New study offers hope for dyspeptic horses

Australian natural therapy company, BioProspect (ASX: BPO) today announced the initiation of a major safety study on the use of Bioeffective A in horses as a natural health treatment.

The move follows encouraging results from a 2008 screening trial in the United Arab Emirates, which tested the natural compound’s efficacy as a treatment for Equine Gastric Ulcer Syndrome (EGUS). One of the horse industry’s most common gastric complaints, EGUS has been reported to affect up to 90 per cent of racehorses and causes poor performance and behavioural problems. All horses tested in last year’s trial at the Albidayer Stud in Sharjah showed improvement and regression of symptoms of EGUS following treatment with Bioeffective A, a galenical complex extracted from the green needles of Scotch Pine and Norwegian Spruce trees.

BioProspect’s CEO, Mr Peter May, said the new, larger study showed the Company’s confidence in the product’s potential as a natural and safe alternative for the international animal health market. “Following last year’s positive results in the UAE, we have now confirmed the market opportunity and also the regulatory pathway that will allow for the commercialisation of Bioeffective A in the Australian market by 2010, and ultimately in overseas markets,” Mr May said.

“The cost of the safety study is $200,000 and represents a major investment by BioProspect in commercialising the Bioeffectives range of natural products in animal health.” A specialist veterinary researcher in Sydney will undertake the safety study over a five-month period, involving the treatment of over 20 horses. The study’s stages will comprise ethics approval, acclimatisation and a three-month treatment period. Assessments will include regular examination by the supervising vet and blood testing before, during and after the treatment period to confirm no adverse effects.

“The standard protocol is for a maximum treatment of x5, but we are using x10 to demonstrate the exceptional safety aspects of this product,” Mr May said. “The horses tested in the previous study willingly took the product and appeared to actually like the taste, with no adverse or anaphylactic reactions.”

The safety study’s trial protocol is based on US Food & Drug Administration and VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of 2 Veterinary Medicinal Products) guidelines. VICH is a trilateral (European Union-Japan-US) program aimed at harmonising technical requirements for veterinary product registration.

“Use of the VICH guidelines should ensure the acceptance of this trial data across all major regulatory regimes, including the US and Europe,” Mr May said. “This will assist with the process of obtaining regulatory approvals in other countries as BioProspect progresses its market development activities with Bioeffectives.”

The safety study is part of the requirement to register the product under a Category 2 registration with Australia’s APVMA (Australian Pesticides & Veterinary Medicine Authority).

Data required under this category include product chemistry, efficacy and target animal safety. Toxicological data are generally not required for products such as Bioeffective A that contain active constituents that are contained in herbal products registered by the Therapeutic Goods Administration (TGA).

Bioeffective A (Conifer Green Needle Complex) is already listed by the TGA for use in complementary human medicine.

“The TGA listing for Bioeffective A reduces significantly the registration requirements for the product,” Mr May said. “We are hopeful that after the study’s completion, and submission with product chemistry and efficacy information, it will be approved for use in horses later in 2010.”

Meanwhile, BioProspect will continue investigating market opportunities in other countries and also progress plans to expand efficacy studies targeting EGUS and other conditions in horses.

“BioProspect is committed to targeting high value market segments where Bioeffectives can provide safe, natural and effective benefits in the treatment of a number of animal health conditions,” Mr May said. “Along with the horse segment, there are significant opportunities in food production animals such as poultry, pigs, dairy and beef cattle. The Company is focused on capturing these opportunities and developing sustainable products for the benefit of all stakeholders.”