Phase 1 Data Published in Nature Communications Show Potential of mRNA Encoding VEGF-A as a Regenerative Therapeutic
Tolerability: AZD8601 was well tolerated when administered directly into the skin
Protein Expression: Demonstrated dose-dependent protein translation
Protein Pharmacology: mRNA injected directly into skin of patients showed evidence of increased blood flow
AZD8601 now in an ongoing Phase 2a study with patients receiving epicardial injections of VEGF-A mRNA during coronary artery bypass grafting surgery
The Phase 1a/b study, conducted with
“I believe this is an important milestone in the field of mRNA therapeutics as it starts to address many questions regarding the safety and delivery of mRNA to human tissues, the duration and level of the protein that can be expressed and the ability of the technology to have a physiologic, measurable function over a prolonged period of time,” said
The study showed VEGF-A protein post injection of AZD8601 was increased above the pre-specified expected threshold, as measured by skin microdialysis. At each sampling time, mean VEGF-A protein levels, across all mRNA-treated sites from patients across all cohorts, were higher than that of placebo up to the 24-26 hour time point in the study. The bioactivity of the VEGF-A protein post injection of AZD8601 was also observed by an increase in blood flow at injection sites up to seven days following a single injection, as measured by laser doppler imaging. The only treatment-related adverse events reported were mild injection-site reactions, and the treatment was overall well tolerated.
“We are encouraged by these initial data as they support the ability of AZD8601 to transiently produce pharmacologically active amounts of VEGF-A protein, which may in the future regenerate blood vessels for patients with ischemic cardiovascular disease,” said
“Despite significant advances in treatment over the past 30 years, up to 45 percent of people with heart failure worldwide do not survive past a year of being discharged from hospital,” said
A link to the publication, Intradermal Delivery of Modified mRNA Encoding VEGF-A in Patients with Type 2 Diabetes (Gan LM, et. al.), can be found here.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning: the potential of mRNA encoding for VEGF-A to benefit patients where proper blood flow is compromised in areas such as heart disease and diabetes as well as for other vascular complications and its potential to regenerate blood vessels for patients with ischemic cardiovascular disease; the ability of Moderna’s mRNA to produce therapeutic levels of protein; and the potential of mRNA encoding for VEGF-A to offer a therapeutic approach in improving cardiac function. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors include, among others: preclinical and clinical development is lengthy and uncertain, especially for a new category of medicines such as mRNA, and therefore Moderna’s preclinical programs or development candidates may be delayed, terminated, or may never advance in the clinic; no mRNA drug has been approved in this new potential category of medicines, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of medicines; and those described in Moderna’s Prospectus filed with the
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