Regulus Therapeutics Phase 1b Trial Results
Regulus Therapeutics Inc announces promising topline results from the second cohort of patients in its Phase 1b multiple-ascending dose (MAD) study of RGLS8429 for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study assesses the treatment’s efficacy across different dose levels, focusing on urinary polycystins, kidney volume, cyst architecture, and overall kidney function.
Mechanistic Dose Response
RGLS8429 demonstrates clear evidence of a mechanistic dose response at the 2mg/kg dose level, exhibiting greater biological activity compared to lower doses and placebo, particularly evident in urinary polycystin levels after three months of dosing.
Encouraging Imaging Results by Regulus Therapeutics
Exploratory imaging-based biomarkers show promise, with patients displaying the highest increases in polycystin levels experiencing notable reductions in total kidney volume and cyst volume. This underscores the potential therapeutic impact of RGLS8429 on ADPKD progression.
Upcoming Trial Cohorts
The third cohort is currently undergoing dosing at 3mg/kg of RGLS8429, with data readout expected in mid-2024. Additionally, a fourth cohort has been added for an open-label fixed dose of 300mg, with screening set to commence in the second quarter of 2024.
Private Placement Announcement
Furthermore, Regulus Therapeutics has revealed an oversubscribed $100 million equity private placement, with investors agreeing to purchase shares at $1.60 per share. Notably, certain investors opt for newly designated, non-voting Class A-6 convertible preferred stock at a purchase price of $160.00 per share.
Market Response to Regulus Therapeutics Results and Placement
Following the announcements of its results and the private placement, Regulus Therapeutics experiences a significant surge in its stock price, opening Tuesday’s trading session at $2.33 after closing at $1.38. Moreover, trading volume skyrockets, with 122.9 million shares traded by noon compared to the daily average volume of 37.89 thousand shares.
At the time of this publication, Regulus Therapeutics Inc stock (RGLS) has witnessed a surge.
Regulus Therapeutics Inc
Current Price: $2.76
Change : +1.38
Change (%): (100.00%)
Volume: 122.9M
Source: Tomorrow Events Market Data
