UK specialty pharma company Diurnal is looking to raise around £5.4m ($6.8m) from a share placement to help fund the roll out of its lead products.
The cash will go towards the filing of a marketing application in Europe for Chronocort, Diurnal’s cortisol replacement product for patients with congenital adrenal hyperplasia (CAH), as well as a US filing for Alkindi as a replacement therapy for adrenal insufficiency. Both should be submitted before the end of the year.
The funds will also be used to boost Diurnal’s European sales capacity as it continues to roll out Alkindi in Europe after its approval by the EMA last year, and to pursue licensing deals for Chronocort and Alkindi in the US and other world markets.
Diurnal is recovering from a tricky period after Chronocort failed to meet its primary objective in a pivotal CAH study, sending its share price into freefall last October. CAH is a potentially life-threatening orphan condition caused by a block in cortisol production, an essential adrenal steroid hormone.
The sustained-release formulation of hydrocortisone (the synthetic version of cortisol) is designed to mimic the circadian rhythm of cortisol when given in a twice-a-day ‘toothbrush’ regimen – once in the morning and once at night – helping to control excess androgen and chronic fatigue in patients with CAH.
Chronocort failed to improve on conventional therapy in the phase 3 trial when it came to androgen control, but did better on secondary measures including the need for rescue therapy, and achieved control at a lower dose without the early morning peak in androgen levels seen with current drugs.
Last month, the EMA said the data was strong enough for a regulatory filing despite missing the primary endpoint of the study, recognising that its secondary benefits could be important clinical gains for the 47,000 or so patients with CAH in Europe. Diurnal estimates that the EU market for CAH therapies is worth around $300m.
The company started phase 3 testing of the drug in the US with the aim of filing for approval there in 2021, but decided to put the programme on hold after the EU trial missed the mark.
Alkindi meanwhile made its debut in Germany last year, Diurnal’s first-ever product launch, but suffered a setback after the country’s Institute for Quality and Efficiency in Health Care (IQWiG) concluded it had not been proven to be superior to generic hydrocortisone.
It has since been introduced in the UK and other European markets, and won the backing of the Scottish Medicines Consortium (SMC) last October.
In March, Diurnal also signed its first partnership for Alkindi with Swedish group Anthrop Pharmaceuticals, which covers the commercialisation of the drug in Sweden, Norway, Denmark, Finland and Iceland, a $3m-plus potential market.