Release Date: February 20, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What are your expectations for the Phase II data for brensocatib in CRS without nasal polyps, and what would be considered good data to move the opportunity forward? A: William Lewis, CEO, emphasized the potential of brensocatib in CRS without nasal polyps, noting the significant unmet medical need. Martina Flammer, CMO, explained that the BiRCh study is a proof-of-concept trial using a sinus total symptom score as the primary endpoint. They are looking for a difference as small as 0.9 in the symptom score, with the study powered at 80% to detect this change. The study includes patients already on nasal steroids, and success could validate the DPP1 mechanism for this condition.
Q: Beyond clinical data and a sales force, what other factors are you leveraging to ensure a strong launch for brensocatib in bronchiectasis? A: William Lewis, CEO, highlighted the importance of market access as a critical factor under their control. They aim for a frictionless launch by ensuring a straightforward prior authorization process and reauthorization for patients. Sara Bonstein, CFO, added that they have augmented their sales organization and are adding more field access managers to support the launch.
Q: How do you feel about the availability of FDA staff to review brensocatib on time, given potential staffing shortages? A: William Lewis, CEO, stated that their interactions with the FDA have been regular and encouraging. He noted that the staff involved in NDA reviews are funded by PDUFA fees, which should protect them from broader government staffing issues. The priority review granted by the FDA is a positive sign.
Q: Can you remind us of your estimate of how many US bronchiectasis patients have had two or more exacerbations in the past year? A: William Lewis, CEO, estimated that about 50% of the 500,000 diagnosed bronchiectasis patients in the US have had two or more exacerbations in the last year. He noted that this is just the beginning of the potential addressable market, as many patients with comorbid conditions like COPD and asthma could also benefit from treatment.
Q: What are your expectations for the upcoming TPIP data, particularly regarding PVR reductions and the Phase III PH-ILD study? A: William Lewis, CEO, explained that PVR reductions in the low to mid-20s would position TPIP as best-in-class among prostacyclins. The Phase III PH-ILD study is progressing, with the final trial design focusing on single capsule administration for every dose strength. They are also considering insights from the PAH data to inform the Phase III protocol.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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