Diurnal Group surges on successful testosterone clinical study
revealed positive results from the company’s DITEST™ (its native oral testosterone formulation) phase I proof-of-concept clinical trial on Wednesday.
The study found that oral administration of DITEST™ to 24 males with low levels of testosterone due to primary or secondary hypogonadism, achieved testosterone levels of a healthy young male adult that were less variable than testosterone undecanoate.
The study also found no impact on the rate and extent of absorption of testosterone from DITEST™ 200mg whether taken with either food or in the fasted state, compared to testosterone undecanoate which requires a high-fat meal to achieve therapeutic testosterone levels.
Shares in Diurnal Group were 11.48% higher at 34p during Wednesday morning trading
Professor John Newell-Price, University of Sheffield and Lead Investigator on the study, said: "Currently available topical formulations of native testosterone have significant compliance and potential safety issues while, to date, attempts to create oral preparations of modified testosterone have resulted in products with considerable pharmacokinetic variability and a requirement to be taken with a high-fat meal.”
He added: “For hypogonadal men, there is an unmet need for an effective and convenient oral testosterone replacement therapy. I am strongly encouraged by these study results, which demonstrate that the DITEST™ formulation has the potential to address these needs."
Martin Whitaker, CEO of Diurnal, also commented on the study: "The positive outcome of this trial is another meaningful step towards achieving Diurnal's vision of becoming one of the world's leading endocrinology speciality pharma companies.”
He said: “We are excited by the potential of DITEST™ to address a significant unmet patient need for hypogonadal men, which affects over 60 million men globally2. DITEST™ is our next pipeline product in the clinic after our lead programmes, Alkindi® and Chronocort®.”
He added: “We look forward to engaging with regulators in the US and Europe to progress DITEST™ to late stage clinical trials, and to discussing these positive trial data with potential development and commercialisation partners."
Diurnal believes the product could be the first effective oral native testosterone treatment in what it estimates to be a $4.8 billion global market.
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