Today’s Daily Dose brings you news about the anticipated clinical trial catalysts of Anavex Life, Histogen, and Lyra Therapeutics; disappointing migraine trial results of Satsuma, and the upcoming regulatory catalyst of Sol-Gel.
1. Anavex Life to Report Rett syndrome Trial Data in Q4
Anavex Life Sciences Corp. (AVXL) has completed its U.S. phase II study of ANAVEX2-73 in Rett syndrome and expects to announce topline results from this study in the next quarter.
Rett syndrome is a rare genetic neurological disorder characterized by severe impairments in speech, walking, eating, and even breathing. This disorder occurs almost exclusively in girls and its hallmark symptom is repetitive hand movements.
The interim data previously reported from the U.S. phase II Rett syndrome study of ANAVEX2-73 (blarcamesine) had demonstrated significant improvements in the two global efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score and the Clinical Global Impression – Improvement (CGI-I).
AVXL closed Thursday’s trading at $3.88, down 4.90%.
2. Can Histogen’s Androgenic Alopecia Trial Results Turn Heads?
Histogen Inc. (HSTO) has completed patient dosing in its phase Ib/IIa clinical trial of HST-001 for the treatment of androgenic alopecia in men.
Androgenic alopecia, also called male pattern baldness, is a type of hair loss caused due to hormone level changes in men.
The trial has enrolled 36 subjects with male pattern hair loss and top-line results are expected to be available in the fourth quarter of 2020.
HSTO closed Thursday’s trading at $1.71, down 1.72%.
3. Lyra Therapeutics Awaits LANTERN Study Results
Lyra Therapeutics Inc. (LYRA), on Thursday, provided data from its phase I trial of LYR-210 in the treatment of chronic rhinosinusitis, which demonstrated a significant reduction of sinonasal Type 2 inflammation in surgically naïve patients with chronic rhinosinusitis. The findings were presented at the 66th Annual Meeting of the American Rhinologic Society.
According to the company, the reduction of Type 2 inflammation suggests a correlation with rhinologic symptom improvement in chronic rhinosinusitis and could be a potential measure of LYR-210’s local anti-inflammatory effects at the site of inflammation in the sinonasal passages.
Commenting on the results, Robert Kern, Chair of the Department of Otolaryngology/Head and Neck Surgery at Northwestern University Feinberg School of Medicine and a co-author on the LYR-210 presentation, said, “Inflammation is the key driver for symptoms of chronic rhinosinusitis, and Type 2 inflammation, in particular, has been the most resistant to treatment. These new results demonstrate that LYR-210 not only reduces local markers of Type 2 inflammation but also reduces the associated CRS symptoms.”
LYR-210 as a potential preferred alternative to surgery is currently being tested in a phase II clinical trial, dubbed LANTERN, for chronic rhinosinusitis patients who have failed medical management. The top-line results from the LANTERN study are expected at the end of this year.
LYRA closed Thursday’s trading at $11.82, down 5.21%.
4. Satsuma Reels with Pain as Migraine Study Fails
Shares of Satsuma Pharmaceuticals Inc. (STSA) cratered Thursday, following disappointing results from its phase III efficacy trial of STS101 powder in the acute treatment for migraine.
STS101 is a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be self-administered with a proprietary pre-filled, single-use, nasal delivery device.
In the trial, dubbed EMERGE, STS101 of dosages 3.9 mg and 5.2 mg did not show statistically significant differences in the co-primary endpoints of freedom from pain and most bothersome symptoms at two hours post-administration when compared to placebo.
STSA closed Thursday’s trading at $5.62, down 75.92%.
5. Sol-Gel to Face FDA in April
Sol-Gel Technologies Ltd.’s (SLGL) New Drug Application for Epsolay topical cream for the treatment of inflammatory lesions of rosacea has been accepted for review by the FDA – with a decision expected on April 26, 2021.
Papulopustular rosacea, a chronic, and recurrent inflammatory skin disorder, typically begins after age 30 as flushing and subtle redness on the cheeks, nose, chin or forehead. Nearly 5 million Americans are estimated to have this disorder.
Epsolay contains encapsulated benzoyl peroxide, 5%, and if approved, it will be the first FDA-approved single-agent benzoyl peroxide prescription drug product.
Epsolay, if approved, will have to directly compete with Menlo Therapeutics’ (MNLO) ZILXI, which received FDA approval as recently as May of this year.
SLGL closed Thursday’s trading at $7.59, down 2.44%.
6. Stocks That Moved On No News
Agenus Inc. (AGEN) closed Thursday’s trading at $5.19, up 23.87%.
Paratek Pharmaceuticals Inc. (PRTK) closed Thursday’s trading at $5.63, up 21.08%.
Pulse Biosciences Inc. (PLSE) closed Thursday’s trading at $10.94, up 15.64%.
Precipio Inc. (PRPO) closed Thursday’s trading at $2.19, down 23.43%.
Sutro Biopharma Inc. (STRO) closed Thursday’s trading at $11, down 16.35%.
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