This week on Pipeline Moves, we kick off by looking at the completion of a Phase II/III trial of Pfizer’s Nurtec orally disintegrating tablet in rhinosinusitis.
Meanwhile, AmMax Bio terminated a Phase II trial of its candidate AMB-051 in tenosynovial giant cell tumours.
On a positive note, Bristol Myers Squibb’s BMS-986301 saw its progression prospects increase following a Phase I trial completion in advanced solid cancers.
[Link src="https://www.clinicaltrialsarena.com/all-newsletters/" title="Interested in more news in your inbox? Sign-up for our daily newsletter." font-size="20px"]Pfizer’s oral Nurtec wins in Phase II/III trial
Pfizer’s Nurtec orally disintegrating tablet (ODT) (rimegepant sulfate) saw a six-point increase in its Likelihood of Approval (LoA), settling at 72% in rhinosinusitis following a Phase II/III trial completion.
The Phase II/III trial’s (NCT05248997) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 17 May with GlobalData evaluating the product on 21 May.
The Phase III, double-blind, randomised, placebo-controlled study evaluated the safety and efficacy of the drug for the acute treatment of chronic rhinosinusitis (CRS) with or without nasal polyps. Pfizer recruited 261 patients to assess the efficacy of Nurtec (ODT) compared with placebo as its primary endpoint.
Nurtec is a calcitonin gene-related peptide (CGRP) antagonist that acts by inhibiting CGPR synthesis. The FDA approved the therapy for the acute treatment of migraines in adults in February 2020. Following this, the agency approved the drug as a preventative migraine treatment in May 2021.
LoA is determined using a combination of machine learning and GlobalData’s proprietary algorithm. It can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.
Phase II trial of tenosynovial giant cell tumour candidate terminated
AmMax Bio’s AMB-051 saw its Phase Transition Success Rate (PTSR) decrease in tenosynovial giant cell tumours after a Phase II trial was terminated. The PTSR dropped by ten points to 44%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The Phase II trial’s (NCT04938180) status was updated from completed to terminated on ClinicalTrials.gov on 24 May, and GlobalData evaluated the asset on the following day.
According to the study’s ClinicalTrials.gov listing, the study was terminated due to the sponsor stopping further recruitment in this intravenous study to focus on intra-articular route of administration.
The purpose of the open-label, multiple-dose, dose escalation study was to evaluate the intravenous dose of AMB-051. The study enrolled four patients.
MB-051 acts by inhibiting the c-fms (colony stimulating factor 1 receptor or CSF1-R) and decreases tumour associated macrophage (TAM) function and is under development for the treatment of various solid tumours.
Investigator-led Phase I/II trial for ischaemic stroke terminated
SignalChem Lifesciences’s SLC-0111 has seen its PTSR drop after an investigator-led Phase I/II trial of the candidate in acute ischaemic stroke was terminated.
The PTSR for SLC-0111 dropped in acute ischaemic stroke by 18 points to 15%.
The status of the trial which was being run by British Columbia Cancer Agency was changed from active, not recruiting to terminated on ClinicalTrials.gov on 24 May. GlobalData evaluated the asset on 27 May.
The ClinicalTrials.gov listing says the trial was terminated because the availability of nab-paclitaxel with gemcitabine in the second-line setting has changed the feasibility of further recruitment and potential long-term development opportunities of SLC-0111 with gemcitabine alone.
The Phase I/II trial (NCT03450018) was an open-label, multi-centre study that investigated oral SLC-0111 in combination with intravenous gemcitabine. There were only six patients out of the 30 originally anticipated to enrol.
SLC-0111 acts as a carbonic anhydrase IX inhibitor. The drug was under development for the treatment of solid tumours, breast cancer, recurrent glioblastoma multiforme (GBM), and metastatic pancreatic ductal adenocarcinoma.
BMS Phase I solid tumour trial completion
Bristol Myers Squibb’s BMS-986301 saw its PTSR increase following a Phase I trial completion in advanced solid cancers.
The drug’s PTSR rose by six points to 62% in renal cell carcinoma. Additionally, the PTSR increased by seven points to 63% in head and neck squamous cell carcinoma (HNSCC), 62% in melanoma, 39% in solid tumours and 67% in transitional cell carcinoma (urothelial cell carcinoma).
The trial’s status was updated on its ClinicalTrials.gov from ongoing, not recruiting to completed on 20 May and GlobalData evaluated the asset on the next day.
The Phase I trial (NCT03956680) evaluated the efficacy, safety and tolerability of BMS-986301 alone or combined with BMS’s Opdivo (nivolumab) and Yervoy (ipilimumab) in participants with cancers that failed to respond to T cell checkpoint inhibitors.
The study originally aimed to recruit 190 participants but ended up enrolling only 54 subjects. The trial’s co-primary endpoints evaluated the incidence of adverse events and deaths for a time period of up to two years, among others.
The asset is a stimulator of interferon genes protein (STING) activator. The drug acts by activating the STING pathway leading to an effector T cell response in the tumour microenvironment and in turn promoting an anti-tumour immune effect.
Phase I solid tumour trial terminated
ABM Therapeutics’s ABM-1310 saw its Phase Transition Success Rate (PTSR) decline following a Phase I trial termination in advanced solid tumours. The drug’s PTSR decreased by 35 points to 34% in melanoma, and by 11 points to 60% in glioblastoma multiforme (GBM).
The Phase I trial’s status was updated on ClinicalTrials.gov from ongoing, not recruiting to terminated on 22 May and GlobalData evaluated the asset on the same day. The study’s termination was not related to safety concerns, or lack of efficacy, according to the trial’s ClinicalTrials.gov listing.
ABM Therapeutics is a private drug discovery and development company headquartered in Pudong, Shanghai, China.
The Phase I trial (NCT04190628) evaluated ABM-1310 in adult patients with locally advanced or metastatic solid tumours and no other effective standard treatment options available, as monotherapy in patients with documented BRAF V600 mutation, or in combination with Roche’s Cotellic (cobimetinib fumarate) in adult patients who have a documented BRAF mutation and progressive disease or intolerance to at least one prior line of systemic therapy.
The study anticipated to recruit 112 participants but ended up enrolling only 53 subjects. The study’s co-primary endpoints assessed the maximum tolerated dose (MTD) and recommended Phase II dose, and included safety and pharmacokinetic values.
The asset is a serine/threonine protein kinase B-Raf inhibitor which acts by blocking B-Raf kinase. The drug candidate selectively binds to and inhibits the activity of B-Raf, which in turn inhibits the proliferation of tumour cells and elicits antineoplastic activity.
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[Link src="https://www.clinicaltrialsarena.com/features/pipeline-moves-aml-trial-fails-endpoints/" title="Pipeline Moves: Phase III AML trial fails to meet primary endpoint" font-size="20px"]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 datapoints from individual drugs, clinical trials, regulatory milestones, company, and financial databases.
