Month: March 2021

Special Report: Incannex Healthcare (ASX:IHL) is making steady progress on its hydroxychloroquine (HCQ)/cannabidiol (CBD) drug combination and will be meeting with US regulators shortly on an approval pathway.

The Melbourne-based pharmaceutical development company says it has a pre-investigational new drug (IND) meeting with the US Food and Drug Administration after submitting a comprehensive information package on IHL-675A and its proposed use in preventing Acute Respiratory Distress Syndrome (ARDS) and Sepsis Associated Acute Respiratory Distress Syndrome (SAARDS), a leading cause of death from COVID-19.

Some 10 to 15 per cent of all patients admitted to intensive care have ARDS, a life-threatening injury characterised by fluid leaking into the lungs, according to Incannex.

Patients with ARDS often have poor outcomes, as the ventilators typically only treat the symptoms rather than the inflammation that’s driving the disease.

The FDA says it will try to provide comment on Incannex’s drug development proposal by April 21, after which time Incannex will formalise its clinical development plans.

FDA members from across the agency, including representatives from medical, pharmacology and chemistry, manufacturing and control (CMC) divisions will provide feedback on Incannex’s plans.

“The United States is the largest pharmaceutical market in the world, so being granted a Pre-IND meeting review with FDA represents an important milestone for our company and a strong foundation for the clinical development of IHL-675A,” says Incannex managing director and chief executive Joel Latham.

Seven separate preclinical trials on IHL-675A have indicated the drug cocktail is a potent anti-inflammatory. The animal tests indicate that CBD and hydroxychloroquine work together synergistically to reduce inflammation.

In consultation with the FDA, Incannex intends to expand its development to include pulmonary neutrophilia, inflammatory bowel disease and rheumatoid arthritis.

“Our preclinical studies have demonstrated that IHL-675A has the potential to be a platform drug applicable to the treatment of multiple indications,” says Latham.

“We anticipate the work completed on the FDA information package for IHL-675A for ARDS and SAARDS will assist us with hastening submissions to FDA for the other indications being pursued.”

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Special Report: Incannex Healthcare (ASX:IHL) hydroxychloroquine/cannabidiol (CBD) cocktail is turning into a veritable wonder drug – at least in rodents.

The Melbourne-based pharmaceutical development company announced on Tuesday that it would pursue using IHL-675A to treat rheumatoid arthritis, following promising tests on laboratory rats induced to have arthritis.

It’s the sixth inflammatory condition the drug combination has shown efficacy in treating: Incannex has previously announced positive results for IHL-675A in animal studies involving asthma, constructive obstructive pulmonary disease (COPD), inflammatory bowel disease, bronchitis and sepsis-associated acute respiratory distress syndrome, a leading cause of death from COVID-19.

All the lab tests indicate that CBD and hydroxychloroquine work together synergistically to reduce inflammation.

Hydroxychloroquine is already approved for treating rheumatoid arthritis and is sold under the brand name Plaquenil, but long-term use can cause heart damage and inflame the optic nerve.

The medication became hard to find after then-US President Donald Trump infamously spruiked it as a treatment for COVID-19 last year.

This latest animal study suggests by combining hydroxychloroquine with CBD, there could be a tenfold reduction in hydroxychloroquine without sacrificing efficacy in arthritis treatment.

“The observation … indicates that IHL-675A has the potential to be a breakthrough in the treatment of rheumatoid arthritis in humans,” says Incannex chief executive and managing director Joel Latham.

“Therefore, the company is rigorously working with its scientific team and advisors to arrange the next steps to advance IHL-675A for use in patients with rheumatoid arthritis.”

A global disease

An autoimmune disorder, rheumatoid arthritis affected an estimated 24.5 million people in 2015.

The chronic inflammatory disorder occurs when the immune system mistakenly attacks a body’s own tissue, including the lining of the joints, causing painful swelling and stiffness.

Incannex said it had broadened claims within its patent filing to cover rheumatoid arthritis as an indication.

The company has also hired consultants and requested a meeting with the US Food and Drug Administration so it can develop a path forward with clinical studies.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

The post Incannex will pursue a SIXTH possible use for its experimental drug cocktail: treating rheumatoid arthritis appeared first on Stockhead.

The new study could accelerate the pathway to Phase 2 clinical trials for IHL’s proprietary drug treatment.

Clinical-stage cannabis and psychedelic biotech Incannex Healthcare (ASX:IHX) has been steadily building the development pathway to test the effectiveness of its IHL-216A in the treatment of sports concussion.

And this morning, the company announced that it’s partnering with a leading research team at Monash University for the next phase of testing.

Working with the Monash Trauma Group at the university’s Department of Neuroscience, the study will test the protective effect of IHL216A, using a unique model developed in conjunction with the US National Football League (NFL).

The NFL concussion model study marks the next step in the testing pathway for IHL-216A, after an in vivo study on rodents in December confirmed the drug’s capacity to protect against secondary brain injuries.

Commenting on the partnership with Monash, IHL CEO Joel Latham said using well-recognised animal study will allow the company to accelerate its development pathway as it moves towards pivotal clinical trials required by the US FDA.

“Furthermore, the company will collect additional data from an animal study that it would not be able to compile in human studies,” Latham said.

“This additional data will inform the design and end points of our pivotal clinical trials.”

The IHL-216A treatment combines cannabidiol (CBD) with an anaesthetic agent to help reduce trauma and inflammation from head injuries.

As part of the Monash Trauma Group study, the team will test the effectiveness of IHL-216A against isolated agents including CBD and isoflurane.

Previous studies indicated that IHL-216A outperformed CBD in reducing neuronal damage in post-mortem Nissl staining analysis of brain tissue by 53% for CA1 and 60% for CA2 in the hippocampal region of the brain.

Using the model developed by the NFL, the study will replicate the collision mechanics of sports-related concussions, scaled at a level for lab rodents.

The new study has been designed in accordance with Good Laboratory Practices, and a successful result will allow IHL to move straight to Stage 2 clinical trials, the company said.

The Monash Trauma Group comprises a leading team of scientists with different specialities, researching advanced solutions for different trauma-related conditions.

A key focus for the group is the prevention and treatment of traumatic brain injury (TBI), using both animal model and patient studies.

The IHL-216A study will be led by Dr Stuart McDonald, an expert in fluid biomarker development for monitoring TBI.

Due to its potential use-case in elite sport, IHL-216A has been designed to satisfy World Anti-Doping Authority (WADA) and Australian Anti-Doping Authority’s (ASADA) specifications for use by athletes at risk of high-impact brain injuries.

Incannex has also filed an International Patent Application entitled “Compositions and methods for the treatment or prevention of traumatic brain injury” as part of the IHL-216A development program.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

The post Incannex teams up with Monash University and the NFL in exciting new study for its proprietary concussion treatment appeared first on Stockhead.