for lung cancer, settling at 12%. It also decreased by 20 points for pancreatic cancer (now 10%), 19 points for gastric cancer (11%), 16 points for solid tumors (5%) and 12 points for oesophageal cancer (9%). PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The 60-participant Phase II study (NCT03694249) was sponsored by the Vanderbilt-Ingram Cancer Center, with Cumberland listed as a collaborator. The study had three coprimary endpoints, which are occurrence of adverse events, adherence to daily treatment with ifetroban pill, and changes in the FACT-G (Functional Assessment of Cancer Therapy-General) score. Ifetroban is a thromboxane A2 receptor antagonist.
Phase II acute pharyngitis trial terminated
Megainpharm’s oromucosal spray miramistin (Myramistin) saw a decrease in its PTSR in acute pharyngitis after a Phase II study was terminated. The termination was due to limited recruitment of patients due to the COVID-19 pandemic. The PTSR decreased by seven points to 2%.
GlobalData evaluated the asset on the May 6 after a ClinicalTrials.gov update on May 5. The Phase II (NCT04470089) anticipated to recruit 240 patients but eventually enrolled 170 participants.
The study was set to evaluate if miramistin can provide short-term relief versus placebo. Miramistin acts as an antiseptic with antifungal and anti-inflammatory effect.
Type 2 diabetes asset completes Phase I test
Glyscend’s GLY-200 saw its PTSR increase in type 2 diabetes following a Phase I clinical trial completion. GLY-200’s PTSR increased by 16 points reaching 60%. The company announced the trial completion in a press release on May 11 and GlobalData reported the PSTR change on May 13.
The placebo-controlled Phase I study (ACTRN12621000800820) evaluated single and multiple ascending doses of GLY-200 in 64 healthy adult participants. In the trial’s primary endpoint, GLY-200 is reported as well-tolerated with no serious adverse events. Secondary endpoints included a variety of exploratory markers.
GLY-200 is an oral polymer designed to recreate the effects of bariatric surgery in a noninvasive way. This is by boosting the duodenum’s natural mucus barrier and preventing the interaction of food with the duodenum’s surface.
Phase II ophthalmic trial completes
Qlaris Bio’s QLS-101 saw its PTSR increase in ocular hypertension and open-angle glaucoma after a Phase II trial completion. The PTSR rose nine points to 33% in ocular hypertension, and ten points to 36% in open-angle glaucoma. ClinicalTrials.gov updated the Phase II trial from active, not recruiting to completed on May 6, and the PTSR change took effect May 9.
The 84-patient Phase II study (NCT04830397) was designed to compare QLS-101 with ophthalmic solution timolol maleate. As a primary endpoint, the trial assessed the number of treatment-emergent adverse events through 100 days. The secondary endpoint was the number of participants showing intraocular pressure reduction from baseline after 28 days.
QLS-101 is an ATP-sensitive potassium channel modulator, which could lower intraocular pressure by causing vasodilation of vessels implicated in the trabecular meshwork. Timolol matleate is a generic beta blocker used to treat glaucoma, high blood pressure, and migraines.
Apollomics completes Phase I clinical trial of cancer asset
Apollomics’ APL-501 (geptanolimab) saw its PTSR in advanced malignancy and ovarian cancer rise after the completion of a Phase I study. The PTSR rose by seven points to 35% in advanced malignancy and by six points to 62% in ovarian cancer.
The open-label study (NCT03053466) had its status changed to completed in a 9 May update on ClinicalTrials.gov, with the PTSR change taking place the next day. The 30-subject study evaluated the safety, tolerability, and recommended dose of geptanolimab in patients with advanced or relapsed or recurrent solid tumours.
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.