Clene Inc. (CLNN) experienced a rise of 6.93% in the aftermarket. However, the last trading session closed at $5.05 with a decline of 4.36%.
Patient Enrollment in the HEALEY ALS Platform Trial
On 15th November 2021, CLNN announced the completion of enrollment in the HEALEY ALS Platform Trial. The HEALEY ALS Platform Trial is a multi-center clinical trial examining safety and effectiveness.
Moreover, it is the first platform trial in the field of ALS. And it was created with a common placebo arm to cut down on trial time, expenses. It is done in over 50 specialists ALS clinical trial locations around the United States, with significant financial assistance from generous donors and charities.
So what?
CLNN is thankful to people living with ALS for their support and involvement in this groundbreaking platform study, which has allowed the company to reach this vital milestone. This accomplishment is critical for trial completion and results reporting, clearing the path for revolutionary research to continue and life-saving medicines for patients with ALS to be discovered.
CLNN anticipates finishing the 24-week double-blind treatment phase and releasing top-line unblinded results in the second half of 2022. Furthermore, CLNN expects to file a New Drug Application with the FDA for disease modification in ALS in the second half of 2022. Lastly, CNM-Au8 may enhance outcomes for ALS patients with few therapy choices by accelerating cellular energy metabolism, according to the researchers.
Third-quarter 2021 Results of CLNN – What’s up?
CLNN released third-quarter 2021 results on 9th November 2021. The cash and restricted cash were $60.6 million more than $59.3 million as reported by the company. Moreover, research and development costs were over $6.1 million, more than $4.0 million. However, the company reported a net loss of about $10.5 million and $5.7 million, respectively.
Now what?
The company thinks that the top-line results from RESCUE-ALS show that CNM-Au8 has the potential to help patients with this severe and fatal disease. The findings add to the nanotherapeutics’ capacity to cure energetic failure, which is at the root of many neurological illnesses. Lastly, CLNN plans to disclose results from the Phase 2/3 HEALEY ALS Platform Trial in the second half of 2022, based on these findings.
Second Quarter 2021 Results of CLNN – Was it a strong quarter?
CLNN reported second-quarter 2021 results on 10th August 2021. The Phase 2 REPAIR clinical studies yielded promising top-line outcomes. The REPAIR clinical trial program’s goal was to show the impact of Clene’s energy-enhancing nanotherapeutic. Before and after 12 weeks of daily oral treatment with CNM-Au8, patients were scanned using 31phosphorous magnetic resonance spectroscopy, a non-invasive brain imaging method.
Moreover, the company presented interim data from the Phase 2 RESCUE-ALS study at the Annual Meeting. CNM-Au8 is tested in individuals with early ALS in the RESCUE-ALS research, which is a randomized, placebo-controlled Phase 2 trial. The Motor Unit Number Index is used as the study’s primary endpoint (MUNIX). Lastly, MUNIX is an electrophysiological approach that estimates the number of functional motor neurons.
