As the RNAi-based therapeutics space becomes increasingly crowded, keeping track of who's doing what and when can prove a challenge. As such, RNAi News has compiled a list of the major players in the space and where their publicly stated clinical-development efforts stand.
For the most part, the timelines provided are unchanged from those provided by the companies in recent months. There are a few exceptions, however.
The biggest shift occurred at Sirna Therapeutics, which just streamlined its pipeline in a bid to control costs. While Sirna had given estimates on six drug programs in January (see RNAi News, 1/14/2005), the company recently said it was focusing on its three core programs • in hepatitis C, age-related macular degeneration, and permanent hair removal • and other projects would only be "advanced with a combination of internal and external support" (see RNAi News, 5/13/2005).
A surprise came from Acuity Pharmaceuticals, which, after being the first company to get an RNAi drug into humans (see RNAi News, 11/12/2004), is already looking to the next stage of development. Acuity President and CEO Dale Pfost told RNAi News in an e-mail this week that his company is aiming to begin phase II development of its AMD drug before the end of the year.
Meanwhile, Intradigm readjusted its timeline for a cancer therapy, pushing it back to the first quarter of 2006 from previous projections of year-end 2005. It also dropped plans to work on diseases associated with ocular angiogenesis on its own. Chairman and CEO John Spears told RNAi News in an e-mail this week that the company would, however, consider working with a collaborator in the ocular field.
Benitec also changed up a development timeline, with CEO Sara Cunningham telling RNAi News that a phase I trial for an HIV treatment would likely start in the first half of next year, as opposed to sometime this year as stated on the company's website. Benitec also recently announced that a hepatitis C drug is expected to reach phase I testing in the second half of 2006.
Finally, newcomer Galenea provided for the first time guidance on its RNAi-based influenza drug, targeting an IND for the second half of 2007.
• Doug Macron ([email protected])
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RNAi Therapeutic Pipeline Update
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Company
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Indication
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Timeline
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| Acuity | Age-related macular degeneration | Phase II in 2005 |
| Alnylam Pharmaceuticals | Age-related macular degeneration | Phase I in the second half of 2005 |
| Respiratory syncytial virus | Phase I in the first half of 2006 | |
| Atugen | Cancer | IND in 2006 |
| Benitec | Hepatitis C | Phase I in the second half of 2006 |
| HIV | Phase I in first half of 2006 | |
| Calando | No programs announced | No timeline |
| CombiMatrix | Conditions associated with unconventional warfare | No timeline |
| Hepatitis C | No timeline | |
| HIV | No timeline | |
| CytRx | Amyotrophic lateral sclerosis | No timeline |
| Obesity | No timeline | |
| Type II diabetes | No timeline | |
| Cytomegalovirus | No timeline | |
| Galenea | Influenza | IND in the second half of 2007 |
| GeneCare | Cancer | Phase I in 2007 |
| Intradigm | Cancer | Phase I in first quarter 2006 |
| Nastech | Rheumatoid arthritis | No timeline |
| Nucleonics | Hepatitis B | IND before end of 2005 |
| Hepatitis C | IND in third quarter 2006 | |
| Sirna Therapeutics | Age-related macular degeneration | Phase II in mid-2006 |
| Permanent hair removal | Phase I in second quarter of 2006; phase II in 2007; phase III in 2009 | |
| Hepatitis C | Phase I by the end of 2006 | |
| Quark Biotech | Age-related macular degeneration | IND by the end of 2005 |
| Diabetic retinopathy | IND by the end of 2005 | |