Release Date: November 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Acelyrin Inc (SLRN, Financial) has strategically refocused its pipeline to prioritize the development of its lead product candidate, Magua map, for thyroid eye disease (TED).
- The company has shown positive proof of concept data for Magua map, demonstrating rapid improvements in proptosis and clinical activity scores within three weeks.
- Acelyrin Inc (SLRN) has completed a positive end of phase two meeting with the FDA, achieving alignment on important elements of the phase three registrational program.
- The company has resolved outstanding manufacturing commitments, transforming a significant contractual liability into a net expense of only $7.2 million.
- Acelyrin Inc (SLRN) maintains a strong financial position with $562.4 million in cash, providing operational runway to at least mid-2027.
Negative Points
- The company has not yet fully enrolled cohort four in its phase two trial, which may delay the announcement of full results and detailed phase three program design.
- There is uncertainty regarding the future development plans for uveitis, as decisions will be made after reviewing upcoming data.
- The company has not provided specific guidance on the timing of the phase three trials for both active and inactive TED populations.
- Acelyrin Inc (SLRN) has not announced the pivotal dose for the phase three trial of Magua map, leaving some uncertainty about the final dosing strategy.
- The potential market impact of Humira biosimilars could affect the attractiveness of further developing Isobe for uveitis if the data does not show superiority.
Q & A Highlights
Q: Can you help us better understand what data the FDA saw during the end of phase two meeting? Was it just data from the first three cohorts or did they see partial data from cohort four? And is it fair to say that the pivotal TED trial will likely include a dose somewhere in the 70 to 100 mg range being tested in cohort four?
A: We showed the FDA data from the first three cohorts, which tested doses from 25 to 100 mg with regimens ranging from weekly to monthly. The 70 to 100 mg range in cohort four is being used primarily to confirm a loading dose, aiming for faster patient benefit. The pivotal dose will be announced when we release the data and provide details on the phase three program. - Mina Kim, CEO
Q: What gives you confidence that ISOBE is Cmax driven? If the molar exposure at 160 mg subcutaneous comes slightly lower than 10 mg/kg IV, will that be enough to bring a significant clinical benefit?
A: We have done extensive work on ISOBE's potency, showing that 160 mg subcutaneous weekly is equipotent to 10 mg/kg IV of secukinumab. ISOBE's smaller size allows it to penetrate the blood-retinal barrier, potentially offering dual abrogation of inflammation both systemically and locally, which could lead to improved outcomes. - Shepton PFU, Chief Medical Officer
Q: Given the base case for the phase three study in uveitis, what would the capital commitment look like? How soon would you be able to kick off a pivotal study following top line data in December?
A: We have significant flexibility within our runway to further develop ISOBE if the data supports it. While we haven't provided specific timing guidance, we know the program well and will update on timing after reviewing the data and consulting with the FDA. - Gil Labrucherie, CFO
Q: Can you remind us what constitutes a clinically meaningful benefit in the uveitis patient population? How are you currently thinking about the market opportunity given the entry of Humira biosimilars?
A: There is a high unmet need in uveitis, with steroids and Adalimumab being the main treatments. We aim for a superior clinical profile compared to Adalimumab. The market opportunity is significant, especially within the orphan pricing framework, given the unmet need. - Mina Kim, CEO
Q: For the next data cut and eventual pivotal data, what would you consider a clinically meaningful hearing impairment benefit versus Tepezza?
A: We are calibrating doses to mitigate overexposure associated with hearing impairment. We will share our approach to hearing assessments and expectations at our investor event in early 2025. It's important to consider that 40-50% of thyroid eye disease patients have hearing issues, so outcomes will be explored based on these considerations. - Shepton PFU, Chief Medical Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
