{"id":3473,"date":"2023-08-29T03:07:40","date_gmt":"2023-08-29T03:07:40","guid":{"rendered":"https:\/\/www.incannex.com\/?p=3473"},"modified":"2023-08-29T03:13:57","modified_gmt":"2023-08-29T03:13:57","slug":"https-smallcaps-com-au-incannex-healthcare-fda-clearance-ihl-42x-clinical-trial-obstructive-sleep-apnoea","status":"publish","type":"post","link":"https:\/\/www.incannex.com\/https-smallcaps-com-au-incannex-healthcare-fda-clearance-ihl-42x-clinical-trial-obstructive-sleep-apnoea\/","title":{"rendered":"FDA clearance to start IHL-42X clinical trial with OSA patients"},"content":{"rendered":"

Clinical-stage pharmaceutical company\u00a0Incannex Healthcare (ASX: IHL)<\/a>\u00a0has received approval from the US Food and Drug Administration (FDA) to conduct an investigational new drug (IND) opening trial for lead candidate IHL-42X in the US.<\/p>\n

The pivotal Phase 2\/3 trial will assess the effect of IHL-42X in obstructive sleep apnoea (OSA) patients who are non-compliant, intolerant or nai\u0308ve to positive airway pressure treatment, such as that administered by CPAP (continuous positive airway pressure) devices.<\/p>\n

It has been deemed safe to proceed following the FDA\u2019s assessment of the trial protocol, lead trial investigators and a risk benefit analysis of the trial and prospective product.<\/p>\n

Incannex is continuing preparations for the trial\u2019s start-up process which includes finalisation of institutional review board (IRB) applications and submissions for lead clinical trial sites.<\/p>\n

Site selection, approvals and IRB submission for additional study sites will be conducted at the same time.<\/p>\n

Synergistic combination<\/h2>\n

IHL-42X is a synergistic composition of dronabinol (a synthetic form of tetrahydrocannabinol (THC) and acetazolamide (a carbonic anhydrase inhibitor).<\/p>\n

Participants in the Phase 2\/3 trial will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial.<\/p>\n

They will complete daily surveys on their sleep quality; and attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy.<\/p>\n

Every three months, overnight polysomnography will be conducted to determine the effect of treatment on the patients\u2019 apnoea hypopnea index (AHI) along with a range of other sleep parameters.<\/p>\n

All drug treatments will be compared to placebo.<\/p>\n

Concept trial<\/h2>\n

Results from a Phase 2 proof of concept clinical trial by Incannex were released last year and found that the drug reduced patient AHI by an average of 50.7% versus baseline assessments, with 25% of participants experiencing a reduction of more than 80%.<\/p>\n

No serious adverse events were reported during the trial.<\/p>\n

Most common disorder<\/h2>\n

OSA is the most common of all sleep-related breathing disorders.<\/p>\n

It involves the narrowing of the upper airway during sleep, interfering with a person\u2019s breathing, decreasing oxygen uptake and resulting in poor-quality sleep.<\/p>\n

Untreated OSA can lead to serious long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk of accidents.<\/p>\n

There are no pharmacotherapy (drug) treatments available to those afflicted.<\/p>\n

Incannex said it expected \u201cgreatly improved treatment compliance\u201d and outcomes for OSA patients from a pharmaceutical product such as IHL-42X.<\/p>\n

Article credit: SmallCaps | By Imelda Cotton – August 24, 2023<\/p>\n","protected":false},"excerpt":{"rendered":"

Incannex Healthcare (ASX: IHL)\u00a0has received approval from the US Food and Drug Administration (FDA) to conduct an investigational new drug (IND) opening trial for lead candidate IHL-42X in the US.<\/p>\n","protected":false},"author":3,"featured_media":3469,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":0,"footnotes":""},"categories":[1,6],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts\/3473"}],"collection":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/comments?post=3473"}],"version-history":[{"count":2,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts\/3473\/revisions"}],"predecessor-version":[{"id":3476,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/posts\/3473\/revisions\/3476"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/media\/3469"}],"wp:attachment":[{"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/media?parent=3473"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/categories?post=3473"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.incannex.com\/wp-json\/wp\/v2\/tags?post=3473"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}