- Completed positive End-of-Phase 2 meeting with the
- Ended second quarter 2022 with approximately
“BELLUS remains committed to bringing BLU-5937, our P2X3 antagonist product candidate, to patients burdened by RCC. This quarter, we have successfully identified a clear regulatory path to a potential approval for this candidate, bringing the Company one step closer to making this goal a reality,” commented
PROGRAM AND CORPORATE HIGHLIGHTS
Completed positive End-of-Phase 2 meeting with the FDA and received scientific advice from the EMA to support the design of its CALM Phase 3 clinical program for BLU-5937 in RCC.
- The CALM Phase 3 clinical program consists of two pivotal trials (CALM-1 and CALM-2), with primary efficacy endpoint of 24-hour cough frequency measured at 12- and 24-weeks, respectively. The Company has reached alignment with the FDA on the primary efficacy endpoint of 24H cough frequency reduction being assessed using the VitaloJAK cough monitoring system in a patient population enriched for baseline cough frequency.
- Secondary efficacy endpoints include Cough Severity using Visual Analogue Scale (CS-VAS), the Leicester Cough Questionnaire (LCQ) and Chronic Cough Diary (CCD). The CALM Phase 3 trials will also enroll participants with baseline 24H cough frequency <20 coughs/hour. A secondary efficacy endpoint will assess reduction in cough frequency in a broader population including the enriched population and additional participants with baseline 24H cough frequency below 20 coughs/hour.
- The first patient is expected to be enrolled in both CALM-1 and CALM-2 in the fourth quarter of 2022. Topline results from CALM-1 are expected in the second half of 2024.
- In addition, the Company has obtained scientific advice from the EMA and based on the feedback, it will not be making any modifications to the CALM Phase 3 program design. For additional information on the CALM-1 and CALM-2 trials designs, click here.
Completed a
-
In
July 2022 , the Company completed an offering of its common shares resulting in gross proceeds ofUS$176.0 million and net proceeds of approximatelyUS$164.5 million (the “2022 Offering”), including the full exercise of the over-allotment option.
Presented at the Twelfth London International Cough Symposium (“LICS”) and the
-
Clinical data from the Phase 2b SOOTHE trial was presented at both the 12th LICS, held in
London, England fromJuly 13-14, 2022 and the ATS 2022International Conference , held inSan Francisco, California fromMay 13-18, 2022 . The presentation materials are available in the “Scientific Publications” section ofBELLUS Health's website.
Pursuing development of its P2X3 pipeline.
-
BELLUS Health expects to initiate a Phase 1 clinical trial investigating a once-daily, extended-release formulation of BLU-5937 in the fourth quarter of 2022.
Ended the second quarter of 2022 with cash, cash equivalents and short-term investments totaling
FINANCIAL RESULTS
Cash Position: As of
Net Loss: For the quarter ended
Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to
General and Administrative (“G&A”) Expenses: General and administrative expenses amounted to
Net Finance (Costs) Income: Net finance costs amounted to
SUMMARY OF FINANCIAL RESULTS
|
Three months ended
|
Three months ended
|
||||
|
(in thousands of dollars, except per share data) |
|||||
Revenues |
US$ |
4 |
|
US$ |
4 |
|
Research and development expenses, net |
|
(12,460 |
) |
|
(15,201 |
) |
General and administrative expenses |
|
(5,379 |
) |
|
(2,805 |
) |
Net finance (costs) income |
|
(900 |
) |
|
174 |
|
Income taxes |
|
(41 |
) |
|
— |
|
Net loss for the period |
US$ |
(18,776 |
) |
US$ |
(17,828 |
) |
Basic and diluted loss per share |
US$ |
(0.18 |
) |
US$ |
(0.23 |
) |
The Company’s full unaudited consolidated financial statements and accompanying management’s discussion and analysis for the three and six-month periods ended
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist, is in development for RCC and other cough hypersensitivity indications.
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 and improve quality of life while limiting taste disturbance adverse events.
In addition to RCC, the mechanism of action of BLU-5937 may also have broad therapeutic applicability across other cough hypersensitivity indications. The Company is evaluating potential opportunities to study BLU-5937 in additional cough indications where hypersensitivity plays an important role.
About
Chronic cough is a cough lasting longer than eight weeks. When the cause of chronic cough cannot be identified or the cough persists despite treatment of all identified associated causes, the condition is referred to as RCC. It is estimated that there are approximately 9 million patients in
The Company is exploring the potential use of BLU-5937 in other patient populations experiencing cough hypersensitivity as well as other P2X3-related hypersensitization conditions.
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/20220810005750/en/
Chief Financial Officer
rbenamar@bellushealth.com
Media:
Solebury Trout
jdeutsch@soleburytrout.com
Source: