Pfizer incurs $230M loss after scrapping DMD gene therapy and RSV combo vaccine

Pfizer has decided to terminate its troubled Duchenne muscular dystrophy (DMD) gene therapy program after a phase 3 clinical trial failure. This decision has resulted in a significant financial impact of $230 million on the company's second quarter results. The pharmaceutical giant announced this move alongside the discontinuation of a phase 2 respiratory syncytial virus (RSV) combination vaccine.

The phase 3 trial for the DMD gene therapy, known as fordadistrogene movaparvovec, failed in June, leading Pfizer to reassess its options. Six weeks later, the company confirmed that it would no longer pursue this candidate, officially removing it from their pipeline and recording a $230 million charge. This marks the end of a problematic program that faced multiple setbacks. Just a month before the phase 3 trial failure, Pfizer had paused the dosing in the crossover segment of the trial after a young boy in another study died. Additionally, the company laid off 150 workers in North Carolina due to the program's failure.

Sarepta Therapeutics, another player in the DMD gene therapy field, has also faced challenges. Its DMD gene therapy, Elevidys, did not meet the primary endpoint in a pivotal study. Despite this, Sarepta has continued to push forward, expanding Elevidys' label and striving to reach more patients.

Pfizer’s discontinuation of the DMD gene therapy was disclosed along with the cessation of work on a phase 2 respiratory vaccine combination. The candidate, identified as PF-07960613, was designed to combine vaccines against RSV and COVID-19. Although no candidate by this specific name is listed on ClinicalTrials.gov, the database includes information about a Pfizer phase 2 trial for a combination vaccine targeting RSV and COVID-19. This study, conducted from June 2023 to early 2024, involved more than 1,000 participants aged 65 and above. They received various vaccine regimens, including a combination of Pfizer's RSVpreF and the bivalent COVID-19 vaccine BNT162b2, along with a quadrivalent influenza shot.

RSVpreF is Pfizer's RSV protein subunit vaccine, marketed as Abrysvo, while the bivalent BNT162b2 is an updated version of Pfizer’s COVID-19 vaccine, Comirnaty. The study evaluated the safety profile of the vaccine combinations, focusing on local reactions, systemic events, and adverse events. Pfizer also examined the immune responses elicited by the different vaccine regimens.

This decision to halt both the DMD gene therapy and the RSV combination vaccine highlights Pfizer's ongoing efforts to streamline its pipeline and focus on more promising candidates. The substantial financial write-off and workforce reduction underscore the challenges faced in the field of gene therapy and vaccine development.

In summary, Pfizer's discontinuation of the DMD gene therapy and the RSV combination vaccine represents a significant shift in its research and development strategy. The failure of the DMD program, coupled with the decision to halt the RSV vaccine work, reflects the difficulties and risks inherent in pharmaceutical innovation. Despite these setbacks, Pfizer remains committed to advancing its pipeline and delivering effective treatments to patients.

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