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February 15, 2022

Pipeline Moves: Pfizer’s hidradenitis suppurativa Phase II completion boosts further study chances

The Clinical Trials Arena team also reviews trial completions in pneumonia and cancer, as well as the likelihood of approval of one rare disease asset.

By Clinical Trials Arena Team

In this week’s edition of Pipeline Moves, we look into the Phase Transition Success Rate (PTSR) of four different assets in hidradenitis suppurativa, pneumonia, and cancer. We also dive into the Likelihood of Approval (LoA) of Pharming’s PI3K-delta inhibitor in two rare disease indications.

PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm.

Sign up to our weekly Pipeline Moves newsletter here. You can read last week’s edition here.

Pfizer completes hidradenitis suppurativa trial

Pfizer’s PF-06650833 (zimlovisertib) for hidradenitis suppurativa saw its PTSR rise nine points to 33% after its Phase II trial was completed. Its ClinicalTrials.gov page was updated to “completed” on 4 February, and the PTSR change took effect 7 February.

The placebo-controlled Phase II (NCT04092452) enrolled 197 patients with moderate-to-severe hidradenitis suppurativa. As a primary endpoint, the trial measured the percent of participants with clinical response (HiSCR). HiSCR is defined as more than 50% reduction in inflammatory lesion count and no increase in abscesses or draining fistulas relative to baseline.

Zimlovisertib is an interleukin-1 receptor-associated kinase 4 inhibitor. It was studied alongside Pfizer’s PF-06700841 and PF-06826647, which are also kinase inhibitors.

On 29 July, Clinical Trials Arena reported that even if AbbVie’s Humira (adalimumab) has at least a five-year market headstart, its dominance in is not set in stone. However, challengers in this disease space need to be weary of undercover competitors in the form of off-label biologics.

Plexxikon also completes oncology trial

Plexxikon’s PLX2853 had its PTSR in uveal melanoma and non-Hodgkin lymphoma bump after the completion of a Phase Ib/IIa study of subjects with advanced malignancies. The PTSR in uveal melanoma grew by seven points to 28% and by six points to 37% in non-Hodgkin lymphoma.

The 49-subject trial (NCT03297424) had its status changed to “completed” in a ClinicalTrials.gov update on 8 February. GlobalData updated its system on 10 February. The trial has a variety of primary endpoints investigating its safety, pharmacokinetics, and pharmacodynamics.

PLX2853 is an oral inhibitor of bromodomain-containing protein 4 (BRD4), resulting in the slowing of growth and proliferation of tumor cells. Plexxikon is a subsidiary of Daiichi Sankyo.

Bioversys updates Phase I trial of pneumonia asset

Bioversys’ BV100 (rifabutin) had its PTSR in ventilator-associated pneumonia (VAP) and hospital-acquired pneumonia (HAP) rise after the completion of a Phase I study in healthy subjects. The PTSR in VAP and HAP grew by seven points to 69% and 66%, respectively.

The 54-subject study (NCT04636983) had its status changed to “completed” in a ClinicalTrials.gov update on 8 February, with GlobalData appraising the asset the next day. The placebo-controlled Phase I recruited male subjects. It has a primary endpoint investigating the safety of the asset’s single intravenous ascending doses over a 10-day timeframe.

Rifabutin is an intravenous antibiotic, which is under development by the company for the treatment of infections caused by the carbapenem-resistant Acinetobacter baumanii (CRAB) bacteria in indications such as VAP or HAP.

Investigator-sponsored Phase I of Telix asset completes

Telix Pharmaceuticals’ TLX-591 saw its PTSR in ovarian cancer jump seven points to 58% after an investigator-sponsored Phase I solid tumour trial was completed. Its ClinicalTrials.gov page was updated to “completed” on 2 February, and the PTSR change took effect the following day.

The Phase I (NCT00967577) investigated TLX-591, also known as the 177Lu-J591 antibody, in 20 patients with advanced, malignant solid tumours. Weill Cornell Medical College sponsored the trial.

As coprimary endpoints, the study used dynamic contrast enhanced (DCE)-MRI examination as well as diffusion-weighted imaging (DWI) to measure change in tumour perfusion. TLX-591 is designed to deliver radiation to blood vessels that supply solid tumours, without affecting noncancerous blood vessels.

Pharming reports positive rare disease data

Pharming’s PI3K-delta inhibitor CDZ173 (leniolisib) saw its LoA rise following positive topline Phase II/III results. The LoA increased 10 points to 28% in angioimmunoblastic T-cell lymphoma (AITL), as well as rising three points to 23% in activated PI3K-delta syndrome (APDS).

Pharming published topline results in a 2 February press release, and the LoA change took effect on 4 February. LoA can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

The Phase II/III study (NCT02435173) enrolled 37 patients with genetically activated PI3K-delta. Leniolisib met its primary efficacy endpoints of reduction in lesions (p=0.0012) and normalisation of immune dysfunction (p<0.0001) compared to baseline.

Novartis discovered and developed leniolisib before licensing the asset to Pharming in 2019. Novartis also sponsored the Phase II/III registrational trial.

Pharming has said it plans to pursue regulatory filings for leniolisib’s approval for APDS in Q2 this year. APDS, also known as PASLI disease, is an ultrarare primary immunodeficiency disease characterised by sinopulmonary infections, lymphoproliferation, autoimmunity, and enteropathy.

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