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  1. Analysis
March 8, 2022

Pipeline Moves: Pfizer’s infectious disease vaccine misses primary endpoint, approval shot drops

The Clinical Trials Arena team also looks into Celyad in colorectal cancer after its Phase Ib termination.

By Urtė Fultinavičiūtė

Clinical Trials Arena dissects the approval prospects of Pfizer’s Clostridioides difficile infection vaccine, as well as Celyad Oncology’s advancement potential in colorectal cancer, with both companies reporting bad news from their respective trials.

On to the good news, Clinuvel Pharmaceuticals and Coordination Pharmaceuticals report of clinical trial completions, and Sirnaomics revealing positive Phase II data. What this means for these three companies you can find out below.

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Pfizer reports Phase III vaccine data

Pfizer’s Clostridioides difficile infection (CDI) vaccine PF-06425090 saw its Likelihood of Approval (LoA) nosedive 18 points to 20% after a Phase III study missed its primary endpoint. Pfizer reported topline results in a 1 March company press release, and the LoA change took effect on 3 March. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm.

The Phase III CLOVER trial (NCT03090191) tested 17,571 subjects over 50 years old at risk of developing CDI. The trial did not meet its primary endpoint of prevention of primary CDI, the press release stated.

PF-06425090 had a favourable safety profile, and a prespecified secondary endpoint showed 100% vaccine efficacy in preventing medically attended CDI. The infection is characterised by diarrhea that can lead to severe, and potentially fatal disease. Pfizer has said it is evaluating the next steps in consultation with regulators.

Ceylad terminates CRC trial

Celyad’s CYAD-101 sees a drop in its Phase Transition Success Rate (PTSR) after the termination of a Phase Ib study. The PTSR decreased by 10 points to 56% in metastatic colorectal cancer. GlobalData appraised the asset 2 March after a press release on 28 February. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The 34-patient, open-label Phase Ib study (NCT04991948) was terminated after two fatalities that presented with similar pulmonary findings. Patients received CYAD-101 plus the chemotherapy cocktail FOLFOX, which is then followed by Merck’s Keytruda (pembrolizumab). CYAD-101 is designed to activate T-cells against tumour antigens, resulting in disruption of tumour growth.

Clinuvel completes afamelanotide trial

Clinuvel Pharmaceuticals’ afamelanotide saw a rise in its PTSR after Phase IIa trial completion in acute ischemic stroke (AIS). The PTSR grew by nine points to 35% in AIS. The PTSR was updated by GlobalData on 24 February after a ClinicalTrials.gov update on 23 February from “ongoing” to “completed”.

The open-label study (NCT04962503) enrolled six subjects with clots located in the higher segments in the brain and who are ineligible for alternative treatment. The trial’s primary objective was to assess the safety of afamelanotide.

Coordination Pharma completes trial

Coordination Pharma’ CPI-200 for solid tumours saw its PTSR jump seven points to 38% after a Phase I trial completed. ClinicalTrials.gov updated the trial from “recruiting” to “completed” on 24 February, and the PTSR change took effect on 25 February.

As a primary endpoint, the open-label Phase I study (NCT03953742) aimed to find the maximum tolerated dose of CPI-200 in patients with advanced tumours. The trial previously had an enrollment goal of 27, but it ultimately recruited 17 patients.

Secondary endpoints included the rate of clinical benefit and the rate of adverse events after four months. CPI-200 is a nanoscale coordination polymer administered intravenously.

Sirnaomics reports positive Phase II

Sirnaomics’ STP-705 saw a rise in its PTSR after positive Phase II interim results in basal cell carcinoma (BCC). The PTSR increased by five points to 39%. The update on GlobalData happened on 25 February after a press release on 23 February.

The Phase II open-label trial (NCT04669808) enrolled 15 patients with BCC who received various doses of STP-705. The interim data showed the drug achieved therapeutic responses, as well as improved cosmetic results with no significant cutaneous skin reactions.

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 data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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