Business
Dyne Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights
- Initiation of Patient Dosing in Multiple Ascending Dose Clinical Trials for DYNE-251 in DMD and DYNE-101 in DM1 Anticipated in Mid-2022 - WALTHAM, Mass.,
About this update from Dyne Therapeutics, Inc.
[{"type":"text","content":"- Initiation of Patient Dosing in Multiple Ascending Dose Clinical Trials for DYNE-251 in DMD and DYNE-101 in DM1 Anticipated in Mid-2022 - WALTHAM, Mass., May 02, 2022 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the first quarter of 2022 and business highlights. “We are fully focused on advancing multiple programs to the clinic. We are executing on our plans to submit in the second quarter our response to the FDA relating to our IND for DYNE-251 in DMD as well as regulatory filings in multiple countries for DYNE-101 in DM1 with the goal to initiate patient dosing for both of these candidates in mid-2022. We also continue to engage with thought leaders, advocacy groups and patients to support rapid initiation of dosing for our planned multiple ascending dose clinical trials,” said Joshua Brumm, president and chief executive officer of Dyne. “We are proud of the extensive preclinical data we have generated for our programs to date and the work the team has done to advance DYNE-251 and DYNE-101 towards the clinic – a major step in our mission to deliver life-transforming therapies for people with serious muscle diseases.” Upcoming Events and Milestones Dyne is executing on its plans for the second quarter of 2022 to: submit its response to the U.S. Food and Drug Administration’s clinical hold letter for the Investigational New Drug (IND) application to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) amenable to skipping exon 51; andsubmit regulatory filings in multiple countries for DYNE-101 in myotonic dystrophy type 1 (DM1). The Company expects to initiate patient dosing in global multiple ascending dose (MAD) clinical trials for DYNE-251 in DMD and DYNE-101 in DM1 in mid-2022, subject to clearance from applicable regulatory authorities.Additional preclinical data from Dyne’s DM1 program will be highlighted during the 25th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), being held May 16-19, 2022, in Washington, D.C. and virtually. The oral presentation entitled, “Repeat Dosing with DYNE-101 is Well Tolerated and Leads to a Sustained Reduction of DMPK RNA Expression in Key Musc...