MIAMI, FL, July 29, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced the company will be participating in one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference on August 5th, 2024.
About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of calendar year 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.
About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.
About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a "starvation state" where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced appetite suppression provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.
Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.
Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.
Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.
The Company also has an FDA-approved commercial product, the FC2 Female Condom (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company's scientific advisors will make valuable contributions to the Company's enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company's product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company's existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company's products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company's ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company's U.S. prescription business could cause significant quarter-to-quarter variations in the Company's operating results and adversely affect its net revenues and gross profit; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company's production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company's and third party manufacturing facilities and/or of the Company's ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company's and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the "SEC Filings" section of our website at .
* Wegovy is a registered trademark of Novo Nordisk A/S
Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
2024年7月29日、フロリダ州マイアミ─ベル(NASDAQ:VERU)は、筋肉を維持する画期的な医薬品を開発することに特化した後期臨床段階のバイオ医薬品企業であり、高品質の減量、がん、ウイルス誘発性急性呼吸窮迫症候群の革新的な薬剤の開発に注力しています。同社は、2024年8月5日に開催されるBTIG Virtual Biotechnology Conferenceで投資家との一対一の会合に参加することを発表しました。
Enobosarm第2b相臨床試験について
第20分野、多施設、二重盲検、プラセボ対照、無作為化、用量検索の臨床試験は、セマグルチド(Wegovy)を受け取る肥満または過体重の高齢者(60歳以上)患者または筋肉質肥満の約150人の患者を対象として、エノボサルム3mg、エノボサルム6mg、またはプラセボを筋肉を維持し、脂肪減少を増強する治療法として評価するために設計されています。主要評価項目は総体脂肪量であり、主要二次評価項目は16週間のステアクライムテストによる身体機能と全体瘦体組織量です。第20分野臨床試験は、15の臨床施設からアメリカで患者を積極的に募集しています。この試験のトップラインの臨床結果は、2024年のカレンダー年末までに発表される予定です。
