Silence Therapeutics Plc American Depository Share Study result
Review the key takeaways and the transcript of this earnings call.
- Silence Therapeutics announced positive top line results from the phase two Sanriku trial evaluating Davison, a first-in-class siRNA therapy for polycythemia vera (PV).
- The study met its primary endpoint with 88% of treated patients maintaining hematocrit below 45% without the need for phlebotomy versus 18% on placebo, a nearly 70% placebo-adjusted difference (p<0.0001).
- Both every six week (Q6W) and every 12 week (Q12W) dosing intervals showed strong response rates over 80% and 90%, respectively.
- Davison was well tolerated with no major safety concerns; injection site reactions were infrequent and self-limiting, and only two grade one anemia adverse events were reported in the Q6W arm.
- The mean number of phlebotomies was 0.2 in the combined treatment arms versus 2.1 in placebo, with over 90% of treated patients requiring no phlebotomies compared to 12.5% on placebo.
- The trial enrolled 48 phlebotomy-dependent patients across nine countries and four continents, with patients allowed stable background cytoreductive therapy.
- Secondary outcomes included improvements in hematocrit control, iron metabolism markers, and patient-reported quality of life measures.
- The company plans to present more detailed data at upcoming research conferences and has submitted an abstract to ASH for December.
- An end of phase two meeting with the FDA is planned by year-end, with initiation of a phase three registration trial expected in the first half of 2027.
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Transcript
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Good morning. I would like to welcome you to the Silence Therapeutics conference call to discuss top-line results from the Phase II SANRECO study. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session where you will have the opportunity to ask questions. Thank you. I would now like to turn the call over to Gem Hopkins, Vice President and Head of Investor Relations and Corporate Communications.
Thank you, Heidi, and thanks everyone for joining us. With me today are Iain Ross, our Chairman and Interim Principal Executive Officer, who will provide some opening comments, and Steven Romano, our Chief R&D Officer, who will review the SANRECO study and top-line results. We will then open the call to your questions. Rhonda Hellums, our Chief Financial Officer, is also joining us on the line and available for questions. Today's press release and presentation are available on our corporate website at silence-therapeutics.com/events. Before we begin, I would like to remind you that this call will contain remarks concerning Silence's future expectations, clinical development plans and prospects, which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995.
Factors that could cause these results to differ materially are described in today's press release, as well as our filings with the SEC. Any forward-looking statements that we make on this call are based on assumptions as of today, and we undertake no obligation to update these statements as a result of new information or future events. With that, I'd like to turn the call over to Iain.
Iain? Thank you, Gem, and good morning and good afternoon, everyone.
Earlier this morning, we issued a press release announcing positive top-line results for our Phase II SANRECO trial evaluating divesiran, a first-in-class siRNA therapy in patients with polycythemia vera or PV. Let me be clear, this is the big win scenario. We are absolutely thrilled with these results and what they could mean for patients, physicians, families, and the broader PV community. This is also an important milestone for Silence. Turning to slide four, Silence is a platform company that has pioneered siRNA research for over two decades. The PV results we are sharing today highlight the key strengths of the siRNA approach, high potency, durable effect, specificity, favorable tolerability, and the potential for infrequent dosing.
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