Janssen Pharmaceutical of Johnson & Johnson made a strategic call to halt development of pimodivir, an antiviral treatment for influenza A. The decision was based on data from a pre-planned interim analysis of the Phase III trial of pimodivir in hospitalized influenza A patients. The analysis suggested that the drug in combination with standard of care (SOC) was “very unlikely” to show added benefit in the patient population over SOC alone.
As such, the study in hospitalized patients with influenza A and a parallel Phase III trial of the drug in outpatients with influenza A will be halted.
Way back in June 2017, Janssen announced results of the Phase IIb Topaz Trial that showed treatment with pimodivir significantly decreased viral load over seven days compared to placebo in adults with acute, uncomplicated seasonal flu A. Patients treated with pimodivir and oseltamivir (Tamiflu) also demonstrated a significantly lower viral load compared to patients who received only pimodivir.
Janssen licensed pimodivir in 2014 from Vertex Pharmaceuticals for an upfront fee of $30 million and undisclosed milestone payments. The drug represented a new class of antiviral drugs for influenza.
“While our goal was to develop an innovative new treatment option for patients at risk of respiratory infections, unfortunately these data show that pimodivir does not offer a benefit above the existing standard of care,” said James Merson, Global Therapeutic Area Head for Infectious Diseases at Janssen. “At Janssen, we have a deep heritage of caring for those affected by respiratory infectious diseases and will continue to do so, focusing on clinical development programs that we believe will offer transformational medical innovation to patients.”
The Phase III pimodivir program evaluated the safety and efficacy of the drug in two Phase III trials with SOC in hospitalized adolescent, adult and elderly patients with flu A and in non-hospitalized adolescent, adult, and elderly patients with flu A who are at risk of developing complications.
The decision to halt the program was made in consultation with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. BARDA co-funded the program.
In the area of viruses, J&J is continuing work on its experimental COVID-19 vaccine candidate. On July 30, the company announced the vaccine had generated neutralizing antibodies in preclinical studies. That came only days after it initiated a Phase I/IIa trial of the candidate, Ad26.COV2.S.
The preclinical data demonstrated the vaccine protected against infection with SARS-CoV-2 and elicited a robust immune response, successfully preventing infection and providing complete or near-complete protection in the lungs of non-human primates.
The vaccine was designed using the AdVac recombinant technology, which is in use by Janssen. The technology as well as the PER.C6 technology has been used to develop and manufacture the company’s Ebola vaccine and its vaccine candidates for Zika, RSV, and HIV.
The vaccine program has received $1 billion in support from BARDA. The preclinical work was conducted by investigators from Beth Israel Deaconness Medical Center (BIDMC) in collaboration with Janssen.
Earlier in July, J&J entered a five-year manufacturing deal with Emergent BioSolutions. Emergent will handle contract development and manufacturing, with a goal of supplying more than one billion doses of the COVID-19 vaccine globally during 2021, assuming it is proven to be safe and effective.