EX-99.2 3 tm2220974d1_ex99-2.htm EXHIBIT 99.2


Exhibit 99.2


FORM 51-102F3





Item1      Name and Address of Company


BELLUS Health Inc. (“BELLUS Health” or the “Company”)

275 Blvd. Armand-Frappier

Laval (Québec)

H7V 4A7


Item2      Date of Material Change


July 12, 2022


Item3      News Release


A news release was issued on July 12, 2022, and disseminated by Business Wire, in Canada and in the United States.


Item4      Summary of Material Change


BELLUS Health announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) and its CALM Phase 3 program for BLU-5937 in refractory chronic cough.


Item5      Full Description of Material Change


5.1       Full Description of Material Change


On July 12, 2022, BELLUS Health announced a positive End-of-Phase 2 (“EOP2”) meeting with the FDA and the details of the CALM Phase 3 program for BLU-5937, a highly selective, second generation P2X3 antagonist product candidate, for the treatment of refractory chronic cough (“RCC”).


Based on the FDA's feedback, the CALM Phase 3 program is composed of two pivotal trials, CALM-1 and CALM-2, each evaluating the efficacy, safety and tolerability of BLU-5937 in approximately 675 adults with RCC. CALM-1 and CALM-2 will be placebo-controlled, parallel-arm trials randomized 1:1:1 with expected treatment arms of 25 mg BID, 50 mg BID and placebo. The primary endpoint of 24H cough frequency will be measured at 12-weeks for CALM-1 and 24-weeks for CALM-2. The Company has reached alignment with the FDA that the CALM Phase 3 program’s primary endpoint, similar to the successful SOOTHE Phase 2b trial, can be assessed using the VitaloJAK cough monitoring system in a patient population enriched for baseline 24H cough frequency of ≥20 coughs/hour (equivalent to awake cough frequency of ≥25 coughs/hour used in SOOTHE Phase 2b trial). Key secondary efficacy endpoints include Cough Severity using Visual Analogue Scale, the Leicester Cough Questionnaire and Chronic Cough Diary. The CALM Phase 3 trials will also enroll participants with baseline 24H cough frequency <20 coughs/hour. A key 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. CALM-1 will have a 40-week randomized extension period and an additional 24-week open label extension. CALM-2 will have a 28-week open label extension. The trials are planned to run in parallel, and the Phase 3 CALM program is expected to enroll its first patient in the fourth quarter of 2022. Topline data from CALM-1 are expected in the second half of 2024.





The Company also terminated, on July 13, 2022, its Open Market Sale Agreement with Jefferies LLC.


5.2       Disclosure for Restructuring Transactions




Item6      Reliance on subsection 7.1(2) of National Instrument 51-102


This report is not being filed on a confidential basis.


Item7      Omitted Information




Item8      Executive Officer


For further information, please contact Ramzi Benamar, Chief Financial Officer (450) 680-4500.


Item9      Date of Report


July 13, 2022