Kineta Receives Regulatory Approval for Initiation of Phase 1 Clinical Trials of KCP506
First in-human clinical trials will evaluate the safety and pharmacokinetics of a first-in-class α9α10 nicotinic acetylcholine receptor antagonist
Seattle, WA — (August 12, 2020) Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense announced today 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.
Kineta, Inc. is a clinical stage biotechnology company committed to developing disruptive life science technologies that address unmet patient needs. We have leveraged our expertise in immunology to advance a focused pipeline of investigational drugs in oncology, neuroscience and biodefense. We actively collaborate with a broad array of private, government and industry partners to advance our innovative products. For more information on Kineta visit our website, www.kinetabio.com, follow us on Twitter at @kinetabio, LinkedIn and Like us on facebook.com/KinetaBio.
NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s and Kineta Chronic Pain, LLC’s (KCP) plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s and KCP’s businesses which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and neither Kineta nor KCP undertake any obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Contact Jacques Bouchy