Avidity Biosciences Highlights FSHD Program at Virtual Investor and Analyst Event
Avidity Biosciences, Inc. (Nasdaq: RNA) announced a live webcast for investors titled "Volume 3: Delivering on AOCs - FSHD" on Dec. 9, 2021, at 11:00 am ET. The company highlighted AOC 1020 as its clinical development candidate for Facioscapulohumeral Muscular Dystrophy (FSHD), which is entering IND-enabling studies. Avidity plans to have three programs in clinical development by the end of 2022, including AOC 1001 for myotonic dystrophy and AOC 1044 for Duchenne Muscular Dystrophy. The MARINA study for DM1 continues with preliminary assessments expected in Q4 2022.
- AOC 1020 is named clinical development candidate for FSHD, entering IND-enabling studies.
- Three programs anticipated in clinical development by the end of 2022.
- Ongoing MARINA study for DM1 with preliminary assessments expected in Q4 2022.
- Dependence on third parties for preclinical testing and product manufacturing.
- Risks associated with the unproven AOC platform and potential delays in clinical trials.
LA JOLLA, Calif., Dec. 9, 2021 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced it will be hosting a live webcast investor and analyst day event titled "Volume 3: Delivering on AOCs - FSHD" at 11:00am ET.
Volume 3 Highlights:
- AOC 1020 named as clinical development candidate for Facioscapulohumeral Muscular Dystrophy (FSHD) program. AOC 1020 is now entering IND-enabling studies.
- Avidity anticipates three programs in clinical development by the end of 2022. Clinical trial initiations for AOC 1020 and AOC 1044, Avidity's lead program for Duchenne Muscular Dystrophy (DMD) targeting Exon 44, are anticipated by the end of 2022.
- AOC 1001 MARINA study in adults with myotonic dystrophy (DM1) is ongoing and continues to enroll patients. Avidity is on track to conduct a preliminary assessment of safety, tolerability and key biomarkers in approximately half of the study participants in the Phase 1/2 MARINA trial in the fourth quarter of 2022.
"It is well known that the inappropriate expression of DUX4 is the underlying cause of FSHD but before now, the technology didn't exist to target it directly. Our AOC platform, combined with our expertise in skeletal muscle diseases, enabled us to design AOC 1020 to directly target DUX4 and reduce its expression," said W. Michael Flanagan, Ph.D., chief technical officer. "We are grateful to have Dr. Jeffrey Statland join today to give a clinical perspective of FSHD and to share the scientific and research advancements being made to better understand this progressive and debilitating disease with no treatment options."
Today's Video Webcast Information
A live video webcast of today's event will be available on the Avidity website at https://aviditybiosciences.investorroom.com/events-and-presentations commencing 8:00 am PT / 11:00am ET. Following the event, a replay will be archived on Avidity's website.
Avidity's management team will be joined by Jeffrey M. Statland, M.D., one of the principal investigators for the multiple clinical studies in FSHD, including the ongoing Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) study and its sub-study, MOVE Plus (MOVE+) being run by the FSHD Clinical Trial Research Network. Dr. Statland is a Professor of Neurology at the University of Kansas Medical Center in Kansas City, Kansas.
About Avidity Biosciences
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity's proprietary AOCs are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to target the root cause of diseases previously untreatable with RNA therapeutics. Avidity is on track to have three programs in clinical development by the end of 2022. The company's lead product candidate, AOC 1001, is designed to treat patients with myotonic dystrophy type 1 (DM1). AOC 1001 has commenced clinical testing with the ongoing Phase 1/2 MARINA™ trial in adults with DM1. The next programs in the company's advancing and expanding pipeline are AOC 1044, the lead of three programs for the treatment of DMD, and AOC 1020, designed to treat people living with FSHD. Avidity anticipates both programs will enter the clinic by the end of 2022. Avidity is also broadening the reach of AOCs beyond muscle tissues through both internal discovery efforts and key partnerships as the company continues to deliver on the RNA revolution. Avidity is headquartered in La Jolla, CA. For more information about our science, pipeline and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
Forward-Looking Statements
Avidity cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential to develop a meaningful pipeline of novel AOC therapeutics; the potential clinical development of AOC 1001 in patients with DM1 and the expected timing of preliminary data from the MARINA trial; the progression of clinical programs for AOC 1044 and AOC 1020 and timing of planned IND-enabling studies and clinical trials; and the broad potential of AOCs to treat rare and serious diseases. The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the business, including, without limitation: Avidity is early in its development efforts; Avidity's approach to the discovery and development of product candidates based on its AOC platform is unproven, and the company does not know whether it will be able to develop any products of commercial value; potential delays in the commencement, enrollment and completion of clinical trials; disruption to its operations from the COVID-19 pandemic; the success of its preclinical studies and clinical trials for the company's product candidates; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; Avidity's dependence on third parties in connection with preclinical testing and product manufacturing; unexpected adverse side effects or inadequate efficacy of its product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; and other risks described in prior press releases and in filings with the Securities and Exchange Commission (SEC). Avidity cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Kathleen Gallagher
(858) 401-7900
kath.gallagher@aviditybio.com
Media Contact:
Cherise Adkins
cadkins@spectrumscience.com
(301) 267-4161
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SOURCE Avidity Biosciences, Inc.
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