NFL legend Brett Favre involved with Melbourne trials of world-first concussion treatment

February 4, 2022

NFL Hall of Fame Quarterback Brett Favre is one of the high profile personalities having made headlines for his push to improve concussion treatments and protocols in the NFL, as well as other contact sports around the world.

Clinical trials are currently being administered by Nucleus Network at their Melbourne clinic for an innovative medication to treat concussion developed by Odyssey Group International, Inc. with Favre involved in the company developing the concussion treatment as a sports advisory board member. While Favre won’t be one of the volunteers in the Phase 1 trial, he is involved in overseeing the process of evaluating the treatment.

Odyssey Group International, Inc - a medical company focused on developing unique, life-saving medical products - have developed the drug candidate PRV-002 to treat concussion as a novel neurosteroid, which can be inhaled through the nose as a powder, with preliminary data suggesting it can reduce the seriousness of a concussion by reducing brain swelling, maintaining blood flow to affected areas of the brain, and potentially reducing cell death in the brain if administered early.

Dr Philip Ryan, Principal Investigator at Nucleus Network notes “the potential benefits of an easily-administered concussion treatment are enormous. We are excited to be evaluating this treatment, especially with Australia’s passion around sports in general and contact sports in particular has brought concussion and related injuries into the national discussion. The effects of concussion remain a significant concern to people who participate in those sports and their families.”

Concussion and brain injury has become a major talking point in sport in recent years. Ex-AFL and NRL players in particular have spoken out about the long-term effects of repeated concussions. A new development has the potential to reduce the impact of concussion, with a simple, easy-to-use treatment that can be kept in a simple first-aid kit, which could be used in sports, motor accidents or even by the military.

According to the Australian Bureau of Statistics, almost 700,000 Australians live with a brain injury, with as many as two-thirds of these suffering from the condition before the age of 25.

In younger people, the major cause of Traumatic Brain Injury (TBI) is motor vehicle accidents, followed by sporting injuries, with many sporting bodies in Australia signing up to an “If in doubt, sit them out” method of treating potential concussions, as per the Concussion in sport guidelines.

In the USA, the Centres for Disease Control (CDC) estimate that there are between 1.6 and 3.8 million sports-related concussions annually in the US, and 230,000 require hospitalisation. Australia has a similar rate, with more than 20,000 hospital admissions due to concussion per year.

There have been many reports written on the effect of concussion in sport, both at a professional and amateur level, with major concern given to the long-term effects of repeated concussions leading to serious conditions such as Chronic traumatic encephalopathy (CTE). The impact of concussion and TBI has also been noted by many health organisations, including the Australian Government, with $50 million invested in The Traumatic Brain Injury Mission, a research funding program aimed at improving patient recovery after brain injury.

Favre highlights “In my 19 years of playing, I’d take 20-30 hits per game. There wasn’t one game that I can remember that I didn’t have my bell rung. Seeing stars or fireworks back then was just part of the game. Now, there’s protocols for concussion to try and alleviate the problem, but there isn’t a treatment available yet to reduce the impact.

“Changing in rules to protect players and improve protection equipment is helpful, but as players become bigger, faster and stronger, the hits get harder. The guys playing now are much bigger and faster than they have ever been before.

“It’s not just people who play contact sports that suffer from it though,” he adds. “It is very common in the military, in car accidents, even just slipping on an icy sidewalk can give you a concussion that can impact your life.”

“There’s no real treatment available at the moment, so when there’s a promising treatment that could help, such as Odyssey’s PRV-002, I’m hopeful that it will help take away some of the consequences of CTE and other brain injuries.”

Diagnosing a concussion is difficult, with no specific diagnostic test available. Often medical professionals rely on analysing the behaviour of the affected person, basing their initial diagnosis on whether there is any dizziness, nausea or headache, and whether the person appears to be dazed, stunned or disoriented.

Convenience of the treatment
With rapid treatment being a key factor in reducing the severity of a brain injury, being able to administer the medication quickly, effectively and safely is critical. The delivery method is a unique dosing device that allows an individual to blow the powder into their own nasal cavity.

The design of the device was an important challenge in the development of this product, with the goal that it should be easily stored and administered in urgent situations, such as motor vehicle accidents or sporting injuries.

To use the device, the safety cap is removed, and the device is inserted into a single nostril at one end and in the mouth at the other (as clearly indicated on the device). Intranasal delivery is performed by sharply exhaling through the device.

An innovative approach to concussion treatment
Other than pain relief and anti-depressants, there are currently no approved pharmacological therapies for TBI.

The PRV-002 medication is derived from Progesterone, a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal glands. It has been used safely in humans for several different conditions. While Progesterone has been available in tablets, gels and intramuscular injections, this novel way of administering PRV-002 allows for a safer and faster method of delivery, as well as convenient storage in medical kits that can be carried by emergency services or appropriate medical staff at sporting events.

Jacob VanLandingham, Executive VP of Drug Development of Odyssey Group International enthused “we are so excited about enrolment for our human trials and to establish a strong safety profile following PRV-002 nasal application. These studies will look at pharmacokinetics and drug tolerability at three dosage strengths. The most tolerated dose will be used in the subsequent trials to determine efficacy.”

“We are so excited to be running our clinical trials for the first concussion pharmaceutical treatment in Australia. The Nucleus Network and Avance Clinical teams are incredible partners. Combatting brain inflammation early on will help protect the brains of our youth athletes” said Brett Favre.

Nucleus Network is administering the trial at their Melbourne clinic and is seeking people willing to participate in evaluating this valuable treatment.

The trial will be a double-blind, placebo-controlled study of healthy participants, administered through Nucleus Network’s Melbourne site. Anyone interested in participating in this or other vital clinical trials can register their details at https://www.nucleusnetwork.com/participate-in-a-trial or speak to one of our team members on 1800 243 733.

For more information on the Odyssey Group International, Inc go to odysseygi.com

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