To mark its 10th anniversary, Drug Discovery & Development magazine invited pharmaceutical and biotechnology companies to reflect on the history and made predictions about future of the industry. Featured here are verbatim comments from this company.

Sirtris, a GSK company

Headquarters 
Cambridge, Mass.

Years in Drug Research 
4 years

Spokesperson
Christoph Westphal, M.D., Ph.D., Chief Executive Officer

Web site 

About the company/organization
At Sirtris we’re focused on discovering and developing proprietary, orally available, small molecule drugs with the potential to treat diseases associated with aging, including metabolic diseases such as Type 2 Diabetes. Our drug candidates are designed to mimic certain beneficial health effects of calorie restriction, without requiring a change in eating habits, by activation of sirtuins, a recently discovered class of enzymes that we believe controls the aging process.

Our most advanced clinical programs are focused on developing SIRT1 activators, such as SIRT501, our proprietary formulation of resveratrol, to treat Type 2 Diabetes and mitochondrial disorders such as MELAS. In addition, we’ve launched a Phase 1a clinical trial for SRT2140, one of our promising new chemical entity (NCE) SIRT1 activators, which are structurally unrelated to and up to 1,000 times more potent than resveratrol.

A 10-year perspective: Advances and roadblocks
Founded in 2004, Sirtris was one of the first pharmaceutical companies focused on sirtuins. Preclinical studies demonstrated potential therapeutic benefits of SIRT1 activators in multiple disease areas, including Type 2 Diabetes, mitochondrial disorders, cardiovascular disease, inflammation, neurodegenerative diseases, and cancer. Earlier this year, Sirtris announced promising results of a Phase 1 Type 2 Diabetes trial, in which the drug lowered patients’ glucose levels. While SIRT1 was the first in this family of enzymes to be discovered, considerable research is also underway for other members in the sirtuin family, SIRTs 2-7.

We’ve made great strides since our inception four years ago. The excitement about the science of sirtuins enabled Sirtris’ successful IPO in May 2007. On June 5, 2008, GlaxoSmithKline acquired Sirtris at a 125% premium to Sirtris’s IPO, further validating our technology and accelerating our path toward FDA review and approval.

R&D Challenges in the next 10 years
The biggest challenge for any biotech or pharma company in R&D is one of resources, especially in the current financing environment. Sirtris is fortunate that with the GSK acquisition, we have extensive, additional resources with which to proceed with our current and planned discovery programs and clinical trials of our proprietary sirtuin activators in a broad range of diseases of aging.

We see tremendous opportunities for targeting SIRT1 and the other members in this class of enzymes. Just last year, a study by Sirtris Scientific Advisory Board members and Harvard University scientists published in the journal Cell showed for the first time that activation of SIRT3 and SIRT4 protects against cell damage, which has implications for altering metabolism and treating diseases of aging. By continuing our research into the other members of the sirtuin family, we’re expanding the potential of our drug discovery platform.

Business/regulatory challenges for the next 10 years
As we advance our clinical development efforts toward regulatory submission over the next several years, the challenge will be continuing to design and implement meaningful trial designs that will influence several of the major health crises we face as a society. Specifically, our product candidates may address metabolic disorders like Type 2 Diabetes and Obesity, and other diseases of aging like Alzheimer’s disease and cancer. Here, again, we are fortunate to have GSK’s incredible resources and breadth of experience at our fingertips. We’ll be able to leverage GSK’s expertise in submitting a new drug application and managing the FDA approval process. In addition, having GSK’s marketing and sales resources will translate to a more widespread impact in treating people affected by metabolic diseases and diseases of aging — enabling us to do more, feel better and live longer.

Bold Prediction: Where will the company/organization be in 10 years?
The GSK acquisition of Sirtris has helped fast-track our ability to advance our science. With GSK’s large resources, we can potentially proceed with clinical trials at an expedited pace, meaning that it’s much more likely that one of our drugs in development will be available within the next decade.

Bold Prediction: Where will the industry will be in 10 years?
As big pharma pipelines have dried up, there’s been an intensifying focus on biotech discoveries. We’ll see the industry continue to move toward an improved acquisition model—exemplified by GSK/Sirtris—where research-driven biotech companies will operate autonomously and maintain their entrepreneurial culture, while leveraging the development/commercial expertise of big pharma.