#United States #New York #BRAVYL #ALS Treatment #Woolsey Pharmaceuticals

Woolsey Pharmaceuticals Completes Series B Round Extension

Woolsey Pharmaceuticals has announced the successful completion of an extension to its Series B Preferred financing round, receiving substantial backing from existing investors. This crucial funding is set to bolster the company’s ambitious efforts to advance BRAVYL, their investigational drug for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Sven Jacobson, CEO of Woolsey Pharmaceuticals, expressed gratitude for the unwavering support from investors, saying, "We are immensely grateful for the continued support of our investors and remain steadfast and confident in our mission to advance BRAVYL® for the treatment of ALS." The funds are expected to help the company meet critical developmental milestones as it pushes forward with clinical trials.

Progress in Clinical Trials

In the fourth quarter of 2024, Woolsey completed enrollment in the high-dose cohort of its REAL study, where BRAVYL (oral fasudil) is being tested on patients with ALS. This trial follows promising results from an earlier, standard-dose cohort, showing a noteworthy decrease in the biomarker Neurofilament Light (NfL), which serves as an indicator of neuronal damage and ALS progression. The results from the 180 mg/day dose group indicated a significant 15% decline in NfL levels over six months, alongside a relative improvement in patient functionality as measured by the ALSFRS-R.

Additionally, positive clinical results in this cohort suggested a 17% slower decline rate in ALSFRS-R scores and a substantial decrease in muscle strength and lung capacity deterioration in treated patients compared to historical control groups.

Insights into Mechanisms

The company also highlighted notable findings from a separate experiment involving mouse motor-neuron cells, demonstrating how treatments with BRAVYL appeared to significantly impede the aggregation and redistribution of TDP-43, a toxic protein associated with ALS pathology. In contrast to untreated neuron-derived exosomes from ALS patients, exosomes from patients who had undergone BRAVYL treatment exhibited a dramatic reduction in TDP-43 aggregation and cytoplasmic distribution, underscoring the potential therapeutic impact of the drug.

Patents and Future Innovations

Woolsey Pharmaceuticals maintains significant patent protections for BRAVYL, having filed a total of 36 patent families. Notably, U.S. patent 11,779,588 protects the application of oral fasudil in treating disease progression in ALS, while other patents focus on formulations that are easier to swallow - an important consideration for ALS patients with dysphagia.

The U.S. Patent and Trademark Office also recently granted additional claims for BRAVYL’s use, reinforcing the drug's potential in treating various classifications of ALS. Furthermore, the company has obtained Orphan Drug Designation for BRAVYL in both the U.S. and Europe, facilitating accelerated development and market access for this crucial treatment.

The Importance of Advances in ALS Treatment

ALS is a devastating neurodegenerative disease that typically leads to a rapid decline in patient health, with a mean survival time of only two to five years post-diagnosis. The emergence and advancement of therapies like BRAVYL could revolutionize the treatment landscape, providing both hope and improved quality of life for those affected by this challenging condition.

As Woolsey Pharmaceuticals continues its journey, the successful completion of their Series B extension signals a promising opportunity to enhance their treatment offerings and potentially change the course of ALS management in the near future.

In anticipation of upcoming clinical data reads, the industry watches closely as Woolsey navigates the intricacies of drug development and continues its mission to improve the lives of patients with neurodegenerative diseases.