Mannkind, Game-Chancer in Sachen Diabetik? (Seite 6)
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Beitrag zu dieser Diskussion schreiben
Die 5,63$ sind eine Wand und die Entwicklungen von z.B. Sernova bewegen sich auch immer weiter---also Vorsicht ist besser als Nachsicht
Mnkd
+ 20 %, ich rieche burned shorts und das ist erst der Anfang, Mnkd ist mit UTHR bald eine cash cow und wird Zweistellig übernommen, ratet mal von wem, UTHR, US 15! Mannkind
MannKind (MNKD) PT Raised to $7.50 at Cantor Fitzgerald
und ich vergass was machen die shorts
es gibt reichlich s
shorts
dürfem wir auf einen squeeze hoffen ?
es gibt reichlich s
shorts
dürfem wir auf einen squeeze hoffen ?
bald dürfte mnkd ( nächstes Quartal ) in die Gewinnzone drehen
Mnkd
Wow, Mannkind übertrifft die Erwartungen um Meilen, 157 % revenues Steigerung gegenüber letztem Jahr, cash flow positiv....short squeeeeeeeeeeeeeeezeeeeeeeeeeeeeee steht vor der Tür:MannKind Corporation Reports 2023 Second Quarter Financial Results
MannKind
Mon, August 7, 2023 at 10:00 PM GMT+2
In this article:
MNKD
-2.5424%
Watchlist
Performance Outlookyahoo plus badge
2W-6W
6W-9M
9M+
MannKind
MannKind
Conference Call to Begin Today at 5:00 p.m. (ET)
2Q 2023 Total revenues of $49M; +157% vs. 2Q 2022
2Q 2023 Tyvaso DPI royalties of $19M; +63% vs. 1Q 2023
2Q 2023 Endocrine Business Unit net revenues of $18M; Afrezza net revenues +27% vs. 2Q 2022
2Q 2023 Income from operations of $2M; Non-GAAP income from operations of $8M
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended June 30, 2023.
“We are excited to report positive income from operations in the second quarter driven by growing patient demand for Tyvaso DPI® and Afrezza as well as manufacturing revenues from Tyvaso DPI,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “In addition, we have optimized our commercial operations supporting Afrezza® and V-Go®, which is expected to get our Endocrine Business Unit to profitability starting in 2024.”
Second Quarter 2023 Results
Revenue Highlights
Three Months
Ended June 30,
2023
2022
$ Change
% Change
(Dollars in thousands)
Net revenue – Afrezza
$
13,527
$
10,649
$
2,878
27
%
Net revenue – V-Go
4,818
2,073
$
2,745
*
Revenue – collaborations and services
11,211
5,868
$
5,343
91
%
Royalties – collaborations
19,055
304
$
18,751
*
Total revenues
$
48,611
$
18,894
$
29,717
157
%
________________________
* Not meaningful
Afrezza net revenue for the second quarter of 2023 increased $2.9 million, or 27%, compared to the same period in 2022 as a result of higher product demand and price. V-Go was acquired in the second quarter of 2022 and achieved $22.0 million in cumulative net revenues one year post-acquisition, which was at the high end of our forecasted range. The increase in collaborations and services revenue was primarily attributable to revenues associated with the commercial supply agreement (the "CSA") with United Therapeutics ("UT"). In the second quarter of 2022, revenue associated with the CSA was deferred until we began commercial manufacturing and subsequently selling Tyvaso DPI in June 2022. Royalties related to Tyvaso DPI, launched in late second quarter of 2022 by UT, were $19.0 million in the second quarter of 2023 and continued to grow based on strong patient demand.
Commercial product gross margin in the second quarter of 2023 was 72% compared to 64% for the same period in 2022, primarily attributable to an increase in Afrezza net revenue, which has a higher gross margin than V-Go.
Cost of revenue – collaborations and services for the second quarter of 2023 was $9.0 million compared to $8.3 million for the same period in 2022, an increase of $0.7 million, due to an increase in manufacturing activities for Tyvaso DPI.
Research and development ("R&D") expenses for the second quarter of 2023 were $6.5 million compared to $4.9 million for the same period in 2022. The $1.6 million increase was primarily attributed to development activities for MNKD-101 (inhaled clofazimine) and an Afrezza post-marketing clinical study (INHALE-3), which commenced in the second quarter of 2023.
