Kineta Receives Regulatory Approval for Initiation of KCP506 Trial

Kineta announced the Clinical Trial Application (CTA) approval in the Netherlands for initiation of a first in-human clinical trial of KCP506. KCP506 is a first-in-class α9α10 nicotinic acetylcholine receptor (nAChR) antagonist in development for the treatment of chronic neuropathic pain.

A double-blind, placebo-controlled, single ascending dose and multiple ascending dose study will be conducted in healthy subjects to evaluate the safety, tolerability, and pharmacokinetics of KCP506. The company is planning to initiate the Phase 1 clinical trials of KCP506 in Q4 2020.

"CTA approval of KCP506 marks a critical milestone for Kineta as we prepare to evaluate our novel non-opioid in the clinic," said Kineta CEO Shawn Iadonato. "There is a tremendous unmet need for patients with chronic pain, and we believe that KCP506 has the potential to be a disease modifying therapy without CNS related side effects including addiction."

KCP506 is a novel α9α10 nAChR antagonist in development for the treatment of chronic neuropathic pain. α9α10 nAChR antagonists have demonstrated robust analgesic, anti-neuroinflammatory and neuroprotective effects across multiple preclinical chronic pain models. KCP506 offers the potential for a disease modifying therapy that may slow or halt the progression of chronic pain. KCP506 may potentially be an effective treatment for many types of chronic neuropathic pain including radiculopathy, chemotherapy-induced peripheral neuropathy and diabetic neuropathy. The global neuropathic pain market was $6.3 billion in 2019 and is expected to reach to $9.9 billion by 2027. Kineta established a strategic partnership in April 2018 with Genentech, a member of the Roche Group. The research collaboration is focused on developing first in class α9α10 nAChR antagonists for the treatment of chronic pain.