It’s been a crazy few days for invex. Up +50% with a positive announcement. Then today down +50% and currently at negative EV (5-6m)

today’s announcement

Update on IIH EVOLVE Phase III Clinical Trial & Initiation of an Independent IIH Market Assessment

Key Points:

• Lower than expected enrolment trajectory for IIH EVOLVE Phase III trial, due to higher screening failures and slower site activations than expected

• Revisions to Phase III clinical trial design required to remedy current design bottlenecks to enrolment

• Invex to focus on improving patient enrolment with amendments to both key inclusion criteria and secondary endpoints

• In parallel, the Company will complete a detailed market assessment initiated to understand the risk of approved GLP-1 receptor agonists to Invex’s IIH market opportunity

• Anticipated cash balance to 30 June 2023 of approximately $22.6 million

Invex Receives European Orphan Drug Designation for Exenatide in Traumatic Brain Injury

The market liked this announcement up 50% today

asx announcement

Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of PresendinTM (sustained release Exenatide) for neurological conditions relating to raised intracranial pressure, today announces the granting of orphan drug designation (ODD) from the European Medicines Agency (EMA) for Exenatide in the treatment of moderate to severe Traumatic Brain Injury (TBI).

This is the second ODD for Exenatide in Europe, with Invex receiving an ODD for Idiopathic Intracranial Hypertension (IIH) in 2017, alongside an ODD from the US Food and Drug Administration (FDA), also for IIH.

The EMA provides a range of incentives in the European Union (EU) for medicines that have been granted an orphan designation, including ten years market exclusivity from the date of approval, clinical trial protocol assistance, access to the centralised authorisation procedure in Europe, and certain fee reductions.

TBI affects adult and paediatric population globally and remains one of the major cause of traumatic death and disability across all ages worldwide. Overall, 57,000 TBI-related deaths and 1.5 million hospitalisations occur every year in the European Union.i Management of intracranial pressure (ICP) elevation is considered critical in patients with moderate to severe TBI, however, at present, there are no EMA or FDA approved therapies specifically for the treatment of intracranial hypertension in this patient population.

Invex is currently investigating PresendinTM, a once per week, sub-cutaneous, sustained-release (SR) Exenatide microsphere formulation in a randomised, double-blind, placebo-controlled Phase III clinical trial (IIH EVOLVE) in 240 IIH patients across the globe. Invex believes PresendinTM will be able to reduce ICP in a number of conditions associated with elevated ICP, including moderate and severe traumatic brain injury.

Dr Thomas Duthy Executive Director of Invex said “Since we first discovered the potent ICP lowering effects of Exenatide in pre-clinical models and within our completed Phase II Pressure IIH trial, the Company has explored other elevated intracranial pressure disorders, including TBI. Securing a European ODD for Exenatide is an important initial step in protecting the commercial opportunity in moderate to severe TBI, which is forecast to represent an annual market opportunity of US$2.45billion by 2027, growing 9% per annum

Quarterly call:

$25.4m cash

1st patient recruited Nov22, 5 sites activated. Should accelerate now post Christmas shutdowns.

But looking at 2 years before results are available >> 2 years recruitment + 24 weeks trial + assessment of data > 2025

no mid-way readout as would be penalised statistically and so would then need more patients

Pediatric trial can go ahead only if adult P3 trial is a success

Hello!

Thanks to all the former contributors - good reading!

Has anyone tried to model this themselves? What gross margin assumptions are you using / overheads moving forward / rate of penetration. And does anyone know the assumptions behind the $1.6bn TAM?

Thanks

Invex Therapeutics (ASX:IXC) receives FDA approval for third-phase Presendin clinical trial

• Invex Therapeutics (IXC) receives regulatory approval in the US to launch a phase three trial of its Presendin product for the treatment of idiopathic intracranial hypertension (IIH)
• Alongside the trial approval, the US Food and Drug Administration (FDA) granted Invex Investigational New Drug status for Presendin
• The company says it now intends to open a few clinical sites across the US to support the trial
• Invex also announces its 2022 financial year full-year results, flagging an increased loss after tax to $3.95 million compared to its $2.3 million loss over the 2021 financial year
• Shares in Invex are up 14.29 per cent to 64 cents at 11:29 am AEST

Invex Therapeutics (IXC) has received regulatory approval in the US to launch a phase three trial of its Presendin product for the treatment of idiopathic intracranial hypertension (IIH)

Alongside the approval for the IIH EVOLVE trial, the US Food and Drug Administration (FDA) granted Invex Investigational New Drug status for Presendin.

The trial will be a randomised, placebo-controlled, double-blind trial for 240 patients with newly-diagnosed IIH to determine the efficacy and safety of Presendin versus the placebo, administered once weekly over 24 weeks.

The trial aims to change intracranial pressure in the patients, with a secondary outcome of improving vision and headaches.

Invex Executive Director and Chief Scientific Officer Alex Sinclair said she anticipated a positive efficacy outcome from the study, which would facilitate further discussions with the FDA on the future registration requirements of Presendin.

Professor Michael Wall, the Steering IIH EVOLVE trial group Chairperson, echoed Professor Sinclair’s sentiments in his comments.

“A high calibre randomised controlled clinical trial such as IIH EVOLVE will answer many important clinical questions and better direct IIH patient care leading to potentially the first-ever drug approval for IIH,” Mr Wall said.

“Our team is looking forward to assisting Invex in the management of this important clinical trial.”

The biopharmaceutical company intends to open a few clinical sites across the US to support the trial.

Patients with IIH suffer from severely raised intracranial pressure which causes headaches and can compress the optic nerve. It’s most common in women who are obese.

Further to the FDA trial approval, Invex today released its annual financial report for the 2022 financial year.

In the report, the company flagged an increased loss after tax to $3.95 million compared to its $2.3 million loss over the 2021 financial year.

Source: Market Herald.

12 July. MST Access maintains a valuation of $3.38.

Full March Report

You Tube;  Presentation to Broker Briefing 24th March 2022

https://www.youtube.com/watch?v=x9B6IxaAVqI