SAN711 for treatment of chronic itching and neuropathic pain

SAN711 is a first-in-class pain and itch-relieving compound, which has the potential to be a first-line treatment option for pain management in patients suffering from untreatable neuropathic pain or itching disorders, either as a standalone treatment or as an add-on medication to existing suboptimal therapies. SAN711 acts on the receptors for GABA, the main inhibitory signaling mediator in the nervous system. SAN711 works selectively on receptors containing the GABAA α3 proteins without acting on the main GABAA receptors. This implies that SAN711 may regulate the body's own pain and itch regulating system in the spinal cord without causing side effects. This concept has been supported by preclinical studies with the compound. SAN711 is a new chemical entity and Saniona has filed a compound patent, which may provide patent protection until 2038.

In February 2019, Saniona successfully completed preclinical development of SAN711, and the program is ready for Phase 1 clinical trials, which may start during the summer 2019, either internally or together with a potential partner.

Chronic itching/pruritus

Pruritus or itch is the most frequent symptom seen in skin disease, including atopic dermatitis, urticaria and psoriasis. Pruritus is often defined as an unpleasant sensation associated with the desire to scratch and significantly reduces the quality of life of the affected individuals. With a lifetime prevalence of up to 22% and a high rate of therapeutic failure due to suboptimal treatment options, chronic itch imposes a significant socio-economic burden. Antihistamines have traditionally been the first-line treatment option for most pruritic conditions despite low efficacy in the substantial number of pruritic diseases characterized by histamine-independent pruritus. Certain systemic diseases have long been known to cause pruritus that ranges in intensity from a mild annoyance to an intractable, disabling condition. Generalized pruritus may be classified into the following categories based on the underlying causative disease: renal pruritus, cholestatic pruritus, hematologic pruritus, endocrine pruritus, pruritus related to malignancy, and idiopathic generalized pruritus. The global combined market for treatment of atopic dermatitis and psoriasis amounts to approximately US$10 billion and is expected to double over the next 10 years.

Neuropathic pain

Neuropathic pain is caused by a lesion or dysfunction of the central or peripheral nervous system in diseases such as diabetes, varicella zoster, cancer and HIV, or following mechanical lesion and trauma or the use of drugs such as chemotherapy. Neuropathic pain is often chronic, irreversible and notoriously difficult to manage. According to industry estimates, neuropathic pain is believed to affect about 40 million people in seven major markets. Major indications include chronic lower-back pain, painful diabetic neuropathy, post herpetic neuralgia (following shingles), neuropathic cancer pain and HIV related neuropathic pain. Well-known painkillers, such as Aspirin®, Panodil®, and ibuprofen have no or little effect on neuropathic pain. Apart from narcotic analgesics (where tolerance development is a further complication), patients are typically treated with drugs developed for other indications including anti-epileptic drugs and antidepressants. Furthermore, the existing drugs typically have significant and dose-limiting side effects such as drowsiness, dizziness and somnolence. The market for neuropathic pain is estimated to be approximately US$6 billion with an anti-epileptic drug being the current market leader. It is estimated that 40-60% of the treated patients do not respond to existing drugs and that those who do only achieve partial pain relief, creating a significant medical need for more effective treatments.