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CAPRICOR THERAPEUTICS, INC.

(CAPR)
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Capricor Therapeutics Announces Positive Final Data from Its Phase 2 Hope-2 Trial in Patients with Duchenne Muscular Dystrophy Treated with Cap-1002

09/24/2021 | 07:00am EDT

Capricor Therapeutics announced positive final data from the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of Duchenne muscular dystrophy (DMD). The HOPE-2 clinical trial met its primary efficacy endpoint of mid-PUL v1.2 as well as various skeletal and cardiac endpoints suggesting clinically relevant slowing of disease progression. CAP-1002 is Capricor’s cell-based therapeutic candidate whose mechanism of action is immunomodulatory, anti-fibrotic and has been shown to regenerate skeletal and cardiac muscle cells. This final data will be presented at this year’s World Muscle Society Virtual Congress (WMS). HOPE-2 was a randomized, double-blind, placebo-controlled, Phase 2 clinical trial of the Company’s lead investigational therapy, CAP-1002, in boys and young men who have DMD and are non-ambulant, the later stage of the disease process. The trial was conducted at nine sites across the United States. Study patients were treated via intravenous delivery with either CAP-1002 (150 million cells per infusion) or placebo every 3 months. Data from a total of 20 patients was analyzed (12 placebo and 8 treated) at the 12-month time-point in the intent to treat (ITT) population. Approximately 80% of the patients were non-ambulant and all patients were on a stable regimen of steroids. Demographic and baseline characteristics were similar between the two treatment groups. Final data analysis demonstrated that young men in the advanced stages of DMD experienced improvements in skeletal and cardiac measurements after receiving four doses of CAP-1002 over the course of 1 year. Subjects in the trial were evaluated using the Performance of the Upper Limb (PUL), a validated tool specifically designed for assessing high (shoulder), mid (elbow) and distal (wrist & hand) function, with a conceptual framework reflecting the progression of weakness in upper limb function. Non-parametric mixed model repeated measures analysis with percentile ranked baseline, treatment, visit, visit-by-treatment interaction, PUL entry-item score at stratification, and site as model effects. CAP-1002 was generally safe and well tolerated throughout the study. With the exception of two hypersensitivity reactions early in the clinical trial, which were mitigated with a common pre-medication regimen, there were no serious safety signals identified by the HOPE-2 Data and Safety Monitoring Board (DSMB). These data were recently accepted at this year’s World Muscle Society Virtual Congress as a late-breaking oral presentation, due to its high-impact research findings that are of great interest to congress participants. The late-breaking results will be presented September 24, 2021. This is the second clinical trial investigating CAP-1002 showing similar results in the treatment of DMD patients. Capricor completed the HOPE-Duchenne (Phase 1/2) trial in 2019, the results of which were published in Neurology, the medical journal of the American Academy of Neurology. The Company has initiated a technology transfer with Lonza, a leading global CMO to prepare for commercial manufacturing of CAP-1002.


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Financials (USD)
Sales 2021 0,57 M - -
Net income 2021 -20,8 M - -
Net Debt 2021 - - -
P/E ratio 2021 -4,38x
Yield 2021 -
Capitalization 91,9 M 91,9 M -
Capi. / Sales 2021 160x
Capi. / Sales 2022 91,9x
Nbr of Employees 26
Free-Float 97,8%
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Last Close Price 3,99 $
Average target price 13,00 $
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Linda Marbán President, Chief Executive Officer & Director
Anthony Bergmann Chief Financial Officer
Frank Litvack Executive Chairman
Sudhir Borgonha Vice President-Clinical Development
Louis Manzo Independent Director
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