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This randomized, double-blind, placebo-controlled, single ascending dosestudy in healthy volunteers is being closely followed by a multiple ascendingdose study in healthy subjects. Both studies are designed to evaluate thesafety, tolerability and pharmacokinetics of KNS-760704 in human subjects.
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"The initiation of Phase 1 represents a significant milestone in Knopp'sefforts to develop a safe and effective therapy for a serious unmet medicalneed," said Michael Bozik, M.D., president and chief executive officer ofKnopp. "We look forward to completing these safety studies and moving rapidlyto advance the compound into initial clinical trials in ALS patients."
About KNS-760704
KNS-760704 is an orally administered small molecule in clinicaldevelopment by Knopp for the treatment of amyotrophic lateral sclerosis (ALS).The drug is an optical enantiomer of a selective, high affinity dopamineagonist marketed in other neurological indications. Both KNS-760704 and themarketed agonist demonstrate neuroprotective properties independent ofdopamine receptor activity, but KNS-760704 exhibits greatly reduced dopaminereceptor affinity. This makes it possible to clinically evaluate the potentialneuroprotective activity of KNS-760704 over a broad dose range.
About ALS
Amyotrophic lateral sclerosis (ALS), often called Lou Gehrig's disease, isa rapid, universally fatal neurodegenerative disorder characterized byprogressive muscle weakness and wasting. ALS affects adults in the prime oflife and creates a substantial burden for caregivers. U.S. prevalence isnearly 30,000 and the incidence is 1.2 per 100,000. Only a single drug hasbeen approved for the treatment of ALS. Life expectancy after symptom onset isusually three to five years.
About Knopp Neurosciences Inc. (www.knoppneurosciences.com)
Knopp Neurosciences is a drug discovery and development company focused ondelivering breakthrough treatments for neurological disorders throughinnovation, experience, and partnership. The company's lead product candidateis KNS-760704, an orally bioavailable small molecule in development for thetreatment of ALS. Knopp's leadership includes experienced neuroscience drugdevelopment and discovery executives formerly associated with majorpharmaceutical companies. Knopp's financing has been led Saturn Capital Inc.of Boston as placement agent and Saturn Partners II as lead funder.
This press release contains "forward-looking statements," includingstatements relating to Knopp's planned regulatory filings and clinicaldevelopment programs for KNS-760704. All forward-looking statements are basedon management's current assumptions and expectations and involve risks,uncertainties and other important factors, specifically including theuncertainties inherent in clinical trials and product development programs,the availability of funding to support continued research and studies, theavailability or potential availability of alternative therapies or treatments,the availability of patent protection for the discoveries and strategicalliances, as well as additional factors that may cause Knopp's actual resultsto differ from our expectations. There can be no assurance that KNS-760704will be successfully developed or manufactured or that final results ofclinical studies will be supportive of regulatory approvals required to marketthe products. Knopp undertakes no obligation to update or revise any suchforward-looking statements, whether as a result of new information, futureevents or otherwise.
SOURCE Knopp Neurosciences Inc.
