The modifications, which follow recent feedback from the US Food and Drug Administration, and a streamlining of the company's planned clinical trial sites network are expected to generate "meaningful cost savings," Rhythm said.
The company now expects that its existing cash, cash equivalents and short-term investments will be adequate to finance operations into at least Q4 of next year, compared with a previous projected cash runway into at least H2 2023.
The modifications include the elimination of a fifth sub-study in the phase 3 Emanate trial, in which the first patient has been enrolled, leaving it with four independent sub-studies, the company said.
Rhythm also modified enrollment criteria in the separate phase 2 Daybreak trial to initially focus on certain rare variants which it believes "have the highest probability of success."
The company said it paused certain patient enrollment in Daybreak but will consider resuming it "based on the early clinical data from the prioritized genes."
|-- Earnings Flash (AQS) AEQUUS PHARMACEUTICALS Repor...|
|Insider Buy: Bitnile Holdings|
|Insider Buy: Macerich|
|Insider Sell: Velodyne Lidar|
|Insider Sell: Xometry|