Alder Biopharmaceuticals Inc (NASDAQ:ALDR) has presented preclinical data on ALD1613, an anti-adrenocorticotropic hormone for the treatment of adrenal hyperplasia and Cushing’s disease. The presentation, entitled ‘A Novel Anti-ACTH Antibody Neutralizes ACTH Activity and Reduces Glucocorticoids in Rats and Nonhuman Primates’ was made at Endo 2016, the Endocrine Society’s 98th Annual Meeting in Boston, Massachusetts.
In the presentation, ALD1613 was noted to inhibit ACTH-induces cortisol secretion in a mouse adrenal cell line. It was also observed that ALD1613 administration in rats with artificially high ACTH and corticosterone level resulted in a high and durable reduction of plasma corticosterone levels. ALD1613 in non-human primates demonstrated a stable and durable reduction in plasma cortisol levels by over 50%.
Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder noted that existing therapeutic options for patients with Cushing’s disease and hyperplasia comprise treatment that provides limited disease control and has significant side effects. He pointed out that he believes those limitations indicate a clear need for new therapies like ALD1613 that target ACT to diminish overproduction of cortisol. He indicated that they intended to use those findings as part of an IND filing that they plan to submit to the FDA during the second half of 2016.
Alder also recently reported that a phase 2b trial for another candidate ALD403 had met both primary and secondary endpoints, demonstrating migraine prevention in patients suffering from chronic migraines. The company noted that they had received positive top-line data from Phase 2b study patients with chronic migraines showing that ALD403 prevented migraines during the whole 12 week study period, achieving both primary and secondary efficacy endpoints.