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.

We also look at the advancement prospects of assets by Glyscend Therapeutics, Qlaris Bio , and Apollomics after they reported trial completions of their respective assets.

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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.