If you’re interested in the bonafides of the company, then let’s start with IHL-42X. Facts are more important than fabricated conspiracy theories on Hot Copper.
The IND application was reviewed by US FDA, not Hot Copper posters, FDA. The IND dossier included comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients. It also included detailed information on the development, manufacturing, quality and stability of the IHL-42X drug product, as well as the clinical protocol and investigator information for the Phase 2/3 IND opening clinical trial.
Again, the IND was reviewed by FDA, not Hot Copper posters.
FDA completed their review of the IND package and Incannex received confirmation from that the IND opening study may proceed. And for those who attended one of the meetings with the company recently, as I did online, you’ll know that apparently Bob Clark made specific comments about the Incannex submission. Correct me if I misheard but the comment was something along the lines that in his career he’d never seen an IND submission from a company of IXHL’s size go through FDA with so few questions. He said it was a testament to the calibre of Incannex.
Incannex are now working with Fortrea, the CRO engaged to manage the Phase 2/3 clinical trial to prepare institutional review board applications for the lead trial sites, complete the selection and approval of the remaining trials sites, and further prepare for patient recruitment and dosing for the clinical trial.
Fortrea is a leading global Contract Research Organization providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations. It was spun off from Labcorp, which is a leading global life sciences company listed on NASDAQ with over 75,000 employees in 100 countries and revenue exceeding USD $16 billion.
The BA/BE clinical trial is being undertaken by CMAX Clinical Research and Novotech CRO and the study design adheres to FDA recommendations as it’s a component of the New Drug Application (NDA). Perhaps you’re spotting the pattern, IXHL is following FDA recommendations, not thought bubbles from posters on Hot Copper.
CMAX is one of Australia’s largest and most experienced clinical trial centres. It’s been operating for 23 years making it the longest running CRO in Australian history.
Novotech is one of Australia’s largest CRO’s with experience in over 5,000 clinical projects, including Phase I-IV clinical trials and bioequivalence studies. Novotech operates in Asia Pacific, the US and Europe with over 3000 staff globally and 34 office locations.
Ethics approval for the BA/BE study was received in July 2023 from Bellberry HREC who were established in 2004. Bellberry is one of approximately 200 registered HREC’s in Australia and they must comply with the strict guidelines for clinical trials as set by the NHMRC. The Bellberry HREC’s are chaired by qualified medical experts and professors, none of which are Hot Copper posters.
In June 2023 Incannex appointed the lead principal investigators for the phase 2/3 clinical trial. Unfortunately no Hot Copper posters were appointed.
Dr John Hudson of FutureSearch Trials of Neurology, Austin, Texas is board certified in Neurology and Sleep Medicine. He serves as the Principal Investigator for FutureSearch Trials of Neurology.
Dr. Hudson has supervised over 300 clinical trials over the past 20 years mostly related to neurological and sleep disorders and has been a national and international speaker for these disorders. Dr. Hudson completed his neurology residency at the University of Iowa and was Austin’s first board certified sleep specialist. Past activities include founding the Austin Neurological Clinic and Sleep Medicine Consultants. He held the position of President of the Texas Neurological Society, with a Lifetime Achievement Award and President of the Capital Area American Heart Association. FutureSearch Trials consists of two clinical research facilities in Austin and Dallas, Texas which have been in operation for over 15 years. The Austin site where Dr. Hudson is the Principal Investigator focuses on clinical research studies for treatment of neurological, pain and sleep disorders and features an on-site sleep lab.
Regarding the IHL-42X trial, Dr Hudson said: “Clinical trials for novel formulations of medication are newsworthy for any specialty and sleep medicine is no exception. Obstructive Sleep Apnea, affecting millions of people, remains under treated. This is due in part to patients not being diagnosed, and in part due to poor patient compliance with current therapeutic modalities. While unheard of a few years ago, oral medications to help reduce the cause of OSA, are now undergoing further investigation. This is more than exciting, it could prove to be life-changing for many patients.”
Dr Russell Rosenberg, of Neurotrials Research Inc, Atlanta Georgia is currently Chief Science Officer and CEO of NeuroTrials Research in Atlanta. Dr. Rosenberg, a native of St. Louis, obtained his doctorate in clinical and research psychology from The Ohio State University and received specialized training in sleep disorders medicine and research at Rush Presbyterian - St. Luke's Medical Center in Chicago.
He has more than 35 years’ experience in clinical sleep medicine and research, acting as an investigator in over 300 clinical trials including 14 in OSA and 211 in other sleep related disorders. He is a Board-Certified Sleep Specialist and Fellow of the American Academy of Sleep Medicine. Dr. Rosenberg is former Chair and spokesperson for the National Sleep Foundation (NSF) and has appeared frequently on local and national television news shows including the Today Show, Good Morning America, CNN, and MSNBC. Neurotrials Research Inc is a clinical research facility in Atlanta, Georgia that has been in operation for over 25 years. Neurotrials Research is focused on delivery of trials in neurology/CNS and sleep indications.
Dr Rosenberg said: “Incannex has developed a sound, rational, scientific protocol to determine the efficacy and safety of IHL-42X in subjects with obstructive sleep apnea." "Many sleep apnea patients cannot adhere to positive airway pressure therapy, use it for an inadequate period at night or just refuse it. Having a safe, effective pharmacological option for obstructive sleep apnea will be a positive addition to the treatment landscape as it will offer those that struggle to adhere to positive airway pressure therapy an alternative therapy.”
And expanding on my earlier comment about Robert Clark, who is currently the Vice President of Regulatory Affairs for Novo Nordisk in the United States. He joined NN in 2012 after spending over 20 years at Pfizer in roles of increasing responsibility in the regulatory field. Robert has over 35 years of US and global regulatory experience. Under his leadership, his regulatory teams have received US FDA approvals for a large number of medicines across various therapeutic areas.
Bob Clark has never seen the value in seeking a second opinion from posters on Hot Copper.
And by the way, Novo Nordisk is one of the oldest, largest and most respected pharmaceutical companies in the world. It has a market capitilization of US $410 billion, exceeding the GDP of its entire domestic economy in 2023.
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