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|Item 7.01|| |
Regulation FD Disclosure.
Chiasma, Inc.’s management will host a conference call and webcast to discuss top-line results from its international Phase 3 clinical trial, referred to as the “MPOWERED” (Maintenance of Acromegaly Patients with Octreotide Capsules Compared With Injections - Evaluation of REsponse Durability), of MYCAPSSA® (octreotide capsules) for the maintenance treatment of adult patients with acromegaly on Wednesday, November 18, 2020 at 8:00 a.m. ET. A copy of the slide deck accompanying such presentation is being furnished as Exhibit 99.1, which is incorporated herein by reference.
The information set forth in Item 7.01 and Exhibit 99.1 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|Item 8.01|| |
On November 18, 2020, Chiasma, Inc. issued a press release announcing top-line results from the MPOWERED trial of MYCAPSSA® for the maintenance treatment of adult patients with acromegaly. A copy of the press release is attached hereto as Exhibit 99.2 hereto and is incorporated herein by reference.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Investor presentation furnished by Chiasma, Inc.|
|99.2||Press Release issued by Chiasma, Inc. dated November 18, 2020.|
|104||Cover Page Interactive Data File.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: November 18, 2020||Chiasma, Inc.|
Phase 3 MPOWEREDTM Trial Top-line Results November 18, 2020 Exhibit 99.1
These slides and the accompanying presentation contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. These statements include, without limitation, those statements regarding the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, statements regarding the timing of an MAA submission and regulatory review, statements regarding the company’s plans for the presentation of the full trial results, statements regarding the company’s expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements concerning the therapeutic potential of MYCAPSSA, including its ability to become a standard of care, statements regarding the commercialization of MYCAPSSA, including plans and strategies for potentially commercializing in the European Union and in other jurisdictions, and statements concerning the utilization of TPE platform to develop new therapeutic agents. All forward-looking statements are based on estimates and assumptions by Chiasma’s management that, although Chiasma believes them to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Chiasma expects. Management’s expectations and, therefore, any forward-looking statements in these slides and the accompanying presentation could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company’s clinical trials to obtain regulatory approval in the European Union or elsewhere, and the impact the ongoing COVID-19 pandemic may have on the company’s business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. These and other potential risks, uncertainties and other important factors are described under the heading “Risk Factors” in our Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission, or SEC, as well as in Chiasma’s subsequent filings with the SEC. Undue reliance should not be placed on any forward-looking statement, which speak only as of the date on which it was made. Chiasma undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Unless otherwise noted, all references to acromegaly market sizes are Chiasma internal estimates. This presentation is intended only for communications with investors. MYCAPSSA has been approved by the FDA for the long-term maintenance treatment in patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide, but remains an investigational drug outside the U.S. Forward-Looking Statements
MYCAPSSA is FDA Approved and is Commercially Available in the U.S. Full prescribing information available at www.MYCAPSSA.com MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Acromegaly Market Overview Octreotide and lanreotide injections are broadly used as first-line pharmacological treatments Acromegaly is a rare disease most often caused by a benign pituitary tumor and characterized by an excess of growth hormone and insulin-like growth factor-1 hormone. Treatment options include surgery, medication and radiation or a combination of these. If untreated, acromegaly may cause *Company estimate based on available data. Enlarged organs Intense headaches Altered facial appearance Enlargement of the hands and feet Type 2 diabetes Respiratory disorders Cardiac disease Joint pain Cerebrovascular disease The global market for SSAs in the treatment of acromegaly is estimated at ~$800 million with U.S. estimated at ~$400 million *
experience pain during injection; half of these experienced continuing pain days later Injections Carry Significant Treatment Burdens1 Pain Suboptimal Symptom Control Lost Workdays Emotional Impact Injection Site Reactions Hardness (48%), nodules (38%), swelling (28%), bruising (16%) and inflammation (7%) report symptoms worsen toward the end of the monthly dosing interval feel loss of independence due to chronic injections regularly miss work for injections (averages 11 days/year) 70% 52% 36% 16% 1Strasburger et al. Patient reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol. 2016 Mar;174(3):355-62.
