Chemotherapy-Induced Peripheral Neuropathy (CIPN) has always been an iceberg in the ocean of cancer care. Underestimated and heavily consequential. AlgoTherapeutix, an innovative Paris based biotech focused on complex pain may well melt the iceberg.
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is an underestimated and devastating condition. Experienced by over 60 per cent of patients undergoing chemotherapy treatments, it ranks among the leading causes of chemotherapy modification or interruption, and is a cause of intense pain for patients.
A form of nerve damage to the skin of patients’ hands and feet, CIPN is most commonly associated with chemotherapies including platinum drugs, taxanes, vinca alkaloids (plant based drugs which block cell growth), proteasome inhibitors (drugs which prevent the degradation of protein within cells) and thalidomide derivatives used to stop cancer cells from developing).
The nerve damage caused by these chemotherapies produces symptoms which include burning, electric and stabbing sensations, numbness, tingling and allodynia – a condition which causes intense pain caused by normally painless stimuli.
Currently no FDA-approved therapy for CIPN exists. Despite the best efforts from their consultants, patients suffering from this crippling condition, have to endure severe pain and a reduced quality of life. “The debilitating pain which CIPN inflicts is not the only cause for concern. The condition often leads to chemotherapy dose reduction or termination, which may increase the chances of cancer-related morbidity and mortality,” explains Stéphane Thiroloix, CEO and Founder of AlgoTherapeutix.
To reduce the pain of the condition, clinicians will generally administer oral antidepressants and anticonvulsants. Whilst these yield some pain relief, they are limited and trigger taxing cardiovascular, neurological and neuromuscular side-effects. Indeed, reaching the right concentration in the skin requires the administration of high oral doses which in turn cause unwanted side-effects.
Developing a novel solution
It is therefore logical to look for an active compound with strong peripheral activity that can be administered directly into the skin with minimal passage in the bloodstream and therefore cause minimal systemic side-effects. A few attempts occurred to design a topical presentation of amitriptyline – indeed amitriptyline’s activity has a strong peripheral activity. Those attempts failed and the scientific community since then considered that amitriptyline is too complex to formulate for topical administration, probably difficult to protect with solid Intellectual Property, and possibly exposed to pricing challenges once approved.
In 2018 AlgoTherapeutix, led by pharma veterans Stéphane Thiroloix (CEO) and Olivier Bohuon, commenced development of their own revolutionary treatment to relieve patients of the pain experienced by CIPN – ATX01. The distinctive concept behind this new treatment being that through targeting the epidermis and dermis – the outermost layers of skin and predominantly the location of damaged nerve fibres with a high concentration amitriptyline gel, ATX01 will achieve strong efficacy. By contrast, its expected low systemic absorption will avoid the side-effects of oral treatment.
AlgoTherapeutix has now completed four vital stages of bringing ATX01 to market –
- Filing a solid patent portfolio;
- Applying formulation-by-design to develop a high-concentration formula with the intended penetration properties;
- Demonstrating the local activity of amitriptyline on the peripheral nervous system;
- Conducting a full pre-clinical plan which now makes ATX01 ready for testing on patients.
The innovative nature of ATX01 in revolutionising the administration of pain relief for chemotherapy and related treatments is undoubtedly due to the considerable knowledge and industry related experience of AlgoTherapeutix’ co-founders.
A start up with a difference
In contrast to the typical start-up, AlgoTherapeutix was founded by Stéphane Thiroloix and Olivier Bohuon, who are both pharma veterans. Stephane’s career journey has included prestigious roles at reputable R&D-based pharmaceutical corporates, including Executive Vice-President of Corporate Development at Ipsen – a leading biopharmaceutical group dedicated to improving lies through innovative medicines in oncology, neuroscience and rare diseases.
Equally, Olivier Bohuon has served as Chief Executive and Vice President for established global corporates within the pharmaceutical sector, including Smith & Nephew and Abbott Laboratories.
Backed by such illustrious expertise it is clear that AlgoTherapeutix’ innovative co-founders bring a wealth of top-to-bottom experience in the development, business development and commercialisation of pharmaceutical products.
Discussing this, Stéphane Thiroloix said, “Awareness of our limits is our main quality, and we have the ability to reach out to experts to go beyond these limits. We will now see ATX01 through its clinical development, with an aim of teaming up with suitable pharma partners for a 2025 commercial launch.”
From here, the door is open to exploring additional uses of ATX01, as its gel formulation and therefore simple method of administration may make it suitable for other forms of peripheral neuropathic pain.
This has been evidenced with the FDA recently granting AlgoTherapeutix an Orphan Drug Designation to study ATX01 in erythromelalgia – (Formally known as Mitchell’s Disease) – a rare and extremely painful disorder which causes severe burning pain and inflammation of the hands and feet.
“The ability to investigate ATX01 in erythromelalgia is an exciting medical pursuit as sufferers have very few options for pain relief. This provides us with opportunity to increase our understanding of ATX01’s activity on essential pain conduction mechanisms” states Stéphane.
Innovation can be measured on the dimensions of novelty and impact. Having challenged the consensus on CIPN and built a “silver start up” AlgoTherapeutix is likely to score highly on the impact scale when it brings genuine relief to millions of patients with CIPN and other forms of peripheral neuropathic pain.
Further information on Algo Therapeutix – this innovative Paris based biotech start up – updated progress on ATX01 can be found at http://algotx.com/