— Updating peak systemic mastocytosis franchise income alternative to $4 billion, catalyzed by robust AYVAKIT ® (avapritinib) launch and evolving SM prevalence estimates —
— Anticipate to attain $2 billion in AYVAKIT income by 2030 —
— BLU-808 demonstrates vast therapeutic window with speedy, strong and sustained tryptase reductions exceeding 80% in Section 1 wholesome volunteer research —
— Kate Haviland, CEO, to current at J.P. Morgan convention on Monday, January 13 at 9:00 a.m. PT (12:00 p.m. ET) —
“With AYVAKIT growing towards a multibillion-dollar opportunity, anchoring our SM franchise, and with BLU-808, our next program with blockbuster potential coming into focus, we enter 2025 in the strongest position we have ever been in as a company. We have a number of commercial and clinical catalysts that we expect to deliver significant near- and long-term value to both patients and shareholders,” mentioned Kate Haviland, Chief Govt Officer of Blueprint Medicines. “Driven by scalable innovation and operational excellence, we aspire to fundamentally shift the way many allergic and inflammatory diseases are treated by targeting the mast cell. We have built a high-performing commercial engine that enables a truly integrated approach from research to development to commercialization, allowing us to realize operational efficiencies and resulting in a durable financial profile.”
Systemic Mastocytosis (SM): A Giant and Rising Alternative (SO:)
Primarily based on the power of the worldwide AYVAKIT launch thus far, vital sustained progress in identified SM sufferers, and new epidemiology knowledge suggesting SM prevalence is larger than beforehand thought, Blueprint now estimates the height income alternative for the corporate’s SM franchise is $4 billion, with $2 billion in annual revenues anticipated to be achieved by AYVAKIT by 2030.
Blueprint plans to report monetary outcomes for the fourth quarter and full-year 2024 in February 2025. The corporate beforehand offered steering in October 2024 for AYVAKIT product income of $475 to $480 million for full-year 2024, representing a rise of greater than 130 p.c over 2023.
Optimistic Information from BLU-808 Wholesome Volunteer Trial
Blueprint at this time introduced outcomes from the Section 1 single-ascending dose (SAD; n=56) and multiple-ascending dose (MAD; n=31, 14-day dosing) trial of BLU-808, a extremely potent and selective oral wild sort KIT inhibitor, in wholesome volunteers. Detailed knowledge can be offered on the J.P. Morgan convention.
Security: BLU-808 was well-tolerated in any respect doses examined. All treatment-emergent hostile occasions (AEs) within the MAD cohorts [1-12 mg once daily (QD)] in those that obtained BLU-808 have been Grade 1. There have been no critical AEs, no discontinuations or dose modifications resulting from AEs, and no vital modifications in laboratory measures.
Pharmacokinetics: BLU-808 confirmed a half-life of roughly 40 hours, enabling once-daily dosing, and constant, dose-dependent will increase in drug publicity. Within the MAD cohorts, all BLU-808 doses led to sustained goal protection, with imply plasma concentrations exceeding predicted KIT IC50 ranges at ‰¥1 mg QD and IC90 ranges at ‰¥3 mg QD.
Pharmacodynamics: BLU-808 confirmed dose-dependent serum tryptase responses, reflecting proof of mast cell goal engagement throughout a number of dose ranges. Within the SAD cohorts, reductions in tryptase have been noticed after a single dose of BLU-808. Within the MAD cohorts, speedy, strong and sustained reductions in tryptase have been noticed, with reductions under the decrease restrict of quantification (LLOQ) at a number of dose ranges.
Change in Serum Tryptase (MAD)
Dose
Tryptase discount at Day 15
Contributors reaching LLOQ
Placebo (n=8)
-4 %
0
1 mg (n=6)
-23 %
1/6
3 mg (n=6)
-41 %
1/6
6 mg (n=6)
-66 %
3/6
12 mg (n=4) a
-87 %
3/4
a One participant within the 12 mg cohort had undetectable tryptase ranges at baseline and was not included within the tryptase evaluation.
“These Phase 1 data support the best-in-class potential of BLU-808, which was designed to achieve unique potency and selectivity enabling a tunable treatment approach and optimization of benefit-risk across a diverse set of mast cell-driven diseases,” mentioned Percy Carter, Ph.D., Chief Scientific Officer at Blueprint Medicines. “The results show that BLU-808 performed consistently, with dose-dependent outcomes, including rapid, robust and sustained reductions in serum tryptase across a range of doses, which reinforce the potential for tunable treatment. Based on these positive data, we are initiating proof-of-concept studies in chronic urticaria, allergic asthma, allergic rhinitis, allergic conjunctivitis and mast cell activation syndrome to characterize BLU-808’s broad therapeutic potential across multiple diseases where mast cells play a core role in the disease biology.”
Extra Pipeline Updates
Blueprint continues to judge applications throughout the corporate’s numerous pipeline and prioritize investments in probably the most compelling applications with first- or best-in-class potential. Blueprint at this time introduced the next updates:
With a spotlight driving continued innovation and lengthening the longer-term lifecycle of the corporate’s SM franchise, Blueprint has initiated the registration-enabling Section 3 HARBOR trial of elenestinib, a next-generation KIT D816V inhibitor, in sufferers with indolent systemic mastocytosis (ISM).Blueprint is advancing CDK2 and CDK4 focused protein degraders, which have progressed sooner than anticipated in preclinical improvement towards probably best-in-class profiles and is prioritizing additional funding in its CDK franchise for breast most cancers and different strong tumors to those applications. Blueprint is finishing the Section 1 dose escalation research of its CDK2 inhibitor BLU-222 and plans to de-prioritize additional funding on this program. The corporate continues to have interaction strategic companions on potential alternatives to broadly advance its franchise of CDK applications.