MPOWERED Trial Positive: Met Primary Non-inferiority Endpoint MYCAPSSA (octreotide capsules) was shown to be non-inferior to long-acting injectable somatostatin analog injections (SSAs)* in maintenance of biochemical response for acromegaly patients. * Octreotide LAR and lanreotide autogel
MPOWERED Non-inferiority Study Design Last Injection Day (-28) Screening First Dose 6-Month Run-in Phase Responders Randomized to 9-Month Controlled Phase (RCT) Open Label Extension Follow for safety and efficacy 60% (55 pts) 40% (37 pts) Non-Responder Sub-study or Non-Responders Screening phase up to 4 weeks Eligibility criteria: IGF-1 <1.3 x ULN and GH<2.5 ng/mL
Higher Baseline IGF-1 Levels in the MYCAPSSA Arm Compared to Injectable SSA Arm MYCAPSSA Injectable Long-acting SSAs Total (N=55) Total (N=37) Week 26 IGF-1 (categorical) (n [%]) ≤ 1 x ULN 37 (67%) 29 (78%) > 1 to < 1.3 x ULN 12 (22%) 8 (22%) ≥ 1.3 x ULN 6 (11%) 0 (0%) Week 26 IGF-1 (ULN) Mean (SD) 0.9 (0.35) 0.8 (0.21)
MYCAPSSA is Non-inferior to Long-acting Injectable SSAs Achieved the pre-specified non-inferiority margin of -20% Primary Endpoint: IGF-1 Time Weighted Average (TWA)1 throughout the RCT phase < 1.3 x ULN 1 TWA response represents an integrated measure of efficacy across time. It is derived as the area under the curve (AUC) divided by the total amount of time under observation between the first and last IGF-1 value. MYCAPSSA (n=55) Injectable SSAs (n=37) 95% CI 95% CI Proportion of Acromegaly Patients Achieving Primary Endpoint 91% 100%
Mean IGF-1 Levels Were Maintained Within Normal Limits Baseline of RCT Baseline of RCT End of Treatment End of Treatment
MYCAPSSA Appeared to be Safe and Well Tolerated MYCAPSSA Injectable Long-acting SSAs Subjects with: n % n % At least one TEAE 39 70.9 26 70.3 Treatment-Related TEAE 19 34.5 15 40.5 SAEs 3 5.5 3 8.1 Severe TEAEs 5 9.1 4 10.8 TEAE Leading to Study Drug Discontinuation(1) 1 1.8 0 0 SAEs - Serious Adverse Events; TEAE - Treatment-Emergent Adverse Events (1) Discontinuation was determined by the applicable investigator to be unrelated to trial-related treatment.
MYCAPSSA Appeared Safe and Well Tolerated MYCAPSSA Injectable Long Acting SSAs Total (N=55) Total (N=37) Gastrointestinal disorders Flatulence 14 (25.5) 8 (21.6) Nausea 11 (20.0) 3 (8.1) Diarrhea 6 (10.9) 5 (13.5) Abdominal pain 5 (9.1) 3 (8.1) Constipation 3 (5.5) 5 (13.5) Infections & infestations 5 (9.1) 0 Nasopharyngitis General disorders & admin. site conditions 0 5 (13.5) Injection site nodule Nervous system disorders 5 (9.1) 1 (2.7) Headache Musculoskeletal & connective tissue disorders 5 (9.1) 2 (5.4) Arthralgia Incidence of most common TEAEs (≥ 5%) in either treatment group by patient during the RCT TEAEs higher in the injectable SSAs arm compared to MYCAPSSA were constipation and injection site nodules TEAEs higher in the MYCAPSSA arm compared to injectable SSAs were nausea, nasopharyngitis, headache and arthralgia
Chiasma Announces Positive Topline Results from the MPOWERED Phase 3 Clinical Trial Comparing MYCAPSSA® (octreotide capsules) to Long Acting Injectables for the Maintenance Treatment of Adults with Acromegaly
91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial
Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021
Company to host conference call today at 8:00 a.m. ET
Needham, MA November 18, 2020 Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced positive top-line data from its global Phase 3 MPOWERED non-inferiority clinical trial comparing MYCAPSSA® (oral octreotide capsules) to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support a planned marketing authorization application for MYCAPSSA in the European Union. MYCAPSSA is currently approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.
