EGFR-inhibitors have been used to treat cancer in millions of patients worldwide
A class effect in neuropathic pain - striking effects reported by 70% of patients treated.
EGFR-inhibitors do not have sedative side effects and are not addictive.
A well established drug class in oncology, but with novel mode of action against pain.
Pain relief already documented in >100 patients treated with EGFR-inhibitors at 10 clinics.
The Two Routes of Administration
Several EGFR-inhibitors are approved for treatment of various cancers. These include monoclonal antibodies for intravenous use and tyrosine kinase inhibitors which come as oral tablets.
AKIGAI’s mission is clear and stedfast:
“To make an EGFR-inhibitor available to as many neuropathic pain patients as possible, as quickly as possible.”
To this end, we have mapped all marketed EGFR-inhibitors and >60 development candidates that have been tested in clinical trials.
After in-silico research, experiments in rodent models, as well as years of observations in 100+ successfully treated neuropathic pain patients with 11 different pain entities, one of the EGFR-inhibitors approved for the treatment of cancer stands out.
- Tyrosine kinase inhibitors
given as tablets
EGFR-inhibitors in tablet form are preferable for most cases of neuropathic pain and CRPS.
We will therefore repurpose AKI-007 tablets for the treatment of neuropathic pain. The rare disease Complex Regional Pain Syndrome (CRPS) is widely regarded as one of the most severe and debilitating pain conditions. To date, no drug has ever received FDA or EMA approval for this indication. However, we have seen frequent, dramatic and sustained effects from EGFR-inhibitors in CRPS patients. Our development candidate (AKI-007) has been granted orphan drug designation by both the FDA and EMA, reinforcing the promise of our approach.
AKIGAI is currently preparing for a Phase III clinical trial in CRPS.
As a rare disease in chronic patients, CRPS is a perfect stepping stone to entering the neuropathic pain market and will be followed by other neuropathic pain indications.
AKI-007 will relief many patients from neuropathic pain. This is not a hypothesis, but an obligation we have embarked on to fulfill.
- Monoclonal antibodies
for parenteral use
A hypothesis we have, however, is that even AKI-007 can be improved upon by a targeted and adaptive monoclonal antibody against the EGFR. This antibody will take longer to reach the patients, but it may have even stronger efficacy, reduced toxicity and improved bioavailability.
This form of administration may also be preferred in patients with acute or transient pain and among patients who cannot swallow/absorb tablets. Examples of these pain entities are cancer-related neuropathic pain, post-traumatic and post-operative neuropathic pain.
Repurposing vs de
novo drug development
Conventional drug development is risky, time consuming and thus costly. In certain situations, drug repurposing can be advantageous.
Drug repurposing is the use of existing drugs for new therapeutic purposes. Thus, it reduces the time, risk and costs of drug development. In Europe the term of «Value added medicines» has been used: Value added medicines – homepage | Medicines for Europe.
AKIGAI has matched its clinical and biological insight with scrutinized screening efforts to determine certain EGFR inhibitors for repurposing. This will advance our aim to make less toxic and more effective EGFR inhibitors available as fast as possible for as many neuropathic pain patients as possible.
Repurposing is underutilized due to unfortunate market protection mechanisms for certain drugs in certain situations and for certain drug owners. AKIGAI has thoroughly evaluated different options and created four layers of market protection mechanisms around our 1st generation EGFR inhibitor for the treatment of neuropathic pain.