WALTHAM, MA, USA I January 18, 2022 I Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed on clinical hold its 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. Dyne received a clinical hold letter from the FDA on Friday, January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251. The Company expects to submit to the FDA its response with data from existing and ongoing studies in the second quarter of 2022, and if satisfactory to the FDA, to be dosing patients in a Phase 1/2 multiple ascending dose (MAD) clinical trial of DYNE-251 by mid-2022 in accordance with its current guidance. Dyne will work closely with the FDA to resolve the clinical hold as promptly as possible.
As previously announced, the Company expects to submit an IND for DYNE-101 in myotonic dystrophy type 1 (DM1) during the first quarter of 2022 and to be dosing patients in a planned MAD clinical trial by mid-2022.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company dedicated to 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 seen with other approaches. Dyne has a broad portfolio of therapeutic candidates for serious muscle diseases, including myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
SOURCE: Dyne Therapeutics
Post Views: 169
WALTHAM, MA, USA I January 18, 2022 I Dyne Therapeutics, Inc. (Nasdaq: DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed on clinical hold its 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. Dyne received a clinical hold letter from the FDA on Friday, January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251. The Company expects to submit to the FDA its response with data from existing and ongoing studies in the second quarter of 2022, and if satisfactory to the FDA, to be dosing patients in a Phase 1/2 multiple ascending dose (MAD) clinical trial of DYNE-251 by mid-2022 in accordance with its current guidance. Dyne will work closely with the FDA to resolve the clinical hold as promptly as possible.
As previously announced, the Company expects to submit an IND for DYNE-101 in myotonic dystrophy type 1 (DM1) during the first quarter of 2022 and to be dosing patients in a planned MAD clinical trial by mid-2022.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company dedicated to 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 seen with other approaches. Dyne has a broad portfolio of therapeutic candidates for serious muscle diseases, including myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
SOURCE: Dyne Therapeutics
Post Views: 169