This week on Pipeline Moves, we kickoff by looking at the the suspension of a Phase Ib trial in refractory acute myeloid leukaemia. We also investigate the resumption of a previously suspended Phase Ib trial in pancreatic ductal adenocarcinoma. To conclude, we examine trial completion in Prader-Willi Syndrome.

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Phase I trial suspension

Karyopharm Therapeutics’ padnarsertib saw its PTSR drop by 24 points to 25% in refractory acute myeloid leukaemia (AML) after an investigator-led Phase I trial was suspended.

The reason for suspending the open label study (NCT05394558) was not disclosed, according to the trial registry. GlobalData evaluated the asset on 7 August, after a update on 4 August. The trial was sponsored by the University of Colorado, Denver.

The Phase I trial intended to evaluate the safety and tolerability of padnarsertib for the treatment of patients with relapsed or refractory acute myeloid leukaemia. The trial enrolled 40 participants before it was suspended.

Padnarsertib inhibits PAK4 and NAMPT. The drug candidate is under development for the treatment of advanced solid malignancies including non-small cell lung cancer, relapsed or refractory AML, and non-Hodgkin’s lymphoma.

Resumption of Phase Ib trial

SignalChem’s SLC-0111 saw its PTSR increase in pancreatic ductal adenocarcinoma after a suspended investigator-led Phase Ib resumed. The PTSR jumped by 18 points to 33%.

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The Phase Ib trial (NCT03450018) was suspended on 23 June, 2022, due to restructuring at the pharmaceutical partner, according to the trial registry. The trial is sponsored by British Columbia Cancer Agency.

GlobalData evaluated the asset on 7 August, after its status was updated to recruiting on on 4 August.

The two-part Phase Ib trial is investigating SLC-0111 in combination with chemotherapy gemcitabine. The trial anticipates enrolling 30 patients with metastatic pancreatic ductal adenocarcinoma positive for carbonic anhydrase IX.

Completion of Phase I trial

ConSynance Therapeutics’ CSTI-500 saw its PTSR rise in Prader-Willi Syndrome (PWS) after a Phase I trial completion. The PTSR rose by 14 points settling at 77%.

On 9 August, the study’s (NCT05504395) status on changed from recruiting to completed. The purpose of the open-label, single centre trial was to evaluate the pharmacokinetics and safety of a 10mg single dose of CSTI-500 in subjects aged between 13 and 50 years with a genetically confirmed diagnosis of PWS.

A total of 10 patients were enrolled in the study, with their maximum observed plasma concentrations measured pre-dose and at intervals from 1-hour post-dose up to 144 hours. CSTI-500 is an orally administered triple monamine reuptake inhibitor targeting norepinephrine, serotonin, and dopamine. This increases extracellular concentrations of the neurotransmitters.

Read the last edition:

Pipeline Moves: Advancement prospects plunge for oesophageal adenocarcinoma therapy

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.

Correction: An earlier version of this article had a section on an Aura Biosciences trial, which was deleted given the correct Phase of the trial in question, on 22 August 2023.