DNL.L Regulatory News (DNL)

11 October 2021

Diurnal Group plc

("Diurnal" or the "Company")

Phase 1 data for DITEST™ published in European Journal of Endocrinology

US IND submission for the Company's third novel product expected in Q4 2021

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the results from the Company's Phase 1 clinical trial for its development product DITEST™ (native oral testosterone formulation) as a treatment for male primary and secondary hypogonadism have been published in the peer-reviewed European Journal of Endocrinology.

DITEST™ is the Company's third product and is a native oral testosterone therapy in development for the treatment of male hypogonadism. The Company's Phase 1 study (DITEST-001) evaluated the pharmacokinetics, safety and tolerability of a single dose of native oral testosterone in 24 adult men with primary or secondary hypogonadism demonstrating the achievement of testosterone levels within the healthy young male adult normal range after oral administration.

Secondary endpoints of the study demonstrated that there was no impact on the rate and extent of absorption of testosterone from DITEST™ whether taken with either food or in the fasted state, representing a major difference from testosterone undecanoate. There were no serious adverse events in the DITEST™ arm of the study, and levels of the potent testosterone derived androgen, dihydrotestosterone (DHT), were lower than seen with testosterone undecanoate. The article in the European Journal of Endocrinology concludes that dosing independent of food and a lower risk of supraphysiological DHT levels may be advantages for patients with hypogonadism.

The European Journal of Endocrinology article, entitled "An oral lipidic native testosterone formulation that is absorbed independent of food" can be accessed here: https://eje.bioscientifica.com/view/journals/eje/185/5/EJE-21-0606.xml.

Professor Richard Ross, a founding Director and Chief Scientific Officer of Diurnal, commented: 

"We are pleased to have the results from our Phase 1 clinical trial of DITEST™ published in a leading peer-reviewed endocrinology journal as we continue to progress the development of our third product. This paper reinforces our beliefs that DITEST™ could be an effective and differentiated therapy to address the significant unmet patient needs of the 60 million men, globally, who are affected by hypogonadism. The Company looks forward to submitting an Investigational New Drug Application to the US Food and Drug Administration shortly."

This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions.

Notes to Editors

About Hypogonadism

Hypogonadism results from failure of the testes (primary gonadal failure) or from failure of stimulation by the pituitary (secondary hypogonadism) resulting in testosterone insufficiency. In primary hypogonadism, failure of the testes can be congenital (inherited) or acquired during life due to a variety of causes (failure of the testes to descend into the scrotum, inflammation due to infections such as mumps, chemotherapy or radiotherapy affecting the testes, and following removal of the testes for testicular tumours). Secondary hypogonadism usually results from a benign tumour of the pituitary gland that causes hypopituitarism and may occasionally be congenital.

The hypogonadism market is a large and fragmented market. Diurnal estimates that in Europe and the US the market opportunity is around $5 billion per annum. Topical (gel) formulations are the current market leaders due to low bioavailability of testosterone in the body when administered by the oral route. However, these topical formulations have compliance and administration issues. Other testosterone replacement therapies for hypogonadism include intramuscular injections, testosterone patches and the only currently available oral forms are modified testosterones (such as testosterone undecanoate) that have limited label scope, well-documented pharmacokinetic variability, a requirement to be taken with a high fat meal and safety concerns.

Therefore, Diurnal believes that there is a patient need for an oral (native) testosterone preparation.

About DITEST™

DITEST™ is a novel formulation developed by Diurnal comprising native testosterone adapted for oral delivery for the treatment of hypogonadism. The main challenge with oral delivery of native testosterone is that, whilst the hormone undergoes rapid and complete absorption, there is considerable metabolism in both the gut wall and during first hepatic pass which accounts for up to 98% reduction in testosterone bioavailability (the amount of drug in the body that is able to have an active effect). Diurnal's approach is a proprietary lipid-based formulation that aims to provide improved bioavailability of testosterone. An additional potential feature of the native testosterone formulation demonstrated in both preclinical studies and now in this clinical study is that it shows similar absorption and bioavailability in both the fed and fasted state and therefore potentially can be taken without a substantial meal, which is a requirement with many alternative oral modified-testosterone formulations.

Patents protecting DITEST™ have already been granted in the US, Europe and other major territories worldwide.

About Diurnal Group plc

Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

For further information about Diurnal, please visit www.diurnal.co.uk 

Date of Preparation: October 2021 Code: CORP-GB-0158