News Release Details
Bioventus Reports First Patients Enrolled in Phase 1 Clinical Trial of MOTYS™ (PTP-001) for the Treatment of Knee OA
DURHAM, N.C., March 11, 2021 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a leader in solutions for innovative healing, reported that the first patients have been enrolled and dosed in its Phase 1 open-label, dose-escalation study of MOTYS (PTP-001) with Dr. Shailesh Patel, M.D. at Coastal Carolina Research Center, South Carolina. MOTYS is a placental tissue particulate comprised of amnion, chorion and umbilical cord tissue from full-term, healthy births and is provided sterile in micronized form.
The study is evaluating the safety and efficacy of MOTYS (PTP-001) to treat osteoarthritis (OA) of the knee. Researchers are enrolling 20 patients with each patient receiving a single injection of PTP-001. Patients will be followed up to evaluate local and systemic reactions to the drug candidate, as well as to assess any improvements in pain and mobility over the course of this clinical study.
Current treatments for knee OA are limited to corticosteroids and hyaluronic acid (HA) injections. Other options to manage pain, like opioids, are associated with high risks. Bioventus is one of several market leaders in HA therapy used to treat osteoarthritis knee pain with the largest portfolio of HA products including DUROLANE®, GELSYN-3® and SUPARTZ FX® and believes products such as PTP-001, fill a need and provide more options for physicians and patients in an osteoarthritis market that is growing in scope with the aging population.
“The announcement that the first patients have been enrolled and dosed in this Phase 1 clinical study of PTP-001 is an important milestone for Bioventus especially given the challenging environment many clinical research centers are navigating due to COVID-19,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “This trial represents the first of multiple studies that Bioventus intends to conduct to demonstrate the safety and efficacy of our innovative biologic drug candidate designed to treat a prevalent, growing and debilitating condition like knee osteoarthritis, which significantly affects the quality of life of more than 14 million Americans.”
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the Company on LinkedIn and Twitter.
Bioventus, the Bioventus logo and DUROLANE are registered trademarks and Bioventus, MOTYS and GELSYN-3 are trademarks of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corp.
Summary of Indications for Use:
DUROLANE is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. Do not inject DUROLANE in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Full prescribing information can be found in package insert, at DUROLANE.com, or by contacting Bioventus Customer Service at 1-800-836-4080.
GELSYN-3 is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen). Do not administer to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Do not inject GELSYN-3 into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site. GELSYN-3 is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.GELSYN3.com or by contacting customer service at 1-800-836-4080.
SUPARTZ FX is indicated for treatment of pain in osteoarthritis (osteoarthritis) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning the MOTYS (PTP-001) study and additional intended studies, expectations regarding the safety and efficacy of our biologic drug candidate and the results and impact of Bioventus’ products. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, statements about the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the FDA; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ 424(b)(4) prospectus filed on February 12, 2021 in connection with the Company’s initial public offering, as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Mike Piccinino, CFA, IRC