Abeona Therapeutics Inc. (NASDAQ:ABEO) is about to begin patient enrollment in its pivotal Phase 3 VITAL study of EB-101. The enrollment is resuming after a pause in March 2020 after a strong need to redirect healthcare resources to COVID-19 patients ascended. On the other hand, EB-101, a gene-corrected cell therapy, is viewed as a potential treatment of recessive dystrophic epidermolysis bullosa (RDEB).
The company is doing a phenomenal job even with the COVID-19 crisis; the pharmaceutical industry has to endure just like all other industries. The CEO João Siffert says, they will not be intimidated by the pandemic, instead, they will continue to monitor it to safeguard healthcare professionals and trial participants.
Setting In Motion A Transformational Year at Abeona
Abeona can support commercial launch of producing EB-101 for the VIITAL study. The target patients for enrollment have completed their pre-screening processes at Stanford University, where the trials will be carried out from. The study’s primary goal will have about 15 RDEB patients aged six years and older to obtain at least 50% healing at 12 weeks.
The company has devoted so much effort to be where it is now, and according to Siffert, 2020 should be a transformational year given that the final stages of the program are already in motion. If approved, EB-101 will be the first therapy for RDEB with the potential of addressing large, painful, and debilitating chronic wounds.
Abeona Is Exploring Other Clinical Trials
For the many years that Abeona has been a clinical-stage biopharmaceutical company, it has favored not only the industry but also the FDA and EMA. It has received several regulatory endorsements for various treatments. Some of them, such as Regenerative Medicine Advanced Therapy, are still in the pipeline of development.
Its featured therapies include ABO-201 and ABO-202 for CLN3 disease and CLN1 disease, respectively. Meanwhile, the company has another two ongoing MPS III Phase 1/2 clinical trials, ABO-102 and ABO-101.
It is working closely with sites in its MPS III clinical studies with a high expectation of enrolling more candidates in different programs.