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January 11, 2022

Pipeline Moves: GSK’s likelihood of further study in tuberculosis rises

Stuart Therapeutics in dry eye disease and Vifor Pharma in beta thalassemia are also reviewed by Clinical Trials Arena.

By Clinical Trials Arena Team

Every Tuesday, the Clinical Trials Arena team will report Pipeline Moves: key drug pipeline and competitive landscape changes based on the latest clinical trial activity. In this year’s inaugural edition, we review trial completions from GlaxoSmithKline in pulmonary tuberculosis and Vifor Pharma in beta thalassemia. Also, Stuart Therapeutics and Vaccinex make progress in their early-phase assets in dry eye disease and head and neck cancer, respectively. To receive our weekly updates in your inbox, sign up to our Pipeline Moves newsletter here.

GSK reveals tuberculosis data

GlaxoSmithKline’s GSK-3036656 saw its Phase Transition Success Rate (PTSR) climb seven points to 55% after its Phase II pulmonary tuberculosis trial completed. ClinicalTrials.gov updated the trial from “recruiting” to “completed” on 3 January, and the PTSR change took effect 5 January.

The 76-patient Phase II trial (NCT03557281) randomized patients 3:1 to GSK-3036656 or Sanofi’s Rifafour e-275, which is the standard of care in tuberculosis. GSK-3036656 works by inhibiting the enzyme Luecyl t-ribose nucleic acid synthesase, which can suppress protein synthesis in tuberculosis.

PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. The PTSR is calculated for a drug by considering characteristics like therapy area, indication and molecule type.

Stuart Therapeutics shares positive Phase II

Stuart Therapeutics’ ST-100 saw its PTSR in keratoconjunctivitis sicca rise after an announcement of positive Phase II data. The PTSR grew by nine points to 38%. The double-blinded study had its positive data announced as part of a company press release published on 3 January. GlobalData updated its system on 4 January.

The 160-subject study sought to examine ST-100’s in keratoconjunctivitis sicca, also known as dry eye disease. The 50mg/ml dose achieved the trial’s primary endpoint, which is the Schirmer’s Test Responder Rate (p=0.0266) at 28 days. The asset also saw an improvement in Overall Ocular Discomfort (Ora Calibra Scale) (p=0.0332) at day 14. Patients were given either 20mg/ml or 50mg/ml of ST-100 twice a day, with a further group being treated with a placebo comparator.

ST-100 is an ophthalmically administered collagen mimetic peptide, which restores structural and cell signalling capabilities of disease damaged helical collagen.

Vifor Pharma completes beta thalassemia trial

Vifor Pharma ’svamifeport saw its PTSR in beta thalassemia rise after the completion of a Phase II study. The PTSR grew by six points to 43%. The double-blinded study (NCT04364269) had its status changed to “completed” in a 5 January update on ClinicalTrials.gov. GlobalData had its latest update on 6 January.

The 25-subject study aimed to investigate the different doses of vamifeport in patients with nontransfusion-dependent beta thalassemia. Beta thalassemia is an inherited blood disorder, which causes reduced hemoglobin levels and leads to anemia. Vamifeport is an oral ferroportin inhibitor.

Vaccinex unveils Phase Ib safety data

Vaccinex ’s asset pepinemab saw its PTSR in recurrent head and neck cancer squamous cell carcinoma (HNSCC) bump on the heels of positive Phase Ib interim safety data. The PTSR grew by five points to 37%. The open-label study (NCT04815720) had its data announced in a company press release published on 4 January. GlobalData updated its system on 6 January.

The study examined pepinemab in combination with Merck’s Keytruda (pembrolizumab) in advanced, recurrent, or metastatic HNSCC. The completed Phase Ib safety run-in segment reported that pepinemab was well-tolerated and safe. The trial also determined the recommended Phase II dose for pepinemab of 20mg/kg for the dose expansion phase. The subsequent dose expansion phase of the study will evaluate the Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as the primary objective.

Pepinemab is an intravenously administered monoclonal antibody, which inhibits semaphorin 4D (SEMA4D). SEMA4D is a glycoprotein, high levels of which are seen expressed in various tumors and is linked to promoting tumor growth.

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