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AVROBIO Outlines Response to COVID-19 and Current Assessment of Business Impact
AVROBIO Outlines Response to COVID-19 and Current Assessment of Business Impact
Patient identification for clinical trials continues; dosing temporarily paused as clinical trial sites focus on COVID-19 pandemic
Essential laboratory and manufacturing activities currently uninterrupted
Cash runway into Q2 2022
“Our first priority during this unprecedented time is the health of our employees, our patients and their communities, and the employees of our clinical sites, partners and vendors. In accordance with advice from health authorities,
Program Updates
AVR-RD-01 clinical trials in Fabry disease
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Patient identification activities for the FAB-201 trial continue in
Australia ,Canada and theU.S. - We anticipate patient enrollment and dosing will resume as hospitals allow.
- Ongoing data collection is expected to continue for dosed patients in both trials; timing could be impacted by duration of COVID-19-related interruptions.
AVR-RD-04 Phase 1/2 clinical trial in cystinosis
AVROBIO’s investigational gene therapy for cystinosis (AVR-RD-04) is being studied in a Phase 1/2 investigational trial in collaboration with the
- Patient identification activities continue.
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A second patient in the study has been enrolled and has completed apheresis. Cryopreserved drug product for that patient has been manufactured and dosing is expected to occur as soon as the
UCSD clinical site allows. - Ongoing data collection is expected to continue for the first patient dosed in the trial; timing could be impacted by duration of COVID-19-related interruptions.
AVR-RD-02 Phase 1/2 clinical trial in Gaucher disease
- Patient identification activities continue.
- The first patient in the trial has been enrolled and has completed apheresis. Cryopreserved drug product for that patient has been manufactured and dosing is currently anticipated for Q2 2020, but is dependent on when the clinical site allows.
- Subsequent new patient dosing is anticipated in the second half of the year, as hospitals allow.
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About
Our mission is to free people from a lifetime of genetic disease with a single dose of gene therapy. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease.
Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,” “anticipates,” “believes,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, the expected benefits and results of our implementation of the plato platform in our clinical trials and gene therapy programs, the expected safety profile of our investigational gene therapies, the potential impact of the COVID-19 outbreak on our clinical trial programs and business generally, as well as our plans and expectations with respect to the timing and resumption of any development activities that may be temporarily paused as a result of the COVID-19 outbreak, and statements regarding our financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.
Any forward-looking statements in this press release are based on AVROBIO’s current expectations, estimates and projections about our industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIO’s product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of
Cautionary Note on Future Updates
The statements contained in this press release reflect our current views with respect to future events, which may change significantly as the global consequences of the COVID-19 pandemic rapidly develop. Accordingly, we do not undertake and specifically disclaim any obligation to update any forward-looking statements.
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