Products in Development
Currently, ATL is overseeing research on three drugs licensed in from Isis. ATL1102 (injection), a second-generation antisense drug to VLA-4, has shown “outstanding activity in Phase II studies potently reducing new active brain lesions in multiple sclerosis patients,” explained Diamond. It also has the potential to assist in the release of hematopoietic stem cells for their collection from the blood for use in the treatment of cancer, he added.
“We are, however, particularly keen on our drug ATL1103, which is an antisense inhibitor of the growth hormone receptor (GHr). This drug is in a Phase II clinical trial currently under way in Europe for the treatment of acromegaly,” continued Diamond. “Interim data from the trial is anticipated at the end of this year.”
Diamond pointed out that GHr is expressed in the liver, which is an ideal target tissue for antisense drugs as they accumulate in the liver at high concentrations. Several antisense drugs in the Isis pipeline are directed to targets expressed in the liver, and have demonstrated potent pharmacodynamic and pharmacological effects, he added.
The company also views acromegaly as a smart first-up lead indication, before expanding into cancer treatment.
“Acromegaly is an orphan drug disease, and orphan drug development is supported by development, regulatory, and IP incentives, which makes it attractive and affordable from a development perspective,” Diamond pointed out.
The company is also very satisfied with the endpoint for treating acromegaly, which is normalization of serum IGF-I (sIGF-I).
“Acromegalics have a tumor of the pituitary gland which causes them to produce too much growth hormone and, in turn, excessive amounts of IGF-I in the blood that leads to all the side-effects and significant morbidity and mortality associated with the disease,” said Diamond.
“sIGF-I is an easy endpoint to measure. It is also able to be assessed through preclinical and clinical development. sIGF-I normalization is also the endpoint for regulatory approval of acromegaly therapies. So we have the same, easy-to-measure endpoint, through all stages of development.”
He added that the company has shown that ATL1103 reduces sIGF-I in all its preclinical animal studies in mice and monkeys to date, and there’s been a preliminary indication of activity with reductions of sIGF-I in its Phase I normal volunteer study.
Other products in the ATL pipeline include ATL1102 (inhaled), which is in preclinicals as a potential treatment for asthma, and ATL1101, also in the preclinical stage, where it is being investigated as a potential therapy for cancer.
Looking ahead to the next 5 to 10 years, Diamond expects ATL to successfully commercialize the drugs in its current pipeline through successful licensing and/or joint development arrangements.
“As highlighted earlier, we also have the goal of taking one of these drugs all the way to market ourselves,” he said. “This would likely be for an orphan drug indication, and our current best prospect for this is ATL1102 for stem cell mobilization.”