Pain and hearing loss are chronic disorders that affect >100M patients in the EU alone and represent a large healthcare burden due to limited, non-optimal treatment options. With the aging population and longer survival after cancer therapies (chemotherapy-induced chronic pain), these problems are on the rise.
Patients suffering from chronic neuropathic pain are treated with drugs that were originally developed as antiepileptics, antidepressants, and opioids. While these drugs offer some pain relief to some, they leave a large part of patients still in need for safe, efficacious, and well-tolerated treatments. These drugs act on targets located in the central nervous system, giving rise to adverse effects as dizziness, fatigue, and cognitive problems. Opioid use may lead to development of tolerance, addiction, and abuse. A large part of people offered the available drugs will discontinue chemotherapy treatment, either due to lack of effect, or an unacceptable burden of side effects.
Patients with hearing loss are left with no other options than hearing devices, which only offer enhancement of the sense of hearing; but cannot offer any reparative actions on the underlying neural circuitry.
Hoba Therapeutics holds rights to, and is developing, two molecules, representing a novel family of neuronal growth factors with unique effects on sensory nerve cells and systems. Their features, which include restorative and regenerative effects on lesioned nerve cells, make them strong candidates as novel medical treatments for pain disorders and hearing loss, our target indications. Solid preclinical data generated and validated across several sites suggest superior effects on pain symptoms along with a potential for a prevention effect and signs of restorative effects on nervous tissue.
The actions of HB-086 and HB-097 on sensory nerve cells represent a novel therapeutic approach and a paradigm shift for medical treatment and prevention of chronic pain disorders and hearing loss. Both conditions are associated with dysfunction of groups of nerve cells located near the spinal cord in the case of pain and in the inner ear, in the case of hearing loss. Sensory neurons are essential for perception of external stimuli e.g. sound, touch, injury, smell. HB-086 and HB-097 target cellular systems that are necessary for the function of sensory nerve cells and support cells. Evidence indicates a mode of action which includes normalization of impaired neuronal-glial crosstalk, protection and regeneration of nerve cells and fibers. Our experimental data confirm that HB-086 completely abolishes pain in a number of different models and HB-097 preserves the sense of hearing in relevant models. Treatment effects are long-lasting and indicate a potential for infrequent dosing and prevention of further disease progression.
The overall objective of this EIC accelerator project is to progress the HB-086 and HB-097 to clinical development and obtain clinical proof of principle in humans. The transition from preclinical development to testing first in healthy volunteers and then patients require the generation of a substantial regulatory data package. The objective includes 8 work packages that will provide the supportive data.
www.hobatherapeutics.com
