Thinly traded nano cap Aeterna Zentaris (AEZS +23.1%) reaches the clinical endpoint in its Phase 3 study, ZoptEC, assessing Zoptrex (zoptarelin doxorubicin) in women with treatment-resistant advanced endometrial cancer. Data lock and the release of top-line results should happen in April. Enrollment was completed in June 2015 and the final dosing was completed in January 2016.
The primary endpoint is overall survival compared to doxorubicin alone.
Zoptrex combines a synthetic peptide carrier with the chemo agent doxorubicin. The carrier, a modified natural hormone with a strong affinity for the LHRH (luteinizing hormone-releasing hormone) receptor, enables the selective delivery of the chemo agent to LHRH receptor-positive tumors.
Aeterna Zentaris (NASDAQ:AEZS) -38.3% AH after reporting that the confirmatory Phase 3 clinical trial of Macrilen failed to achieve its objective of validating a single oral dose of macimorelin for the evaluation of growth hormone deficiency in adults.
AEZS says it is evaluating the outcome of the trial and will determine in the near future whether it will continue with the development of Macrilen.
Allergan (AGN +0.3%) exercises its option to acquire Rhythm Holding Company, LLC subsidiary Motus Therapeutics for $200M plus a contingent payment related to the first commercial sale of relamorelin, a ghrelin agonist about to enter Phase 3 development for the treatment of diabetic gastroparesis (DG). Earlier, Allergan paid $47M for the option to buy the relamorelin developer.
Top-line results from a Phase 2b trial prompted Allergan's move. Type 1 and type 2 diabetics treated with relamorelin for 12 weeks showed improvements in DG symptoms of nausea, post-prandial (after eating) fullness, abdominal pain and bloating in addition to a positive effect on gastric motility. Patients experienced a 75% reduction in vomiting frequency across all doses versus baseline, the primary endpoint, but it fell short of statistical significance due to an unexpected high rate of vomiting in the placebo group. Nevertheless, Allergan intends to advance relamorelin to Phase 3 development.
Diabetic gastroparesis is a disorder in which the movement of food from the stomach is slowed or stopped. The most frequent cause is damage to the vagus nerve, which controls the movement of food (motility) through the digestive tract.
Relamorelin (formerly RM-131) stimulates a hormone called ghrelin which increases appetite. Aeterna Zentaris (AEZS -7.9%) is developing a ghrelin agonist called Macrilen (macromorelin) for the treatment of adult growth hormone deficiency. Aratana Therapeutics (PETX -1.7%) is developing another, capromorelin, as an appetite stimulator in dogs.
Thinly traded nano cap Aeterna Zentaris (AEZS -8.6%) slumps on modestly higher volume in response to its announcement of a direct equity offering of 2.1M units at $3.60 to a single institutional investor.
Each unit consists of one share of common stock and 0.45 of a three-year warrant to purchase one share of common at $4.70.
Closing date is November 1. Net proceeds of ~$6.6M will fund the preparations and submissions of NDAs for Macrilen and Zoptrex, working capital and general corporate purposes.