MAC Clinical Research (MAC) announces regulatory approval to initiate a PII clinical trial for mavatrep, an investigational, oral, TRPV1-receptor (transient receptor potential cation channel vanilloid type 1 receptor), selective competitive antagonist intended to target the treatment of chronic osteoarthritis pain.
Chronic pain, and specifically chronic osteoarthritis pain, is one of the most disabling conditions worldwide. Treatment with ineffective products results in repeat visits to healthcare professionals and this has been identified as a driver of increased drug costs. Mavatrep is an attractive asset for development to relieve chronic pain because it may lack the potentially serious side effects seen with current standard of care treatments, such as cardiovascular and gastrointestinal side effects seen with nonsteroidal anti-inflammatory drugs. TRPV1 is one of the best-characterised and widely validated members of the TRP channel family, and it plays an essential role in pain physiology and neurogenic inflammation.
In previous Phase 1 clinical studies, mavatrep was found to be safe and well-tolerated with a relatively long-half-life. Mavatrep also demonstrated efficacy in patients with chronic osteoarthritic pain. The reduction of pain produced by mavatrep is dose and concentration-dependent, suggesting that these effects are mediated through engagement of the TRPV1 receptor in vivo in humans. MAC has now had regulatory approval to proceed the Phase IIb study in chronic osteoarthritis pain and are pleased to confirm the first cohort for dosing was completed the first week of May 2025.
Commenting on this development, Dr. Steve Higham, President of MAC, said: “We are delighted to be developing mavatrep. Our hope is that it will be successful and provide benefit to the millions of people, worldwide, who suffer from chronic pain without the potential for serious side effects.”
MAC is conducting these activities under a Johnson & Johnson Innovation facilitated agreement from Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
About MAC:
MAC Clinical Research is one of Europe’s largest independent contract research organisations (CROs), committed to providing full-service delivery of global clinical studies. Headquartered in the UK with offices globally, we conduct studies both through our fully-owned network of dedicated research sites and through contracting with other sites and networks, world-wide. We offer the global clinical study management needed to meet clinical outcome goals. MAC’s heritage stems from being the first memory assessment centre based in Europe, and the company now conducts research for sponsors over an ever-expanding group of therapeutic areas. MAC has an extensive range of clinical research capabilities to accommodate the most complex Phase I trials (in their MHRA-accredited Phase I unit) through to Phase IV (across their network of late-phase dedicated research sites). The company’s key therapeutic areas of expertise include diseases of the central nervous system (CNS), pain (acute and chronic), dermatology, rheumatology, endocrinology, and functional psychiatry.