2025 Company Targets
Develop franchise management in SM
Ship continued robust and regular AYVAKIT income progress in 2025Present further long-term knowledge from the PIONEER trial of AYVAKIT in ISM within the first half of 2025Achieve reimbursement of AYVAKYT in ‰¥20 nations general by the tip of 2025Activate websites and drive affected person enrollment of the Section 3 HARBOR trial of elenestinib in ISM all through 2025
Obtain BLU-808 medical proof-of-concept in allergic and inflammatory illnesses
Current topline outcomes from the Section 1 wholesome volunteer trial on the J.P. Morgan convention on January 13, 2025Initiate proof-of-concept trials in persistent spontaneous urticaria, persistent inducible urticaria, allergic rhinitis and allergic conjunctivitis within the first half of 2025Initiate proof-of-concept trials in allergic bronchial asthma and mast cell activation syndrome within the second half of 2025
Drive analysis innovation in allergy/irritation and oncology/hematology
Nominate two improvement candidates, together with the corporate’s first focused protein degrader, within the second half of 2025
J.P. Morgan Healthcare Convention Presentation Data
Kate Haviland, Chief Govt Officer of Blueprint Medicines, will current an organization overview and 2025 outlook on the forty third Annual J.P. Morgan Healthcare Convention on Monday, January 13 at 9:00 a.m. PT (12:00 p.m. ET). A reside webcast of the presentation and Q&A session can be obtainable by visiting the “Events and Presentations” part of Blueprint Medicines’ web site at http://ir.blueprintmedicines.com. A replay of the webcast can be archived on Blueprint Medicines’ web site for 30 days following the presentation.
About Blueprint Medicines
Cautionary Be aware Relating to Ahead-Trying Statements
This press launch comprises forward-looking statements throughout the which means of the Personal Securities Litigation Reform Act of 1995, as amended, together with, with out limitation, statements concerning Blueprint Medicines’ views with respect to the height systemic mastocytosis franchise and AYVAKIT income alternatives; the continued progress of the AYVAKIT launch within the U.S. and in different nations; the enlargement of Blueprint Medicines’ mast cell illness franchise with the event of elenestinib and BLU-808; the development of BLU-808 and focused protein degrader analysis applications for CDK2; the potential for BLU-808 to handle allergic and inflammatory illnesses; plans to proceed the Section 3 portion of the HARBOR trial of elenestinib; plans, methods, timelines, expectations and potential advantages for Blueprint Medicines’ present or future authorised medication and drug candidates and in treating sufferers; and Blueprint Medicines’ monetary efficiency, technique, together with the prioritization of its capital sources, objectives and anticipated 2025 company milestones, enterprise plans, outlook and focus. The phrases “aim,” “goals” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and comparable expressions are supposed to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to quite a lot of dangers, uncertainties and essential components which will trigger precise occasions or outcomes to vary materially from these expressed or implied by any forward-looking statements contained on this press launch, together with, the chance that the market alternatives for systemic mastocytosis, together with AYVAKIT (avapritinib), or different Blueprint Medicines drug candidates are smaller than the corporate estimates or that any approval it obtains could also be based mostly on a narrower definition of the affected person inhabitants than it anticipates; the advertising and sale of AYVAKIT (avapritinib) or any future authorised medication could also be unsuccessful or much less profitable than anticipated, or that AYVAKIT (avapritinib) could not achieve market acceptance by physicians, sufferers, third-party payors and others within the medical neighborhood; the chance of delay of any present or deliberate medical trials or the event of Blueprint Medicines’ present or future drug candidates; dangers associated to Blueprint Medicines’ skill to efficiently show the protection and efficacy of its drug candidates and achieve approval of its drug candidates on a well timed foundation, if in any respect; preclinical and medical outcomes for Blueprint Medicines’ drug candidates could not help additional improvement of such drug candidates both as monotherapies or together with different brokers or could affect the anticipated timing of information or regulatory submissions; the timing of the initiation of medical trials and trial cohorts at medical trial websites and affected person enrollment charges could also be delayed or slower than anticipated; actions of regulatory companies could have an effect on its authorised medication or its present or future drug candidates, together with affecting the initiation, timing and progress of medical trials; dangers associated to Blueprint Medicines’ skill to acquire, preserve and implement patent and different mental property safety for its merchandise and present or future drug candidates it’s growing; the success of Blueprint Medicines’ present and future collaborations, financing preparations, partnerships or licensing and different preparations; dangers associated to its liquidity and monetary place, together with the chance that Blueprint Medicines could also be unable to generate enough future product revenues to attain and preserve a self-sustainable monetary profile; and the accuracy of its estimates of revenues, bills and capital necessities. These and different dangers and uncertainties are described in better element within the part entitled “Risk Factors” in Blueprint Medicines’ filings with the Securities and Trade Fee (SEC), together with Blueprint Medicines’ most up-to-date Annual Report on Kind 10-Ok, as supplemented by its most up-to-date Quarterly Report on Kind 10-Q and every other filings that Blueprint Medicines has made or could make with the SEC sooner or later. Any forward-looking statements contained on this press launch signify Blueprint Medicines’ views solely as of the date hereof and shouldn’t be relied upon as representing its views as of any subsequent date. Besides as required by legislation, Blueprint Medicines explicitly disclaims any obligation to replace any forward-looking statements.
Emblems
Blueprint Medicines, AYVAKIT, AYVAKYT and related logos are logos of Blueprint Medicines Company.
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