Month: May 2021

Last week the US government announced it would begin granting growing approvals to several companies for medicinal marijuana research, ending an informal moratorium on licence issuing which has been in place since the Trump administration.

According to a press release from the founder and CEO of Biopharmaceutical Research, George Hodgin, the marijuana manufacturing approvals represent a “monumental step” forward for the American cannabis industry.

“This federal licence will forever change the trajectory of our business and the medicinal cannabis industry,” Biopharmaceutical Research George Hodgin said.

“The DEA’s leadership will set off a nationwide wave of innovative cannabis-derived treatments, unlock valuable intellectual property and create high quality American jobs.”

At the same time, it was also announced that the Minnesota state government had successfully passed a proposal to legalise recreational marijuana use. However, while the legislation’s passage through the House was largely expected, it faces a tougher time in the Republican-controlled Senate, which has historically demonstrated extreme reluctance to entertain the issue.

As a result, the outlook of the ‘Horizons Marijuana Life Sciences Index ETF’ (HMMJ) experienced a noticeable spike on the six-month performance chart on Friday—after flagging for much of the week — showing a gain of 24.4%.

Conversely, the performance of the Australian Cannabis Index spent the week in a state of ongoing decline before reaching a nadir of -11.9% by the week’s end, while the S&P 500 and Australia’s All Ordinaries both experienced minor dips followed by moderate rally.

The Australian pharmaceutical developer, Incannex Healthcare (ASX:IHL), announced last week that it had partnered with the University of Western Australia Centre for Sleep Science (UWA) to expand its ongoing investigative IHL-42X clinical trial to a multi-site study.

While the Obstructive Sleep Apnoea trial is currently being conducted at the Alfred Hospital in Melbourne, additional patient recruitment will now also be handled by the medical and scientific staff at UWA.

The move leaves the company well-positioned to pursue the next steps in its clinical development program, as an eventual application for FDA product registration will require multi-site patient examinations.

“We have been impressed with the academic credentials of the team at UWA CSS and their enthusiasm for the potential of IHL-42X as a treatment for OSA,” Incannex Healthcare Managing Director and CEO Joel Latham said.

“UWA CSS are also the only academic institution in Australia that has experience in conducting research on cannabinoids and sleep disorders.”

The Green Fund’s Australian Cannabis Index allows investors to benchmark top players in the Aussie cannabis space against the S&P500, the AORD, and HMMJ, giving them an overview of the health of the industry Down Under.

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The company has partnered with one of Australia’s leading sleep science research as the second test site for ongoing clinical trials.

 Clinical-stage cannabis and psychedelics company Incannex Healthcare (ASX:IHL) has taken another important step forward in the development of its proprietary IHL-42X treatment for obstructive sleep apnoea.

The company announced that it has commissioned University of Western Australia Centre for Sleep Science as an additional test site for IHL’s Phase 2b trials.

Testing at UWA will run in parallel with ongoing trials at The Alfred Hospital in Melbourne.

Importantly, the inclusion of UWA means the trial is now classified as a multi-site study with the input of additional medical and scientific experts.

“Our partnership with UWA puts us in good stead for the next steps in the IHL-42X development program, because pivotal studies necessary for FDA registration will require multi-site patient examinations,” IHL CEO Joel Latham explained.

Robust process

Obstructive Sleep Apnoea is a highly prevalent condition that affects around 30 million adults in the US each year alone.

In Australia, research from Deloitte Access Economics estimates that economic costs directly connected to OSA exceed $20bn each year.

A common symptom is high blood pressure, which can materially increase the risk of heart disease and cardiovascular morbidity.

As a result, Incannex’s IHL-42X drug benefits from an accelerated approval pathway as a treatment for an unmet medical need.

On that front, Latham said the team at UWA CSS bring high-level academic credentials and sector expertise to the development process.

“UWA CSS is the only academic institution in Australia that has experience in conducting research on cannabinoids and sleep disorders,” Latham said.

The University’s Centre for Sleep Science boasts world-class facilities dedicated to finding improved insights on sleep health, and results from its research are regularly published in international medical journals.

CSS director Jen Walsh is the principal investigator for no less than 10 sleep studies currently running, in conjunction with the sleep physiology research team at the West Australian Sleep Disorders Institute.

As a leading researcher in the field, Walsh said the CSS team is excited to partner with Incannex as it builds out a viable alternative treatment option in the field.

“Given the number of people with OSA and the proportion unable to tolerate existing therapies, it is exciting to be working with Incannex on this trial of an alternate treatment option,” Walsh said.

“Even patients who can tolerate existing therapies for their OSA would sometimes like the option to take a medication rather than sleep with a device.”

In that context, UWA’s involvement is a testament to the IHL management team’s ability to develop clinical studies with world-leading medical researchers as it executes on a multi-channel development pathway.

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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