Allarity Therapeutics is open to CRO pitches to help run its forthcoming Phase II/III trial investigating its poly ADP-ribose polymerase (PARP) inhibitor stenoparib in hospitalised Covid-19 patients, CEO Steve Carchedi said. Decisions are to be made as soon as possible, he added. Although Allarity is ready to start the US-based trial, initiation is dependent on when it hears back from the US Biomedical Advanced Research and Development Authority (BARDA) about its funding request, Carchedi added.
Denmark-headquartered Allarity already has a couple of CROs on its shortlist, with the successful CRO likely to have worked on Covid-19 previously, Carchedi said, adding the CRO would help with trial recruitment, among other tasks. He said it is challenging to estimate a timeframe for when it will hear back from BARDA and how much funding it is likely to receive. However, a Phase II/III trial of this size would likely require around $5m–$10m to initiate and run, he noted.
The Phase II/III will recruit around 900 hospitalised patients, with these patients either receiving stenoparib with Gilead Science’s Veklury (remdesivir) or Veklury alone. A primary endpoint will investigate how much the combination improves survival outcomes, he said. The trial will also investigate how quickly the combination eliminates SARS-CoV-2 viral load, he noted. The trial will recruit adult patients, a segment for which Veklury is approved, he added. Veklury was FDA approved on 22 October in hospitalised Covid-19 patients ages 12 years and older, and is intended for use only in hospitals capable of providing acute or inpatient hospital care.
Allarity’s preclinical data show oral stenoparib has potential as an antiviral by inhibiting SARS-CoV-2 replication, both as a monotherapy and in combination with Veklury, Carchedi added. Compared to Veklury, which prevents viral replication downstream of cell entry, preclinical data show stenoparib stops the entry and post entry processes. Additionally, the combination could potentially have a synergistic effect against the virus (Stone, N., et al., MBio. 2021 Jan 19;12(1):e03495–20). Preclinical data show stenoparib may limit the expression of cytokines like interleukin (IL)-1, IL-6, and tumour necrosis factor-alpha, which are relevant in Covid-19’s cytokine storm stage, he added.
Although other PARP inhibitors are available in the market, stenoparib’s added mechanism of inhibiting the enzyme trankyrase may mean its Covid-19 data is not applicable to other PARP inhibitors, Carchedi said. Allarity is conducting additional preclinical research on stenoparib’s potential in the more transmissible SARS-CoV-2 variant B.1.1.7, to be completed at the Norther Arizona University, according to a 26 January media release.
Stenoparib is one of Allarity’s oncology assets and is currently in a Phase II trial (NCT03878849) in advanced ovarian cancer.
Reynald Castaneda is Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.