The UK’s Renovo Group has presented yet more “highly positive” data from a mid-stage trial of its anti-scarring drug Juvista which was recently licenced to Shire.
The Manchester-headquartered firm says that a Phase II study of Juvista (human recombinant transforming growth factor beta-3) which, for the first time, used a drug substance manufactured by Lonza Biologics that will be used for Phase III trials and commercial supply, met its primary endpoint and is highly statistically significant.
Specifically, the trial which involved healthy male and female volunteers aged 18 to 72 confirmed previous studies and revealed that scars resulting from wounds treated with Juvista show improved appearance compared to placebo-treated wounds on the same subject. The results are based upon an evaluation of scars over a period beginning at week six until seven months post-surgery, “indicating a permanent regeneration of more normal skin,” Renovo stated.
This is the fifth statistically significant Phase II trial reported for product, noted chief executive Mark Ferguson, and is particularly important given that it is “the first time that we have tested Juvista manufactured drug substance at Lonza and the lyophilised product intended for Phase III and commercial supply. He added that the data “supports our previous findings that the optimum dose of Juvista is 200ng/100ul/linear cm of wound margin, given once at the time of surgery” and also establishes a broad dosage window of 50-500ng.
The results from the trial will please partner Shire which, in return for exclusive rights to Juvista outside of the European Union, made an equity investment in Renovo in June of $50 million to get a 6.7% stake, and also made an upfront payment of $75 million. The whole deal could be worth $700 million plus royalties to Renovo, depending on filings and approvals.
The US market alone could be worth $4 billion, with 42 million patients undergoing surgery each year, and Shire has previously cited consumer research in the USA which shows that 85% of patients would self-pay for the reduction or prevention of scarring.”