Research & Development

Consumer Healthcare

Consumer Healthcare

The development pathway of plant-derived medicinal products all have similar origins, and much of the initial work is the same regardless if the product is intended for use as a cosmeceutical, nutraceutical, or prescription-only botanical drug.  Additionally, products that are initially developed for the consumer and personal healthcare market may subsequently be investigated as a prescription-only botanical drug after filing of an IND with the shorter, less onerous route to market.  Phynova is developing a number of products in the consumer healthcare sector.  The products are all plants extracts from medicinal plants, and will be targeted at various markets worldwide.

(Amended from: Schmidt et al., 2007. Revisiting the ancient concept of botanical therapeutics. Nature Chemical Biology, 3(7): 360-366.)

Traditional Herbal Medicinal Products
The European market for herbal supplements and herbal medicines is currently estimated to be worth US$ 7.4 billion. However, under the new EU Traditional Herbal Medicinal Product Directive (THMPD), Directive 2004/24/EC, by April 2011 many of these products will no longer be able to be sold.  After April 2011, no industrially produced herbal product may remain on the market unless it has been registered or licensed. 

Registration of THMPs has many advantages, foremost is the ability to add label-claims to the product.  Previously, herbal product manufacturers could only list the ingredients/plant name from which the product was made, thereby being reliant upon consumer awareness as to the indication it was intended to treat.  Through the THMPD, these products will be sold alongside traditional over-the-counter (OTC) medicines and will be able to make similar indication and efficacy claims. 

Phynova has identified a significant opportunity to launch a range of registered traditional Chinese herbal products that will not only help fill the gap that will be created in the market by the removal of most TCM products in 2011, but also offer an appealing alternative to the few registered Western herbs that have currently been registered.  TCM is arguably the oldest and most famous traditional herbal medicine system in the world, and with the ability to add label claims to THMPs, the marketing opportunities are considerable.

Phynova is developing products across a number of OTC indications including colds and flu; stress, fatigue, joint care, pain relief, diarrhoea, and women’s health.  These THMP products are being developed primarily for the European market.

Relivergen™
Relivergen™ is a patented combination of Salvia miltiorrhiza, Astragalus membranaceous, Schisandra chinensis, and Silybum marianum, plants well known for their detoxifying activity on the liver. Poor diet, excessive alcohol, and a number of chronic conditions place a high level of stress on the liver that may lead to complications such as fatty liver disease, steatohepatitis and cirrhosis. Relivergen™ targets multiple aspects of liver health with its antioxidant, anti-inflammatory and anti-fibrotic activities.

Clinical Studies
Clinical studies have shown that Relivergen™ effectively lowers the levels of liver enzymes associated with liver inflammation. Relivergen™ not only reduced liver inflammation in chronic hepatitis C patients, but also improved their health-related quality of life (QoL), as measured with the validated QoL instrument, the SF-36.



Two clinical studies have shown that Relivergen™ has an excellent safety profile and is well tolerated.


IminoNorm™
IminoNorm™ is a novel extract from a medicinal plant that is widely used across Asia for the treatment of prediabetes and mild type-2 diabetes. In vitro and in vivo studies have shown that it acts on several different biochemical pathways implicated in glucose control and potently reduces blood glucose levels after eating. By consuming IminoNorm™ the rate of carbohydrate metabolism is significantly reduced, lowering the glycaemic index of starch and sugar rich foods.

Data
IminoNorm™ inhibits several enzymes responsible for the digestion of carbohydrates, as well as reducing blood-glucose output from other sources.



In vivo data shows that oral administration of IminoNorm™ significantly lowers blood-glucose levels, with a dose of 50mg/kg being as effective as the positive control. A small clinical trial confirmed the in vivo data and a 400mg dose reduced post-prandial blood glucose by 53%.



Formulation
IminoNorm™ is readily soluble in water and may be made into tablets and capsules, or incorporated as an active ingredient in food supplements or health drinks. When combined with starch or sugar rich foods, the calorific content may be significantly reduced.


Fatigfix
Adaptogenic Plants
Adaptogens are plants that reduce stress, fatigue, trauma and anxiety and are often rich in anti-inflammatory and antioxidant compounds. FatigFix™ is a novel combination of three potent adaptogens that have powerful antioxidant activity.

Clinical Data
FatigFix™ was evaluated in a double blind, placebo-controlled study in 120 middle aged individuals (50-65 years) suffering from the symptoms of fatigue over a three-week period. Measures of fatigue and sleep quality were assessed through self-assessment questionnaires.

The study found that there was a significant improvement in five key fatigue factors, and an improving trend in 11 others. There was a significant improvement in quality of sleep, with subjects reporting sounder sleep, greater ease at falling asleep, and lower anxiety before falling asleep.There were no side effects and no differences in clinical biochemistry between the FatigFix™ and placebo groups.



Formulation
FatigFix™ is readily soluble in water and may be made into tablets and capsules, or incorporated as an active ingredient in energy drinks.