Dyne Therapeutics Announces FDA Clinical Hold of IND Application for DYNE-251 in Duchenne Muscular Dystrophy

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WALTHAM, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc.. (Nasdaq: DYN), a muscle disease company focused on advancing innovative therapies that transform the lives of people with genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) Unis has clinically suspended its Investigational New Drug (IND) application to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) likely to skip exon 51. Dyne has received a letter of d clinical pending from the FDA on Friday, January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251. The company plans to submit its response to the FDA with data from existing and ongoing studies in the second quarter of 2022, and if satisfactory to the FDA, to dose patients in a Phase 1/2 clinical trial at multiple escalating doses (MAD) of DYNE-251 by mid-2022 in line with its current guidance. Dyne will work closely with the FDA to resolve the clinical blockage as quickly as possible.

As previously announced, the Company expects to submit an IND for DYNE-101 in myotonic dystrophy type 1 (DM1) in the first quarter of 2022 and to dose 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 therapies that transform the lives of people with genetic diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapies designed to overcome the delivery limitations 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.

Forward-looking statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding Dyne’s strategy, future operations, outlook and plans, management objectives, platform potential, FORCE form, the expected timeframe for submitting its response to the FDA, the clinical expectation letter, the submission of Investigational New Drug Applications and patient dosing in trials and the planned trial design, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “could”, “goal”, “ongoing”, “plan”, “predict”, “project”, “potential”, “should” or “would”, or the negative form of these terms, or any other terminology comparable are intended to identify forward-looking statements, although all forward-looking statements do not contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements due to various important factors, including: the uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties regarding the availability and timing of results from preclinical studies; uncertainties regarding the timing and ability of Dyne to submit and obtain regulatory approval for Investigational New Drug Applications and to initiate clinical trials, including with respect to its response to the DYNE Clinical Hold Letter -251 and its ability to obtain regulatory clearance from DYNE-251 IND; whether the results of preclinical studies will be predictive of the results of preclinical studies and subsequent clinical trials; whether investigators and regulators will agree with the design of Dyne’s planned clinical trials; whether Dyne’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure needs; uncertainties associated with the impact of the COVID-19 pandemic on Dyne’s business and operations; and the risks and uncertainties identified in Dyne’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-Q and in Dyne’s subsequent filings with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will result in a change of opinion. However, while Dyne may choose to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be taken to represent the views of Dyne as of any date subsequent to the date of this press release.

Contact:

Therapeutic Dyne
Amy Reilly
[email protected]
857-341-1203

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