Two additional studies will run in parallel with planned clinical trial in postherpetic neuralgia patients.
Spinifex Pharmaceuticals received A$6.25 million (about $6.54 million) of venture capital investment from investors for the development of its pain-management drug, EMA401. This expanded Series B round adds to the previously reported A$12 million investment.
Money will be used to expand the Phase II program into two additional indications: pain and hypersensitivity in peripheral nerve injury patients as well as pain and hypersensitivity in cancer chemotherapy patients. The studies will run alongside a soon-to-be initiated Phase II study of EMA401 in postherpetic neuralgia.
EMA401 is an angiotensin II type 2 (AT2) receptor antagonist. The discovery that this class of molecules offers an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at the University of Queensland.
After licensing the technology, Spinifex conducted preclinical and early clinical development. EMA401 has shown efficacy in a number of relevant models and good human safety and pharmacokinetics in Phase I studies, the company reports.
Spinifex has a collaboration with Praveen Anand, professor of clinical neurology at Imperial College London’s Hammersmith Hospital, and his research laboratory. “Building on professor Smith’s original discovery, professor Anand’s studies on the AT2 receptor in tissue samples collected from patients with different neurological conditions have demonstrated a clear rationale for the use of AT2 receptor antagonists in a number of painful conditions, and we have used this data to select these important additional clinical indications,” says Spinifex CEO Tom McCarthy.
Professor Anand adds, “Our innovative study designs incorporate new functional pain biomarkers and correlative histological assessments. In addition, the selection of the clinical indications was informed by a broad assessment of AT2 receptor localization in somatic and visceral pain pathways and functional studies in isolated human neurons to better define clinical doses.”