Connectyx Technologies Holdings Group, Inc. (OTC: CTYX) (“Connectyx” or the “Company”), a development-stage biomedical company focusing on novel treatments for rare diseases, announced today the Company has signed a definitive agreement with Mid-Atlantic BioTherapeutics, Inc. (MABT) to acquire worldwide rights for the development of IMT504, a novel, patented immunotherapy, to treat symptomatic rabies. IMT504 is being developed to treat patients whose disease has progressed beyond the stage where it can be treated by the existing approved rabies vaccines.
IMT504 has been granted orphan drug designation in the US, which provides significant benefits including tax credits, market exclusivity and waiver of certain FDA fees. Rabies is one of only 14 diseases which qualify for the FDA Tropical Disease Priority Review Voucher (PRV) Program that is granted to sponsors of approved tropical disease product applications that meet certain criteria.
Once the sponsor obtains a PRV, the voucher can be used to obtain priority review designation for a subsequent application that does not itself qualify for priority review as described in the guidance. Because Priority Review Vouchers (PRVs) may be sold, a secondary market for the vouchers has emerged, and their value has increased. In 2016–2018, the value of a voucher ranged from $125 million to $200 million.
Paul M. Michaels, Connectyx CEO said. “Since 2001, over a million people worldwide have died from rabies. While the number is fortunately small in the U.S., in much of the world it is still a significant problem with no treatment options for patients who have progressed to late-stage rabies disease. Our goal is to be in the clinic by Q1 2022. As a result of the near 100% fatality rate in late-stage rabies, we anticipate being able to implement an adaptive clinical trial strategy that could lead to rapid FDA approval.”
MABT CEO David Horn, M.D. commented that “Rabies is a devastating illness with the highest fatality rate of any infectious disease. Our goal at MABT is to provide the first viable treatment option for patients suffering from advanced rabies disease, using our novel IMT504 immunotherapy platform. IMT504 has the potential to change the way numerous infectious diseases are treated by safely and effectively augmenting the host immune response to combat aggressive pathogens.”
About Mid-Atlantic BioTherapeutics, Inc. https://mabt.us/
Mid-Atlantic BioTherapeutics was founded in 2011 with the mission of eradicating infectious diseases. MABT is a clinical-stage pharmaceutical company focused on the clinical development and commercialization of novel anti-infective approaches, such as the patented IMT504 immunotherapy platform that harnesses the body’s own immune response to fight off infections. The company is actively addressing the growing antibiotic resistance problems and creating a revolutionary treatment paradigm for bacterial and viral diseases, emerging infectious diseases and biodefense.
About Connectyx Technologies Holdings Group, Inc. http://connectyx.com/
Connectyx is a development-stage biomedical company focusing on novel treatments for rare diseases. The Company also focuses on therapies with potentially accelerated development paths as a result of the indication, the nature of the therapeutic itself, or the stage of clinical development. The Company is transforming through the acquisition, in-licensing and sub-licensing of new technologies. At Connectyx, we envision a world where all patients have a therapeutic option.
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