Incannex Healthcare [ASX:IHL], the medical cannabis and psychedelic drug developer, released an update about a cGMP-grade psilocybin drug product it will create with a drug company, Catalent.
Catalent is a technology, drug, and biologic company located in New Jersey— it will work closely with Incannex for the development of IHL’s psilocybin drug for anxiety treatment.
The IHL share price was trading for as little as 13 cents after taking a drop of over 7% to the last closing price.
Inncanex’s stock is now down 62% in the year and 28% in the last month alone:
Source: tradingview.com
Incannex to develop anxiety drug with Catalent
In teaming up with Catalent, Incannex’s idea is to create a cGMP-grade psilocybin drug product for generalised anxiety disorder, one that can be produced on a commercial scale as a cGMP pharmaceutical-grade product.
Intended as an extension of Incannex’s existing psilocybin drug, the new product will be used in IHL’s psilocybin-assisted psychotherapy drug development program.
After successful interim analysis of interim data from the PSiGAD phase 2 clinical trial, IHL now has the confidence to begin development and manufacturing processes with the US company.
Incannex said that the interim results from the PsiGAD trial will remain internal and confidential to avoid compromising the trial but hinted at a report from the independent data safety monitor board (DSMB), which is soon to be released.
Joel Latham, Incannex’s CEO and Managing Director commented:
‘Having our own source of pharmaceutical grade psilocybin not only allows our company to freely undertake clinical trials, it also creates and assists with number of commercial opportunities which are currently at an advanced stage of investigation by the company, and will be announced in the coming weeks, following board appraisal and approval.’
Catalent’s role will be to develop formulation and generation quality and create stability data for regulations, establishing the cGMP product for future clinical trials.
IHL said that it has already proposed designs with commercial supply levels in mind so that it can be scaled accordingly when the time comes.
Incannex believes the drug and all its paperwork will play an important role in future regulations. It will also assist Incannex in developing psilocybin-assisted psychotherapy for generalised anxiety disorder.
Aside from its anxiety drugs, Incannex is also developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep, brain injury, lung inflammation, rheumatoid arthritis, bowel disease, and addiction disorders, among others.
Though subject to continued clinical success, marketing approval and FDA registration are being pursued for each product and therapy.
The company has expressed that major global markets currently have little to no existing public registration of pharmacotherapy and drug treatments. This could mean patients may be able to take advantage of Government subsidies so long as products can achieve the desired regulatory steps in clinical trials.
On Tuesday, the biotech announced a successful Phase-1 trial for the treatment of rheumatoid arthritis, inflammatory lung conditions, and inflammatory bowel disease.
If Phase-2 of the clinical trial can prove satisfactory efficacy, safety, and tolerability in afflicted patients, the proprietary drug IHL-675A could lead to accessing a US$125 billion market.
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