Express Pharma

‘The grant award provides an important level of validation to our work’

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Botanisol, was awarded an NIH/ NCCIM grant to develop a new anti-inflammatory and possible Non-Steroidal Anti-Inflammatory Drug (NSAID) replacement. P Scott Waterhouse, Chief Executive Officer, Botanisol LLC reveals more to Sachin Jagdale

Botanisol has received NIH/NCCIM grant. What is the eligibility criteria for this grant?

20150930ep14The grant is a competitive award under the US Federal Government’s STTR (Small Business Technology Transfer) Program. The purpose is stated as: “STTR’s most important role is to bridge the gap between performance of basic science and commercialisation of resulting innovations.”

More details about the programme can be found at the following link: https://www.sbir.gov/about/about-stt

All applications go through a comprehensive scientific review by leading scientists and must demonstrate strong commercial viability. In our case, the application was submitted in early December 2014 with notice of the award on August 10. It is a lengthy, detailed and thorough process. Only US citizens, majority-owned business is eligible for an award. At least 30 per cent of the work must be done in a research institution and at least 40 per cent must be done by the company in company-controlled facilities.

Besides NIH/NCCIM, do you have any other funding options?

At this time, Botanisol is funded by its founders, as well as a small investment by a venture-focused law firm. We are currently seeking investment capital and/or strategic partnerships. The grant award provides an important level of validation to our work and plans that will aid in successfully raising funds. According to our plan, less that $1 million will fund the development needed to get a product to human clinical trials. We believe our research plan will lead to variants of the original compound with other, specific anti-inflammatory properties. In this case, our programme will likely expand beyond the initial discovery and require more funding. We are pursuing this as a regulated, ethical, OTC (US FDA approved) drug candidate. However, it probably qualifies as a dietary supplement (nutraceutical) which could reach the market fairly quickly and at relatively low cost.

What benefits would TAI-LCx offer over NSAIDs? Could you explain its exact mode of action?

One of the three areas that we will explore with the HIH Grant is the various modes of action for our TAI-LCx compound (and promising variants). The original research/ discovery showed that it works by mediating TNF-alpha, PGE2 and IL-6 but does not affect COX2. Our scientists believe that it does not affect COX1, however, will be determined in the grant funded research. The research will assay for other anti-inflammatory activity and should provide a fairly complete picture. We also expect to measure anti-inflammatory response against some existing medications. The original research showed TAI-LCx to be equivalent to or more effective than indomethacin but with a better safety profile. All NSAIDs mediate COX 1 and/or COX 2. The interference with COX expression is the cause of the serious adverse affects from NSAID use which include cardiovascular (due to COX 2 mediation) and gastrointestinal, liver and renal due to (COX 1 mediation). The need for a better drug to treat acute pain has been well documented and known at least since about 2001 with the deaths caused by the Coxhibs (Bextra, Vioxx and Celebrex). It is an area of major interest to the global pharmaceuticals industry.

When is TAI-LCx expected to get commercialised?

Our business model is to take the discovery along the pre-clinical development stages and partner with or license to a larger company for clinical trials and final product development. This should occur soon, certainly within the next 18 months. The timeline for (human) clinical trials and regulatory approval is difficult to forecast and best addressed by firms that specialise in the process. If someone were to take TAI-LCx to the market as a nutraceutical or ingredient, I think they could have something substantial on the market within two years or less. US FDA regulations do not allow for drug development of compounds that are sold as dietary supplements so simultaneous development of the same compound for both markets is not possible.

Is anti-inflammatory the only focus area for your company?

Botanisol provides safer, more affordable medicines to the pipelines of large healthcare companies by applying modern science to known bioactive constituents of plants.

Till now, how much investment has gone into developing TAI-LCx? What is the expected investment till this molecule gets commercialised?

I prefer at this time not to publicly disclose the total investment. The original discovery was funded by NIH under a multiple year programme that totalled $6.8 million. It is not our business model to take drugs candidates all the way through regulatory approval and to commercialisation.

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