The MPOWERED non-inferiority trial was designed to compare long-term maintenance treatment with MYCAPSSA, the first and only approved oral SSA therapy for acromegaly, to the long-acting injectables octreotide long-acting release and lanreotide autogel, in patients previously responding to these therapies. After a six-month run-in phase, 92 patients who were responders to MYCAPSSA were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy.
The study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained insulin-like growth factor 1 (IGF-1) response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month randomized, controlled treatment (RCT) phase.
MYCAPSSA maintained mean IGF-1 within normal limits and was comparable to injectable therapy: mean IGF-1 in the MYCAPSSA cohort at the beginning and end of the RCT phase was 0.9 × ULN and 0.9 × ULN, respectively, compared to 0.8 × ULN and 0.8 × ULN, respectively, in the injectable SSA cohort.
We are excited with the positive results from the MPOWERED study that demonstrated non-inferiority relative to long-acting SSAs. These results further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients
with acromegaly, said Raj Kannan, chief executive officer of Chiasma. In light of these positive results, we plan to submit a marketing authorization application for MYCAPSSA to the European Medicines Agency in mid-2021. While we are excited to report the preliminary top line results, further analyses of the trial results are ongoing, and we plan to present the full data set from the study at upcoming medical conferences in 2021.
I am pleased that the MPOWERED study met its primary endpoint of non-inferiority compared to long acting SSA injectables. These results should provide treating physicians with confidence that patients on injectables who are switched to oral octreotide can be expected to achieve comparable efficacy and safety, commented Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, Professor of Medicine and Neurological Surgery, Director of the Pituitary Center at Oregon Health and Science University in Portland, Oregon, Immediate Past President of the Pituitary Society. Many patients with acromegaly experience significant burdens with SSA injections, including injection site pain and reactions, and I believe that the results of the MPOWERED study underscore the importance of an oral treatment alternative for patients with acromegaly.
MPOWERED MYCAPSSA® Safety:
The safety profile of MYCAPSSA capsules in the MPOWERED trial was consistent with the known safety profile of octreotide but without adverse injection site reactions. No new or unexpected safety signals were detected during the study among MYCAPSSA subjects. See Important Safety Information below for contraindications, warnings, precautions and adverse reactions associated with MYCAPSSA based in the current approved labeling in the United States.
Conference Call and Webcast Information
Chiasma management will host a conference call and webcast to discuss the results of the MPOWERED study today, November 18, 2020, at 8:00 a.m. ET. The dial-in number in the U.S. / Canada is 877-407-4018; for international participants, the dial-in number is 201-689-8471. For all callers, please refer to Conference ID 13713200. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=142448
A live audio webcast of the call may also be accessed under Events & Presentations on the News & Investors section of the Companys website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Companys website approximately two hours after the event. The archived webcast will be available for one year.
MPOWERED Phase 3 Trial Design
The MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients who were deemed responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules (n=55) or injectable somatostatin receptor ligands (octreotide long-acting release or lanreotide autogel) (n=37), and then followed for an additional nine months. The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with leading injectable somatostatin analogs.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
Advise premenopausal females of the potential for an unintended pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.
Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the companys website at www.chiasma.com.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, statements regarding the timing of an MAA submission and regulatory review, statements regarding the companys plans for the presentation of the full trial results, statements regarding the companys expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, and statements concerning the therapeutic potential of MYCAPSSA, including its ability to become a standard of care. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the companys control, that may cause actual events or results to differ materially from the companys current expectations. Managements expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the companys clinical trials to obtain regulatory approval in the European Union or elsewhere, and the impact the ongoing COVID-19 pandemic may have on the companys business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the companys actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Chiasmas Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the company undertakes no duty to update this information unless required by law.
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