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Satellos Bioscience Announces Evidence for Regeneration in Severe Model of Duchenne

·6 min read

Toronto, Ontario--(Newsfile Corp. - September 13, 2021) - Satellos Bioscience Inc. (TSXV: MSCL) ("Satellos"), a regenerative medicine company focused on the treatment of degenerative muscle disorders, announced today core findings from additional preclinical drug development studies in their lead program to treat Duchenne muscular dystrophy ("Duchenne").

Satellos scientists are developing small molecule drugs with the goal of restoring faulty regeneration and repair observed in the muscles of patients with Duchenne and potentially other degenerative and age-related muscle disorders. The company's drug candidates for Duchenne target an enzyme, codenamed PTP-X, which Satellos discovered is involved in regulating muscle stem cell divisions. Based on preclinical research studies conducted by Satellos, modulating PTP-X with drug has the capacity to create functional muscle fibres in a mouse bearing the same genetic loss of dystrophin as seen in Duchenne. This breakthrough offers the prospect for an entirely new therapeutic approach to repairing the debilitating tissue damage which accumulates in the muscles of Duchenne patients.

"In our latest preclinical studies, we again observed significant improvements in the ambulation of drug treated mice, confirming and extending earlier work we have done -- which is so very important to validate and build confidence in our unique therapeutic approach," said Frank Gleeson, co-founder and CEO of Satellos. "An additional noteworthy finding from the study was further evidence for the potential utility of a novel biomarker of muscle regeneration, an important development milestone for Satellos." Added Mr. Gleeson, "a validated biomarker would improve our capacity to predict the efficacy of our treatments in patients during clinical trials, offering the prospect of speedier regulatory approvals with our prospective drug candidates."

Satellos conducted these preclinical studies using a disease model of Duchenne that is more severe than the industry standard Mdx mouse, called the Mdx DBA/2J. The mice were treated with a Satellos drug candidate for a period of 4 weeks and then analyzed across a range of measures. Drug treated mice displayed significantly increased running speed and distance travelled on a voluntary running wheel as well as increased expression of a candidate biomarker of muscle regeneration. "We are excited by these results. We believe it is imperative that we continue to construct a broad body of evidence demonstrating that muscle regeneration and repair in Duchenne is not only feasible but more critically, that the resultant muscle fibres are functional - a long-desired therapeutic goal which has been so elusive with many prior approaches," said Dr. Michael Rudnicki, PhD, FRS, OC, co-founder and CSO of Satellos.

About Satellos

Satellos is a regenerative medicine company dedicated to developing novel therapeutics that stimulate or restore muscle regeneration in severe disorders. Satellos was founded on the discovery that dysregulated muscle stem-cell polarity - a process that balances replenishment of muscle stem cells and production of specialized tissue cells- can lead to the inability of the body to properly repair and regenerate muscle throughout life. Satellos' lead program is focused on developing an oral therapeutic drug for Duchenne muscular dystrophy that serves to correct this dysregulation which Satellos has identified as a root cause of the progressive nature of this disease. Satellos believes defects in muscle regeneration play a critical underlying role in numerous muscle disorders spanning rare diseases through to mass market indications. Accordingly, Satellos applies its proprietary discovery platform, MyoReGenXTM, to identify regulatory pathways and drug candidates to treat muscle disorders where stem cell polarity is dysregulated. Satellos also maintains the rights to two clinical stage legacy assets as a result of the reverse takeover of iCo Therapeutics Inc. Founded in 2018, Satellos is headquartered in Canada. For more information about Satellos' regenerative therapeutic discovery platform, development programs, or licensing opportunities for iCo legacy assets please contact Ryan Mitchell, PhD, Director - Business Development @rmitchell@satellos.com or visit Satellos.com.

For more information about Satellos contact:
Frank Gleeson
President and Chief Executive Officer
fgleeson@satellos.com
647.660.1780

About Duchenne

Duchenne muscular dystrophy ("Duchenne") is a fatal genetic disease that slowly and progressively robs people of their muscle strength and function. Diagnosed in childhood, affecting approximately one in 5,000 live male births, Duchenne is caused by a change in the dystrophin gene. In people living with Duchenne, it was discovered by Dr. Michael Rudnicki, the scientific founder of Satellos, that muscle stem cells are severely compromised in their ability to create muscle progenitor cells which repair injured muscle. As a result, people with Duchenne are unable to keep up with the continuous damage to their muscles throughout life.

THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY ANY SECURITIES IN ANY JURISDICTION, NOR SHALL THERE BE ANY OFFER, SALE, OR SOLICITATION OF SECURITIES IN ANY JURISDICTION IN WHICH SUCH OFFER, SALE, OR SOLICITATION WOULD BE UNLAWFUL.

THE SECURITIES ISSUED IN CONNECTION WITH THE ARRANGEMENT AND CONCURRENT FINANCING HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933 (THE "1933 ACT') AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES OR TO A U.S. PERSON IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE 1933 ACT. THE RESULTING ISSUER INTENDS TO ISSUE SUCH SECURITIES PURSUANT TO THE EXEMPTION FROM REGISTRATION SET FORTH IN SECTION 3(A)(10) OF THE 1933 ACT.

Notice on forward-looking statements:

This release includes forward-looking information or forward-looking statements within the meaning of Canadian securities laws, the 1933 Act, the U.S. Securities TSXV Act of 1934 and the U.S. Private Securities Litigation Reform Act of 1995 regarding Satellos and its business, which may include, but are not limited to, statements with respect to the ability to obtain regulatory approvals, the final approval of the TSXV and issuance of the final exchange bulletin, the use of proceeds from the Concurrent Financing, Satellos' technologies and drug development plans, the timeline to commence clinical trial testing in humans and evaluation plans for drug molecules, the timeline for Satellos Shares to resume trading. Often but not always, forward-looking information can be identified by the use of words such as "expect", "intends", "anticipated", "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may', "could", "would" or "will" be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of each entity, and are based on assumptions and subject to risks and uncertainties. Although the management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, market conditions, economic factors, management's ability to manage and to operate the business of the company and the equity markets generally. Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

NOT FOR DISSEMINATION IN THE UNITED STATES OR FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/96171