第20分野臨床試験の有効用量の検索部分を完了した後、全ての患者がGLP-1 RAの投与を中止し、プラセボ、エノボサルム3mg、またはエノボサルム6mgのいずれかを追加の12週間服用する第20分野の拡大臨床試験に盲検法で継続して参加することが予想されています。第20分野拡大臨床試験は、エノボサルムがGLP-1 RAの中止後に生じる脂肪および体重増加を防止し、筋肉を維持できるかを評価します。この独立した第20分野盲検のトップライン結果は、2025年の第2四半期に発表される予定です。
筋肉減少性肥満について
米国では、41.5%の高齢者が肥満であり、減量薬の恩恵を受けることができます。これらの肥満患者のうち、60歳以上の肥満と筋肉萎縮症がある患者の割合は34.4%に上ります。この大きなサブポピュレーションの筋肉障害性肥満患者は、年齢による筋肉量の減少のため、脂肪減少薬のGLP-1を摂取する際にリスクが高いです。GLP-1 RA薬剤を服用するときに筋肉量がさらに減少すると、筋肉の弱さ、バランスの悪化、歩行速度の低下、移動障害、自立の喪失、転倒、骨折、増加した死亡率などが発生するため、年齢関連の虚弱性のような状態になります。 GLP-1 RA治療中の筋肉量の減少の程度と速度のため、GLP-1 RA薬剤は、高齢の肥満または過重の高齢患者で脆弱性の発症を加速する可能性があります。
エノボサルムについて
エノボサルム(別名オスタリン、Mk-2866、GTx-024、ベル-024)は、口から摂取する新しい選択的アンドロゲン受容体調節剤(SARM)で、高齢の男性および閉経後の女性、および進行がんの筋肉消耗のための多くの患者を対象に、5つの臨床試験で事前に研究されています。進行がんは、GLP-1 RA薬を服用している患者と同様に、筋肉と脂肪の大幅な意図しない消耗または消失があり、これにより、「栄養失調状態」が想定されます。過去の5つのエノボサルム臨床試験から得られた患者データは、エノボサルム治療が筋肉質量の用量依存性の増加を引き起こし、身体機能の改善だけでなく、脂質量の用量依存性の減少をもたらすことを明示しています。これらのエノボサルム臨床試験で得られた高齢患者とがん誘引食欲低下の患者から生成された患者データは、エノボサルムの有力な臨床根拠を提供すると考えられています。GLP-1 RAとの組み合わせによって、体重減少が増強され、筋肉質量は維持されると期待されます。
重要なことに、エノボサルムには、1581人の男性と女性を対象とした27件の臨床試験を含む大規模な安全性データベースがあり、中には3年間投与された患者もいました。この大規模な安全性データベースでは、エノボサルムは一般的に胃腸の副作用が増加することはありませんでした。これは、GLP-1 RA単独治療で既に重篤で頻繁な胃腸の副作用があることが重要です。
ベルについて
ベルは、代謝性疾患、腫瘍学及びARDSの治療に新しい薬剤を開発することに注力している遅期臨床段階のバイオファーマ企業です。同社の薬剤開発プログラムには、2つの後期の新しい小分子薬剤、エノボサルムとサビザブリンが含まれています。
エノボサルムは、2つの適応症で開発されています:(i)GLP-1 RAを受け取る筋肉質肥満または過体重の高齢患者における脂肪減少増強と筋肉消失予防の治療としての第20分野臨床試験(ii)十分な資金調達が可能であれば、アンドロゲン受容体陽性(AR+)、エストロゲン受容体陽性(ER+)およびヒト表皮成長因子受容体2陰性(HER2-)の2次治療におけるアベマシクリブとエノボサルムの第3相ENABLAR-2臨床試験。
サビザブリンは、マイクロチューブル破壊剤であり、ウイルス性ARDSを発病した入院患者の治療のための第3相臨床試験として開発されています。同社は、政府補助金、製薬会社とのパートナーシップ、またはその他の類似するサードパーティーの外部資金調達を得るまで、サビザブリンのさらなる開発を行う予定はありません。
同社には、FDA承認済みの商用製品であるFC2女性用コンドーム(内用コンドーム)があり、予防妊娠と性感染症の両方を防止することができます。
出典:Nutex Health, Inc。
このプレスリリースには、「前向きな声明」という用語が、1995年の私的証券訴訟改革法に定義された通りに含まれており、上で議論されたエノボサルムの第20分野試験がトップラインデータを生産し、患者が拡張研究に進むかどうか、そのような試験の計画された設計、サイト数、タイミング、エンドポイント、患者集団、および患者数を含め、エノボサルムが肥満患者では減量を増強するか、または筋肉を維持し、または何らかの未解決のニーズを満たすか、体重減少が増強されるか、会社の科学的アドバイザーが同社のエノボサルムプログラムに有益な貢献をするか、同社が肥満とがんに特化した後期臨床段階のバイオ医薬品企業に変身することに成功するかどうかについて、明示または暗示的に述べられています。ただし、前向きな声明にはこれらの識別用語が含まれるとは限らず、すべての前向きな声明がこれらの識別用語を含むわけではありません。このプレスリリースの前向きな声明は、会社の現在の計画と戦略に基づいており、会社のビジネスに関連するリスクと不確実性の現在の評価を反映しており、このプレスリリースの日付をもってそのまま作成されていると見なされます。このプレスリリースのいずれかの前向きな声明の更新を行う義務を負うものではありません。これらの前向きな声明は、既知のリスク、不確実性、仮定に対してサブジェクトであり、リスクまたは不確実性のいずれかが発生した場合、または仮定のいずれかが正しくなかった場合、実際の結果がこのような声明によって示唆されているように表明または暗示された結果と異なる可能性があります。実際の結果がこれらの前向きな声明によって示唆されているようにはならない可能性があります。
* Wegovyは、Novo Nordisk A / Sの登録商標です。
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Email: veruinvestor@verupharma.com