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Extinction Pharmaceuticals, Inc. is a drug development company with a proprietary and revolutionary therapeutic approach (i.e., administering D-cycloserine in conjunction with therapy) for treating anxiety disorders and other afflictions that can benefit from traditional talk therapy treatments. Fundamentally, our drug works by consolidating the learning from a therapy session, thereby making therapy sessions more efficient. This effect has been demonstrated in placebo-controlled, double-blind human clinical trials for panic disorder, social anxiety disorder, obsessive-compulsive disorder, and simple phobia, and is currently being tested in investigator-initiated clinical trials for addiction, autism, stroke recovery, and other conditions.
Relative to other drugs, we believe that the costs of getting our drug to market will be inexpensive, and believe the likelihood of approval is high, particularly given: (i) the unique mechanism of action of our drug, (ii) its limited, non-chronic dosing, (iii) its safety, and (iv) the deficiencies of the current gold standard pharmaceutical treatments (SSRIs) for anxiety disorders. We anticipate peak annual sales in the $300M to $500M range.
1. Our drug is safe.
2. Our drug is effective.
3. Our drug targets under-served clinical needs with large market opportunities.
4. Our approach is unique, unlike anything else in the field.
5. We anticipate shortened regulatory approval via FDA's 505(b)2 pathway.
6. We have a strong IP Position.
We intend to develop D-cycloserine as a branded pharmaceutical for treatment of anxiety disorders and other related afflictions, and recently conducted a pre-IND meeting with FDA. Our development efforts are focused exclusively on D-cycloserine (DCS), a drug that has been approved for many years for the treatment of tuberculosis. In the U.S., DCS is not widely used and is not available as a generic. Importantly, the effect of DCS on learning consolidation occurs at low doses of DCS which are not currently approved by FDA. DCS is very safe at the low doses we utilize, which correspond to about 5% of the typical daily DCS dose for tuberculosis treatment. We can rapidly enter human clinical trials after filing an IND, and anticipate a relatively short development cycle utilizing FDA’s 505(b)2 process.
All-in estimate through NDA approval is $35M or less.
The company was founded by Emory University professors Michael Davis, Ph.D., and Kerry J. Ressler, M.D./Ph.D., along with Extinction Pharmaceuticals CEO Jason P. McDevitt, Ph.D.
- Hurley Consulting Associates, Ltd.
- CIT GAP Fund
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