Underdog Pharmaceuticals, Inc. (Underdog), a pre-clinical stage pharmaceutical company focusing on the treatment and reversal of age-related diseases, has been awarded an Innovation Passport under the United Kingdom’s Innovative Licensing and Access Pathway (ILAP), to pursue fast patient access to its groundbreaking treatment for cardiovascular disease.
Accounting for more than 40% of deaths in Europe and the United States, and with annual treatment costs more than £29 billion in the UK alone, cardiovascular disease is by far the world’s most life-threatening condition, and its primary cause is atherosclerosis. Underdog’s engineered synthetic carbohydrate compound (an unspecified cyclodextrin derivative) UDP-003, is designed to target and remove toxic oxidized cholesterol, a key driver of arterial plaque accumulation. Underdog is one of the first companies, and UDP-003 one of the very few pre-clinical therapies, to receive an ILAP designation.
ILAP, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) in January, is designed to accelerate development of and access to promising medicines of significant potential public health benefit. The program provides enhanced early input and interactions with MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Health Service (NHS). The ILAP program also provides the potential for significant downstream regulatory advantages, including rolling clinical reviews, accelerated assessment, and supervised early reimbursed use under adaptive authorization.
“This is an honor for us and a wonderful step forward for our program,” said Matthew S. O’Connor, Underdog CEO of Scientific Affairs. “There is an enormous public need for drugs which can significantly reverse established atherosclerosis, rather than manage or delay its onset.”
“I believe the MHRA is sending a powerful message by reviewing and admitting preclinical stage programs like UDP-003 into ILAP,” noted Mike Kope, Underdog CEO of Corporate Affairs. “We’re pursuing a new target, with a new compound and seeking evidence of genuine disease modification; and though the potential is fascinating, the clinical challenges are real. The advice and consultation we’ll receive will be invaluable to the success of the program.”