Dyne Therapeutics to Host Virtual Investor Event to Review New Clinical Data from the ACHIEVE and DELIVER Trials Tomorrow, May 20 at 8:00 a.m. ET

Dyne Therapeutics to Host Virtual Investor Event to Review New Clinical Data from the ACHIEVE and DELIVER Trials Tomorrow, May 20 at 8:00 a.m. ET

Dyne Therapeutics, Inc . (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced it now plans to report new efficacy and safety data from its Phase 12 ACHIEVE and DELIVER clinical trials on May 20, 2024, and to host a virtual event at 8:00 a.m. ET. This represents an update to Dyne's prior guidance for the second half of 2024. The company intends to issue a press release prior to the start of the event.

Phase 1/2 ACHIEVE Trial of DYNE-101 in DM1

  • ACHIEVE is a Phase 1/2 global clinical trial evaluating DYNE-101 in adult patients with myotonic dystrophy type 1 (DM1) who are 18 to 49 years of age. ACHIEVE, which is designed to be a registrational trial, consists of a 24-week multiple ascending dose (MAD), randomized, placebo-controlled period, a 24-week open-label extension (OLE) and a 96-week long-term extension (LTE). Enrollment is complete through the 6.8 mg/kg (approximate ASO dose) cohort evaluating once every eight-week dosing. A total of 56 patients have been enrolled in the study with approximately 500 doses administered to date.

  • In the upcoming clinical update, Dyne plans to report safety and tolerability data from all enrolled cohorts. Additionally, pharmacokinetic and pharmacodynamic data, including change from baseline in splicing, measures of muscle strength and function, and patient reported outcomes will be shared. Efficacy data will be shared from the 1.8 mg/kg Q4W cohort (n=16) at 12 months, 3.4 mg/kg Q4W cohort (n=16) at 6 months, and 5.4 mg/kg Q8W cohort (n=8) at 3 months.

Phase 1/2 DELIVER Trial of DYNE-251 in DMD

  • DELIVER is a Phase 1/2 global clinical trial evaluating DYNE-251 in ambulant and non-ambulant males with Duchenne muscular dystrophy (DMD) who are ages 4 to 16 and have mutations amenable to exon 51 skipping. DELIVER, which is designed to be a registrational trial, consists of a 24-week MAD, randomized, placebo-controlled period, a 24-week OLE and a 96-week LTE. Enrollment is complete through the 40 mg/kg (approximate PMO dose) cohort evaluating once every eight-week dosing. A total of 48 patients have been enrolled in the study with approximately 480 doses administered to date.

  • In the upcoming clinical update, Dyne plans to report safety and tolerability data from all enrolled cohorts. Additionally, pharmacokinetic and pharmacodynamic data, including dystrophin expression measured by Western blot, will be shared from the 10 mg/kg Q4W cohort (n=8) at 6 months.

Virtual Investor Event

The live event webcast will be available on the Events & Presentations page of the Investors & Media section of Dyne's website and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit https://investors.dyne-tx.com/news-and-events/events-and-presentations .

About Dyne Therapeutics

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

Contacts:

Investors
Amy Reilly
areilly@dyne-tx.com
857-341-1203

Media
Stacy Nartker
snartker@dyne-tx.com
781-317-1938


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AbbVie Biotech Innovators Award. (CNW Group/AbbVie Canada)

"We are delighted to have this opportunity to collaborate with a global biopharmaceutical company such as AbbVie, and the University of Toronto's SpinUp, to advance Neuropeutics' therapeutic research and development across multiple neurodegenerative diseases. At Neuropeutics, we are committed to developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. This award allows us to pursue that mission with greater momentum," said Dr. Marc Shenouda , CEO & Co-Founder of Neuropeutics Inc.

Neuropeutics Inc's scientific entrepreneurial spirit directly aligns with the mandate of the AbbVie Biotech Innovators Award to foster research, innovation and growth within Canada's life sciences sector. A hallmark of neurodegenerative diseases is protein aggregation. One such protein is TDP-43, a normally nuclear DNA/RNA binding protein, which in disease conditions becomes mislocalized and forms cytoplasmic aggregates causing neuronal toxicity. Neuropeutics Inc has developed a novel strategy to address diseases such as: Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Alzheimer's disease, Huntington's disease and Parkinson's disease.

"It was impressive and motivating to see the variety of entries and the calibre of early-stage biotech companies who applied for the Award. We thank all who participated in this life science competition," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "After a rigorous evaluation process, it is with great pleasure that we are announcing that Neuropeutics has been named the recipient of the AbbVie Biotech Innovators Award for its pioneering work in neurodegenerative diseases. We look forward to supporting the journey of Neuropeutics, in collaboration with SpinUp, to accelerate their efforts to deliver life-changing innovation to patients."

"Congratulations to Neuropeutics on being the first AbbVie Biotech Innovators Award recipient, and welcome to SpinUp – the University of Toronto's wet lab incubator," said France Gagnon , Vice-Principal, Research and Innovation at the University of Toronto Mississauga. "This is the place where the potential of Neuropeutics' work in neurodegenerative diseases can be realized and the impact on life sciences can be game changing. We are pleased to collaborate with AbbVie, a global leader in the biopharmaceutical industry, to offer this unique opportunity to this competitively chosen startup."

The AbbVie Biotech Innovators Award was launched in 2024 in collaboration with SpinUp, a purpose-built laboratory for chemistry and biological work or wet lab incubator at the University of Toronto . The Award is to support early-stage Canadian biotechnology startup companies with the potential to generate transformational therapies in areas that align with AbbVie's therapeutic areas of focus: immunology, oncology, neuroscience, and eye care. Neuropeutics Inc will receive a year of laboratory space at no cost, in addition to access to SpinUp's core equipment, services, entrepreneurship programming, and research talent community at the University of Toronto . Neuropeutics Inc will also benefit from mentorship by AbbVie's scientific and business executives.

For more information on the AbbVie Biotech Innovators Award, please visit: https://spinup.utm.utoronto.ca/biotech-innovators-award/ .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Instagram or find us on LinkedIn .

About SpinUp
SpinUp is the first wet lab startup incubator at the University of Toronto , Canada's leading centre for learning and discovery and one of the world's top-two universities for health science productivity . SpinUp is purpose built to drive life science innovation. It offers early-stage start-ups access to outstanding and highly subsidized wet lab space, equipment, entrepreneurship programming and expertise at a brand new, state-of-the-art research facility at U of T's Mississauga campus. Visit our website at spinup.utm.utoronto.ca and connect with us on Instagram and LinkedIn .

SpinUp is proudly part of U of T Entrepreneurship , a network of 12 accelerators across three campuses. Over the past 10 years, this network has supported more than 1,200 capital-backed companies, which have created 17,000 jobs and raised $12 billion in external investment. U of T now launches more research-based start-ups than any university in North America outside of MIT . The AbbVie Biotech Innovators Award is part of U of T Mississauga's Blue Ticket program at SpinUp, which provides a one-year SpinUp membership.

About Neuropeutics Inc  
Neuropeutics is a for-profit Canadian pharmaceutical company developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. To learn more, please visit us at www.neuropeutics.ca , contact us at info@neuropeutics.ca , and connect with us on LinkedIn .

Neuropeutics Inc CSO & co-founder Dr. Janice Robertson (left) and Dr. Marc Shenouda, CEO & Co-Founder. (CNW Group/AbbVie Canada)

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2025/22/c0315.html

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