Opportunities for Pharma Co’s

AKL is conducting a Phase I study, followed by a Phase II pivotal OA clinical trial in the UK.

In AKL4 (aka APPA) we see value opportunities driven from 4 distinct areas: commercial, patient, clinical and payer.

AKL is open to discussing post proof of concept collaboration and partnering opportunities.

Commercial

The global market for OA has been estimated at 1-2.5% of GDP for the USA, Canada, UK, France and Australia.

We anticipate this market will grow due primarily to the ageing population and increasing rates of obesity.

Not only is the burden of disease high but the burden of treatment with currently available options is also high.

Recent guidance (UK regulatory agency MHRA, NICE and American Congress of Rheumatology) has determined that paracetamol is ineffective in OA, and nutritional supplements of glucosamine and chondroitin offer no benefit over placebo.

APPAs efficacy and tolerability profile suggest it could be used as a first line therapeutic option (following self-medication) instead of topical / oral NSAIDs, particularly in those patients who have, or at risk of, CV, GI or liver toxicity. In addition NSAIDs are contra indicated for patients receiving anti coagulation therapy.

We anticipate APPA will be differentiated primarily by its tolerability. In addition APPA has the potential for disease modification.

Other therapeutic options in development are targeted at advance disease.

Patient

The unmet medical need is high.

The burden of treatment is high.

Patient acceptance of an oral treatment is high.

Clinical

in vivo animal models of OA have demonstrated that APPA relieves pain and limits cartilage degeneration in arthritic joints, and is well tolerated.

Producing drug-combinations against multiple disease targets in OA is an appropriate approach. Although targeted therapies may offer enhanced efficacy and improved selectivity (and therefore less toxicity), most often their effects are not durable when they are used alone as cellular pathways operate more like webs than superhighways. There are multiple redundancies, or alternate routes, that may be activated in response to the inhibition of a single pathway. Single drug therapeutics are rarely able to fully address the complex nature of OA.

APPA offers a multimodal MOA, it inhibits ROS overexpression and downregulates NFKB activation, nuclear translocation, and DNA binding, allowing a multimodal NFKB moderator activity that does not cause profound inhibition.

These evidence based findings indicate that APPA has the potential to represent a unique OA drug profile.

Payer

Tolerability concerns of NSAIDs lead current UK and US guidance to prescribe NSAIDs where required at the lowest dose and for the shortest duration providing opportunity for an effective, well tolerated drug that can be used in a chronic setting.