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Drawbridge Pharmaceuticals Announces Successful Clinical Trial Results For Phaxan™ And Grant Of U.S. Patent



4/16/2014 8:29:23 AM

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MELBOURNE, AUSTRALIA: April 16, 2014—Drawbridge Pharmaceuticals Pty Ltd (Drawbridge) is pleased to announce that it has completed a Phase 1C clinical trial of Phaxan™ - alphaxalone dissolved in sulfobutyl ether beta cyclodextrin (SBEßCD). The randomised, double blind dose finding study using a Bayesian design was conducted to compare the anaesthetic properties of Phaxan™ with propofol, which is the current gold standard for intravenous anaesthesia.

The clinical trial was conducted at the Jessie McPherson Private Hospital in 24 healthy male volunteers under the guidance of Investigator, Dr John Monagle, Director of Monash Anaesthesia and Pain Management, at Monash Health.

The parameters assessed for ninety (90) minutes after drug injection delivered as a single bolus dose were: blood pressure, bispectral index (BIS), oxygen saturation, need for airway and ventilatory support, pain on injection, involuntary movement, nausea and measures of recovery — the Richmond Agitation and Sedation Scale (RASS) and the Digital Symbol Substitution Test (DSST). In addition arterial blood samples were taken for routine analysis and measurement of complement fractions, C3 and C4.

Phaxan™ is a water-based preparation making it easy to administer and eliminating the contamination issues of lipid-based propofol. All of the endpoints set-out in the protocol have been successfully achieved as listed below:

Primary endpoints:

- Phaxan™ proved to be an effective fast-onset short acting intravenous anaesthetic equal to propofol - A greater safety profile was demonstrated by Phaxan™ compared with propofol
- Phaxan™ caused less depression of blood pressure and respiratory control compared with propofol; these differences were highly significant

Secondary endpoints:
- Phaxan™ caused no pain on injection while propofol caused pain and discomfort on injection in more than 50% of subjects
- Phaxan™ caused no nausea
- Involuntary muscle movements occurred only in the propofol treated group
- Cognitive function was preserved after Phaxan™ anaesthesia; an effect significantly better than with propofol
- Phaxan™ caused no change in complement C3 and C4 levels

According to Professor Colin Goodchild, Chief Medical Officer at Drawbridge Pharmaceuticals, “This is the first study in humans that compares the anaesthetic properties of Phaxan™ and propofol. We are very excited to see that the results clearly confirm all of the preclinical results with Phaxan™. This clinical trial confirms that Phaxan™ is as fast as propofol in onset and offset of intravenous anaesthesia with improved cardiovascular and respiratory safety.”

“We are also pleased to report that the results clearly show that Phaxan™ administration was followed by a fast, clear headed recovery characterised by significantly better cognitive function than after propofol,” said Professor Goodchild.

Drawbridge has a robust patent portfolio around its lead drug candidate, Phaxan™, in the United Kingdom, Australia, New Zealand, Hong Kong, Singapore and South Africa with coverage to 2031. Patent number 8697678 has also recently progressed to grant in the United States.

“This study clearly shows that Phaxan™ has the clinical capacity to replace propofol as the drug of choice for intravenous anaesthesia, preclinical sedation and sedation in the ICU,” said Dr Anthony Filippis, CEO at Drawbridge Pharmaceuticals.

“Drawbridge is now engaged in active discussions with potential partners regarding the further development of Phaxan™. We are confident that Phaxan™ will be successfully commercialised in the near future,” said Dr Filippis.

The detailed clinical results of this trial are available under confidentiality.

About Drawbridge Pharmaceuticals
Drawbridge Pharmaceuticals was founded in 2011 and is a privately-held biotechnology company, headquartered in Melbourne, Australia. The company is developing innovative neuroactive steroid compounds for use in critical care situations. Phaxan™ is the lead compound for use as a fast onset and offset intravenous general anaesthetic and sedative.

www.drawbridgepharmaceuticals.com.au

About Phaxan™
Phaxan™ is a novel water based formulation of the neuroactive steroid, alphaxalone. It has a wide therapeutic index and rapid onset and offset of action. The anaesthetic agent in Phaxan™ has been administered in the past as Althesin? when formulated in a different excipient. It was withdrawn in 1984 because of problems with the formulation. Phaxan™ does not have the problems of the Althesin? formulation and is superior to propofol in preclinical models.

Phaxan™ is a registered trade mark for alphaxalone formulated in sulfobutyl ether beta cyclodextrin being developed by Drawbridge Pharmaceuticals.

Dr Anthony Filippis and Prof. Colin Goodchild are available for interviews

Media enquiries:
Christine Filippis, Mendleson Communication: ph (03) 9421 6520, email christine@mendleson.com.au

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