Allena Pharmaceuticals Inc (NASDAQ:ALNA) expanded the clinical trial sites of URIROX-2. The company expects to post an interim analysis from this clinical trial in Q1 2022. Topline data for submitting Biologics License Application (BLA) will be available in Q2 2022.
ALLN-346 to treat patients with gout
Allena raised $22.7 million through a direct offering of shares in July 2020. The company initiated the Phase 1 clinical trial of ALLN-346, an oral enzyme therapeutic. The trial will investigate the effectiveness of the drug in curing renally impaired patients suffering from hyperuricemia and gout. The company will publish the initial readout of this trial by the end of 2020.
CEO of Allena, Louis Brenner, said the company is pleased to announce the first clinical study of ALLN-346 in humans. It is the first treatment for patients with gout and hyperuricemia. The existing treatment options available in the market are inadequate.
Reloxaliase to cure patients with EH
Allena is conducting the clinical trial of Reloxaliase, an orally administered enzyme, and a first in class treatment for enteric hyperoxaluria (EH). It recruited patients for this clinical trial even during the ongoing coronavirus crises.
The company will investigate the drug for safety and effectiveness in the second Phase 3 study under the URROX program, and the final result will be out in Q1 2022. Its positive results will allow Allena to submit for final approval of reloxalaise to cure patients with EH.
Allena is in discussions with the US FDA continually to expedite the registration paths of reloxalaise in patients with advanced CKD (Chronological Kidney Disease) and EH.
Allena maintains cash and CE (cash equivalents) of $26.5 million by the end of Q2 2020. It does not include $7.7 million raised by the company through bought-deal offering in July 2020. The company paid $3.5 million for interest and principal payments related to operating activities. Allena’s cash position is sufficient to fund capital expenditure and operating requirements beyond Q2 2021.
Allena’s spending on R&D is declined to $3.8 million in Q2 2020. It is on the backdrop of lower costs associated with reloxalaise program. The company narrowed down the net loss to $7 million in Q2 2020 from $11.3 million in Q2 2019.