- Announced positive findings from the Phase 2b SOOTHE trial administrative interim analysis, with at least one dose of BLU-5937 meeting the threshold for a high probability of clinical efficacy -
- Phase 2b SOOTHE and Phase 2a BLUEPRINT trials are fully enrolled, with topline results expected in
- Ended third quarter 2021 with
“We are pleased with the substantial progress we have made advancing our two ongoing Phase 2 trials this quarter, as the clinical milestones achieved for each of these trials represent important steps forward in our development strategy for our selective P2X3 antagonist, BLU-5937,” commented
PROGRAM AND CORPORATE HIGHLIGHTS
Ongoing Phase 2b SOOTHE clinical trial of BLU-5937 in patients with RCC.
-
In
September 2021 , the Company announced positive findings from a preplanned administrative interim analysis of the SOOTHE trial. A predefined stringent probability threshold for clinical efficacy was met for at least one and up to all three doses of BLU-5937 tested. Limited taste-related adverse events were observed, consistent with previous BLU-5937 trials, and no serious adverse events were reported. -
As of
September 2021 , the Company completed participant enrollment in the SOOTHE trial with a total of 310 participants with RCC enrolled, including 249 participants in the main trial and 61 in the exploratory group. -
Topline results are expected in
December 2021 . - The positive findings from the SOOTHE trial interim analysis enabled the Company to accelerate the planning for its Phase 3 program while awaiting the SOOTHE trial’s final results.
Ongoing Phase 2a BLUEPRINT clinical trial of BLU-5937 in patients with chronic pruritus associated with atopic dermatitis (“AD”).
-
As of
September 2021 , the Company completed participant enrollment in the BLUEPRINT trial, with a total of 142 participants with moderate to severe chronic pruritus associated with mild to moderate AD enrolled. -
Topline results are expected in
December 2021 .
Presented additional RELIEF data at the
-
Additional data from the Phase 2a RELIEF trial was presented in an oral presentation at ERS, which was held
September 5-8, 2021 . The presentation reviewed the observed improvements seen in cough severity and quality of life over a 16-day treatment period that favored BLU-5937.
Hosting a virtual Analyst Event to discuss the chronic cough landscape and the Company’s selective P2X3 antagonist BLU-5937.
-
On
November 15, 2021 , the Company is planning to host an Analyst Event to discuss topics including the RCC landscape, clinical development updates for BLU-5937, RCC market dynamics and P2X3 antagonist platform potential. The event will be hosted virtually, and a replay of the event will be available on the Events & Presentations page of the Company’s website.
Ended the third quarter of 2021 with cash, cash equivalents and short-term investments totaling
- Current cash position is expected to be sufficient to fund the Company’s operating plan until the end of 2022.
FINANCIAL RESULTS
Cash Position: As of
Net Loss: For the quarter ended
Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to
General and Administrative (“G&A”) Expenses: General and administrative expenses amounted to
Net Finance (Costs) Income: Net finance costs amounted to
SUMMARY OF FINANCIAL RESULTS
|
Three months ended
|
Three months ended
|
||
|
(in thousands of dollars, except per share data) |
|||
Revenues |
US$ |
4 |
US$ |
3 |
Research and development expenses, net |
|
(19,054) |
|
(5,796) |
General and administrative expenses |
|
(3,821) |
|
(456) |
Net finance (costs) income |
|
(10) |
|
540 |
Net loss for the period |
US$ |
(22,881) |
US$ |
(5,709) |
Basic and diluted loss per share |
US$ |
(0.29) |
US$ |
(0.09) |
The Company’s full unaudited condensed consolidated interim financial statements and accompanying management’s discussion and analysis for the three and nine-month periods ended
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist, is in development for RCC, chronic pruritus and other hypersensitization-related disorders.
The P2X3 receptor, which is implicated in cough reflex hypersensitization, is a rational target for treating chronic cough, and it has been evaluated in multiple clinical trials with different P2X3 antagonists. The Company believes that its highly selective P2X3 antagonist has the potential to reduce cough frequency in patients with RCC, while limiting taste disturbance adverse events.
In addition to RCC and chronic pruritus, the mechanism of action of BLU-5937 may also have broad therapeutic applicability across other afferent hypersensitization-related disorders, enabling the Company to consider BLU-5937 as a potential treatment for development in a number of other indications. Consequently,
About
RCC is a cough lasting more than 8 weeks despite appropriate treatment for underlying condition(s). It is estimated that there are approximately 9 million patients in
Chronic pruritus associated with AD is an irritating sensation that leads to scratching and persists for longer than 6 weeks in AD patients. It is estimated that up to 10% of adults in
Forward-Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations, the
Source:
View source version on businesswire.com: https://www.businesswire.com/news/home/20211110006251/en/
Chief Financial Officer
rbenamar@bellushealth.com
Media:
Solebury Trout
jdeutsch@soleburytrout.com
Source: