MedinCell demonstrates in vivo the efficacy of the first injectable combining surgical anesthesia and 3 days opioid free postoperative pain management

March 11, 2019

In vivo studies have demonstrated that mdc-CMV offers surgical anesthesia and a minimum of 3 days
of analgesia after a single preoperative injection.

The MedinCell team has selected the lead formulation of the product and is launching its regulatory
preclinical development.

Based on ropivacaine, mdc-CMV is the only known product able to achieve these two therapeutic
objectives. Ropivacaine is a local anesthetic already widely used with a favorable risk/benefit profile.
mdc-CMV aims to:

• improve and simplify postoperative pain management,
• reduce the risk of developing chronic pain after an inadequate management of postoperative pain,
• avoid the use of opioids.

mdc-CMV targets a substantial number of surgical procedures: in the United States alone, 30 million operations performed under anesthesia require postoperative pain management every year.
mdc-CMV is the fourth MedinCell product entering regulatory development (the most advanced is currently in clinical phase 3 in the US). It is also the first fully-owned program of the company to reach this stage.
Human clinical trials should start in the first half of 2020.

The strengths of the project: a single injection combining anesthesia and non-opioid analgesia
mdc-CMV combines the BEPO® technology of MedinCell with a pharmaceutical ingredient already widely used: ropivacaine. In vivo studies demonstrate, on mini pigs, that a perineural injection of the product could allow local surgical anesthesia, followed by at least three days of analgesic effect. In vivo studies also showed the apparent safety profile of the product.

Anesthesia / Analgesia combination after a single injection could make mdc-CMV a unique product on the market. Main anticipated benefits to improve postoperative pain management are:
• A significant reduction in the risk of chronic pain appearing following a surgical procedure.
• An alternative to the opioids currently extensively used for the treatment of postoperative pain. Opioids cause numerous side effects in patients. Their use for pain management can also lead to abuse and addiction. It is currently a major public health issue, particularly in the United States where opioids are responsible for 130 deaths a day according to CDC, the US federal public health agency.
• A reduction in hospital stays, their associated costs and nosocomial infection risks. Outpatient treatment could be facilitated.
mdc-CMV could be used for a large range of surgical procedures, notably in orthopedic field. The opioid-free postoperative pain management market is growing with players such as Pacira (Exparel®) or Heron Therapeutics (HTX-011, currently awaiting market authorization). These products use bupivacaine, which is more toxic at cardiac and neurological levels than ropivacaine.
MedinCell develops a multimodal approach to opioid-free pain management with, in addition to the mdc-CMV program:
• mdc-CWM, for the treatment of postoperative pain and inflammation in orthopedic surgery
currently in phase 2 clinical trials in the United States,
• mdv-NVA, for the treatment of chronic post traumatic peripheral neuropathic pain over 4 weeks currently in the lead formulation selection phase.

Next steps for the product portfolio
The launch of regulatory preclinical studies with mdc-CMV is part of the ongoing momentum to expand
the portfolio of MedinCell, which includes both in-house products and products developed within the framework of partnerships. mdc-CMV is the fourth product of MedinCell currently in development, thus joining the three most-advanced programs of the Company for which major milestones are expected in the upcoming months:
• Currently in a Phase 3 clinical study in the United States, the efficacy results of the mdc-IRM program for the maintenance treatment of schizophrenia should be available by the end of the year.
• The results of the Phase 2 clinical trial currently ongoing in the United States with the mdcCWM product for the treatment of postoperative inflammation and pain in orthopedic surgery are also expected this year.
• In the CNS field, the mdc-TJK program could enter clinical development by the end of the summer.
The portfolio of MedinCell also includes six other products in various therapeutic areas that are currently in the lead formulation selection phase, developed in-house or with the support of partners. Some of them could also enter regulatory preclinical development in the coming months. Addressing a number of different therapeutic areas and indications, all the products in the portfolio of MedinCell are based on active pharmaceutical ingredients already widely used with demonstrated efficacy and safety. These programs have a particularly attractive risk/benefit profile and can be entitled to accelerated development processes.

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