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April 12, 2022

Pipeline Moves: Terminations of fatty liver, blood cancer, ophthalmology clinical trials cause further study chances to nosedive

Bristol Myers Squibb, GT Biopharma, and Gemini Therapeutics terminate early-phase trials of their respective assets.

By Urtė Fultinavičiūtė and William Newton

For this week’s Pipeline Moves, the Clinical Trials Arena team looks at updates in five different studies across multiple indications.

This edition starts with Bristol Myers Squibb (BMS) terminating a Phase Ib study in nonalcoholic fatty liver disease (NAFLD). We continue with GT Biopharma’s termination of a Phase I/II study impacting its asset’s progression chances in four different indications, including in systemic mastocytosis and relapsed acute myeloid leukaemia. Moving on, we look at Gemini Therapeutics ending its Phase IIa trial in geographic atrophy. Finally, we look at two investigator-led trials of assets by Partner Therapeutics and Eisai.

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BMS halts NAFLD study

BMS’ BMS-963272 saw its Phase Transition Success Rate (PTSR) for NAFLD plunge 33 points to 27% after a Phase Ib trial was terminated. The trial’s ClinicalTrials.gov page states the trial was terminated due to a change to the company’s business objectives. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase Ib’s (NCT04766476) ClinicalTrials.gov listing was updated on 31 March, and the PTSR change took effect the next day. The study had a target enrolment of 60 subjects, but it enrolled nine prior to the study’s termination. The trial recruited its first patient on 24 February 2021.

BMS-963272 is an oral medication with an undisclosed mechanism of action. The Phase Ib had 15 primary endpoints, including ones looking into adverse events and its pharmacokinetic properties.

GT cancels multi-indication Phase I/II trial

GT Biopharma’s blood cancer asset tri-specific killer engager (TriKE) GTB-3550 saw its PTSR dropping in multiple indications after a Phase I/II study was terminated. The asset’s development was halted due to the company’s development of its second-generation TriKE asset GTB-3650.

The PTSR decreased by 24 points to 23% in systemic mastocytosis, 20 points to 17% in myelodysplastic syndrome, 25 points to 31% in mast cell leukemia, and 19 points to 17% in relapsed acute myeloid leukemia. GlobalData appraised the asset on the 5 April after a ClinicalTrials.gov update on 1 April.

The open label Phase I/II (NCT03214666) enrolled 12 patients with high-risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. GTB-3550 is designed to induce natural killer cell function by targeting malignant cells and generate an anti-CD33+ tumour response.

Gemini terminates geographic atrophy trial

Gemini’s GEM103 saw a decline in its PTSR in in geographic atrophy (GA) after a Phase IIa trial was terminated as it did not offer “further benefit”. The PTSR decreased by 24 points to 21%. GlobalData appraised the asset on 5 April after a ClinicalTrials.gov update on 4 April.

The open-label study (NCT04643886) enrolled 62 patients with GA secondary to dry age-related macular degeneration (dry AMD). The trial investigated the safety of intravitreal injections of GEM103 over an 18-month timeframe. The research was done in subjects who participated in the Phase I study, as well as treatment-naïve subjects who met all eligibility criteria.

GEM103 is an intravitreal recombinant form of the human complement factor H protein (CFH), which targets the complement factor. By doing so, the asset is said to complement hyperactivity and overall dysregulation, which restores retinal health in AMD patients.

Phase II Alzheimer’s disease trial starts recruitment

Partner Therapeutics’ Leukine (sargramostim) saw its PTSR in Alzheimer’s disease hop nine points to 33% after an investigator-led Phase II trial started recruiting. ClinicalTrials.gov updated the trial’s status to recruiting on 1 April, and the PTSR change took effect on 4 April. The study is sponsored by the University of Colorado, Denver.

The Phase II trial (NCT04902703) is anticipated to recruit 42 patients with mild-to-moderate Alzheimer’s disease who will be treated with Leukine administered five days per week over 24 weeks. As a primary endpoint, the study measures the incidence of adverse events.

Leukine is a recombinant granulocyte macrophage-colony stimulating factor. The drug has FDA approval for neutropenia and radiation-induced myelosuppression, and it is also under investigation in Parkinson’s disease and Crohn’s disease.

Investigator-led peritoneal cancer trial completes

Eisai’s Lenvima (lenvatinib mesylate) saw its PTSR in peritoneal cancer grow after the completion of an investigator-sponsored Phase I trial. The PTSR increased by seven points, reaching 73%. The study was completed on 7 April and GlobalData reported its PTSR change on 8 April.

The Phase I open-label study (NCT02788708) investigated the safety and efficacy of different doses of Lenvima in combination with weekly chemotherapy paclitaxel in 26 patients with recurrent ovarian or endometrial cancer, fallopian tube carcinoma, or primary peritoneal carcinoma.

Ohio State University Comprehensive Cancer Center is the trial sponsor. Lenvima is approved for thyroid cancer and renal cell carcinoma.

Additional writing by Clinical Trials Arena healthcare researcher Irena Maragkou

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.

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