Rare and orphan diseases specialist Amryt Pharmaceuticals PLC (LON:AMYT) has revealed positive results of a newly completed pre-clinical study on a key product designed to treat acromegaly, an excess of growth hormone.
The AIM-listed firm said the trial compared its drug compound AP102 - a somatostatin analogue therapy - with pasireotide, an approved product for treating patients with resistant acromegaly.
The group said AP102 did not demonstrate the potential to cause diabetes, an observation which, if replicated in clinical studies, could be clinically beneficial in treating acromegaly.
Mark Sumeray, Amryt’s chief medical officer, said: “These positive data results are encouraging and further reinforce our view that AP102 has the potential to improve outcomes for patients suffering from acromegaly, a rare and very distressing disorder which leads to excess growth of the body's tissues over time.
“As we previously reported in early November, the U.S. Food and Drug Administration granted orphan drug designation to AP102 and we are progressing AP102 towards clinical trials in 2017."
Amryt's study used a well-established diabetic rat model to examine whether or not AP102 has an effect on glucose levels or on food/water intake compared with controls.
The study results showed that AP102 had no effect on either in diabetic rats compared with controls. It said this indicates no impairment in glucose control in these diabetic animals when treated with AP102.
Brokers bullish ...
In a note to clients, analysts at Shore Capital pointed out that that Amryt’s AP102 is “the only product in development that targets SSTR 2 and 5 without causing an increase in glucose (and, therefore, an increased risk of diabetes), as far as we are aware”.
Stifel analyst Max Herrman pointed out that the pre-clinical trial results demonstrate ”a clear potential safety advantage of AP102, its next generation somastatin analogue, compared with Novartis’s Signifor”.
In a note to clients, he added: “The market for somastatin analogues was worth c.$2.3bn in 2016. We forecast sales of AP102 of $378m by 2029E although we do not include it in our 49p valuation of Amryt since it has yet to enter clinical development.”
The analyst reiterated a ‘buy’ rating on Amryt shares, saying: “With Episalvan due to start Phase III trials in epidermolysis bullosa in 1H17 and AP102 entering the clinic later in 2017, we believe there are multiple catalysts for the shares in 2017.”
Around midday, Amryt shares were over 4% higher, up 0.75p at 17.75p.
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