Statistically Significant Efficacy of Juvista Demonstrated in Phase 2 Trial Using Drug Substance Manufactured by Lonza Biologics
Renovo licensed the worldwide development and commercialisation rights for Juvista, to global specialty biopharmaceutical company, Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) in June 2007, with the exception of the European Union where Renovo retained all rights.
Phase 2 Clinical Trial 0050 Highlights
- Trial meets its primary endpoint and is highly statistically
significant (p<0.0001)
- Demonstrates clinical efficacy of Lonza manufactured,
microbially derived, drug substance, proposed to be used in Phase 3
trials and commercial supply
- Supports 200ng/100?l/linear cm of wound margin as an
appropriate dose for Phase 3 studies and establishes a broad
response range (50-500ng)
- Fifth statistically significant Phase 2 efficacy trial reported for Juvista
This trial was a single-centre, randomised, double-blind, placebo controlled Phase 2 study designed to investigate the impact of varying doses of Juvista given once at the time of surgery. Healthy male and female volunteers (aged 18-72) were given Juvista doses of 5, 50, 200 and 500 ng per 100?l per linear cm of incision, as well as placebo. The trial used for the first time drug substance manufactured by Lonza in the lyophilised formulation intended for Phase 3 and commercial supply.
This study confirmed previous trials and showed that scars resulting from wounds treated with Juvista show improved appearance compared to placebo treated wounds on the same subject. These results are based upon an evaluation of scars over a time period beginning at week 6 until 7 months post surgery, indicating a permanent regeneration of more normal skin.
This is the fifth statistically significant Phase 2 efficacy trial reported for Juvista. It was the first time that 500ng given once had been assessed for efficacy.
The 50ng and 500ng doses were both statistically significant (p=0.0018 & p=0.0009 respectively), demonstrating a broad dose response window. In line with previous studies, 200ng produced the greatest magnitude of effect (p<0.0001), suggesting that this may be an appropriate dose to select for Phase 3 clinical trials. Following dosing with 200ng the response rate (71%), as assessed from photographs at 7 months by an independent external panel, was similar to that reported previously.
Professor Mark Ferguson, Chief Executive Officer, commented:
"This fifth statistically significant trial is very important for Renovo because it is the first time that we have tested Juvista manufactured drug substance at Lonza and the lyophilised product intended for Phase 3 and commercial supply.
"Pleasingly this trial supports our previous findings that the optimum dose of Juvista is 200ng/100?l/linear cm of wound margin, given once at the time of surgery, with a broad dosage window of 50-500ng/100?l/linear cm.
"We look forward to progressing the development of Juvista with our partner, Shire."
For further information:
Renovo
Professor Mark Ferguson, Chief Executive Officer
+44 (0) 161 606 7222
Simon Bielecki,
Head of Communications
+44 (0) 161 606 7328
Buchanan Communications
Tim Anderson/Lisa Baderoon/Mary-Jane Johnson
+44 (0) 20 7466 5000
Trial overview
This trial (Study RN1001-0050) was a randomised, double-blind, placebo controlled Phase 2 study designed to investigate the efficacy of varying doses of Juvista on scar improvement. 39 male and female subjects aged between 18 and 72 years old were enrolled allowing the study of 312 wounds and scars.
Four 1 cm surgical incisions were made all the way through the skin by a plastic surgeon at the same time in similar anatomical locations on both the right and left arms of each subject. Incisions were treated with Juvista or placebo so that each subject acted as their own control. Juvista was administered once by intradermal injection along the wound margins at four doses (5, 50, 200 and 500ng/100?L/linear cm wound margin). Placebo was administered to the site matched location on the other arm.
In the trial all scars were assessed clinically and photographed under standard conditions at week 6 and months 3, 4, 5, 6 and 7. The appearance of the scars was then measured using a visual analogue scale (VAS) by an independent panel of either plastic surgeons or lay people (to simulate customers).
This study confirmed previous trials and showed that scars resulting from wounds treated with Juvista show an improved appearance compared to placebo. Doses in the range of 50-500 ng/100?l/linear cm yielded statistically significant results on the primary endpoint. The results also suggest a dose of 200 ng/100?l/linear cm may be an appropriate dose for Phase 3 clinical trials.
In this study, tolerability of Juvista was generally good. 14 days after surgery mild to moderate erythema was reported for sites treated with both placebo and Juvista. No subjects reported severe erythema or any erythema-related AEs.
About Renovo Group plc
Renovo is a biopharmaceutical product company and is the world leader in scar prevention and reduction research and the development of drugs to prevent and reduce scarring. The Company has a highly skilled management team with over 30 years of research experience in the field of scarring and significant pharmaceutical industry expertise.
Scarring can result from acute injury in, or surgery to, the skin, blood vessels, eyes, nerves, internal organs, tendons and ligaments. These are high value markets of significant unmet medical need.
Renovo has a portfolio of drugs which exploit different novel mechanisms of action to prevent and reduce scarring at multiple body sites and to accelerate healing. Juvista, Renovo’s lead drug for the prevention and reduction of scarring in the skin has been safely administered to over 1,500 human subjects and has reported statistical and clinical significance in five Phase 2 efficacy trials.
Renovo announced in June 2007 that it had signed an exclusive licensing agreement with Shire plc to develop and commercialise Juvista. The agreement covers every country in the world except the European Union, the rights to which have been retained by Renovo.
Under the terms of the deal Renovo has already received an initial payment of US$125 million, consisting of a US$75 million upfront payment and US$50 million equity investment in Renovo Group Plc. Contingent on the successful development and commercialisation of Juvista Renovo will be eligible for further payments of up to $700 million together with escalating royalties on sales
Zesteem®, Renovo’s lead drug for the acceleration of wound healing in the skin, commenced Phase 3 clinical trials in December 2006. Prevascar™ reported statistically significant Phase 2 efficacy data for the prevention and reduction of scarring in the skin in April 2007 and is additionally being investigated for enhancing regeneration of peripheral nerves following injury or trauma.
According to external research, the potential commercial market for prevention and reduction of scarring in the skin is worth, in the order of, $4 billion per annum in the US alone.
For further information on Renovo please visit: www.renovo.com
About Shire plc
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder, human genetic therapies, gastrointestinal and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit Shire’s website: www.shire.com.
About Lonza
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SWX Swiss Exchange. In 2006, Lonza had sales of CHF 2.91 billion. Further information can be found at www.lonza.com
Posted: September 2007
