PhaseBio Pharmaceuticals has voluntarily stopped the Phase IIb clinical trial of its new therapy, pemziviptadil (PB1046) to treat pulmonary arterial hypertension (PAH) in adults.
Administered subcutaneously, pemziviptadil is a recombinant fusion protein comprised of vasoactive intestinal peptide (VIP) and elastin-like polypeptide (ELP) biopolymer of the company.
It obtained orphan drug designation from the US Food and Drug Administration to treat PAH and Duchenne Muscular Dystrophy-associated cardiomyopathy.
The move to suspend the study early comes after the Covid-19 pandemic impacted the production, related drug supply and the enrolment rate in the trial.
This trial had recruited over half its subject enrolment target.
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By GlobalDataAccording to the drug’s pharmacokinetic profile noted in trials, combining VIP with ELP offers an extended absorption profile as well as a lengthier circulation half-life, allowing once-weekly administration.
PhaseBio will evaluate the study results to identify the best course of action for the programme, which might comprise an enhanced product presentation as well as streamlined product dosage in a future trial.
With the latest development, the company will redirect resources and funds into pre-marketing activities of bentracimab and to advance other products in its pipeline, comprising PB6440 to treat resistant hypertension.
PhaseBio Pharmaceuticals CEO Jonathan Mow said: “With the continued impact of the Covid-19 pandemic on this Phase IIb clinical trial, we believe a full evaluation of the programme makes sense at this time and that any positive data generated could help galvanise support for the future development of pemziviptadil.
“Upon completion of the final analyses of the pemziviptadil trial, we will evaluate the potential for a future trial of pemziviptadil.”
In January this year, the company announced the European Union expansion of its Phase III REVERSE-IT trial of bentracimab to reverse antiplatelet effects of ticagrelor.