Selling expenses for the second quarter of 2023 were $14.0 million compared to $15.9 million for the same period in 2022. The $1.9 million decrease was primarily attributable to the termination of an Afrezza pilot promotional effort targeting primary care physicians, which ended in the third quarter of 2022, partially offset by increased headcount after the acquisition of V-Go in the second quarter of 2022.
General and administrative expenses for the second quarter of 2023 were $11.9 million compared to $10.2 million for the same period in 2022. The $1.8 million increase was primarily attributable to higher stock-based compensation and increased headcount.
Interest income was $1.5 million for the second quarter of 2023 compared to $0.5 million for the same period in 2022. The increase was primarily due to higher yields on our marketable securities and money market funds.
Interest expense on financing liability was $2.4 million for the second quarter of 2023 and remained consistent with the same period in 2022.
Interest expense was $6.9 million in the second quarter of 2023 compared to $6.6 million for the same period in 2022, which remained consistent due to fixed interest rates on notes and consistent recognition of interest expense related to the achievement of Afrezza milestones.
Gain on available-for-sale securities for the second quarter of 2023 was $0.9 million as a result of the change in the fair value of the investment that related to credit risk.
First half of 2023
Revenue Highlights
Six Months
Ended June 30,
2023
2022
$ Change
% Change
Net revenue — Afrezza
$
25,951
$
20,475
$
5,476
27
%
Net revenue — V-Go
9,956
2,073
$
7,883
*
Revenue — collaborations and services
22,597
8,034
$
14,563
181
%
Royalties — collaborations
30,733
304
$
30,429
*
Total revenues
$
89,237
$
30,886
$
58,351
189
%
________________________
* Not meaningful
Afrezza net revenue for the first half of 2023 increased $5.5 million, or 27%, compared to the same period in 2022 primarily as a result of higher product demand and price. V-Go was acquired in the second quarter of 2022 and achieved $22.0 million in net revenues one year post-acquisition, which was at the high end of our forecasted range. The increase in collaborations and services revenue was primarily attributable to the deferral of revenue associated with the CSA until we began commercial manufacturing and subsequently selling Tyvaso DPI in June 2022. Royalties related to Tyvaso DPI, launched in the late second quarter of 2022 by UT, reached $30.7 million in the first half of 2023 based on strong patient demand.
Commercial product gross margin in the first half of 2023 was 70%, which was consistent with the same period in 2022.
Cost of revenue – collaborations and services for the first half of 2023 was $19.7 million compared to $17.0 million for the same period in 2022, an increase of $2.7 million, due to an increase in manufacturing activities for Tyvaso DPI.
R&D expenses for the first half of 2023 were $12.1 million compared to $8.4 million for the same period in 2022. The $3.6 million increase was primarily attributed to development activities for MNKD-101 and INHALE-3.
Selling expenses for the first half of 2023 were $27.3 million compared to $28.6 million for the same period in 2022. The $1.3 million decrease was primarily due to the termination of an Afrezza pilot promotional effort targeting primary care physicians, which ended in the third quarter of 2022, partially offset by increased headcount and promotional expenses after the acquisition of V-Go in the second quarter of 2022.
General and administrative expenses for the first half of 2023 were $22.5 million compared to $18.1 million for the same period in 2022. The $4.3 million increase was primarily attributable to higher stock-based compensation and increased headcount.
Interest income was $2.8 million for the six months ended June 30, 2023 compared to $0.9 million for the same period in 2022. The increase was primarily due to higher yields on our marketable securities and money market funds.
Interest expense on financing liability was $4.9 million for the first half of 2023 and remained consistent with the same period in 2022.
Interest expense on notes was $9.7 million in the first half of 2023 compared to $9.4 million for the same period in 2022, which remained consistent due to fixed interest rates on notes and consistent recognition of interest expense related to the achievement of Afrezza milestones.
Gain on available-for-sale securities for the first half of 2023 was $0.9 million as a result of the change in the fair value of the investment that related to credit risk.
Cash, cash equivalents and investments as of June 30, 2023 were $146.6 million.
Non-GAAP Measures
To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting non-GAAP income (loss) from operations, non-GAAP net loss and non-GAAP net income (loss) per share, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.
These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following tables reconcile our financial measure for income (loss) from operations, net loss and earnings (loss) per share ("EPS") for basic and diluted weighted average shares as reported in our condensed consolidated statement of operations to a non-GAAP presentation as adjusted for the non-cash stock-based compensation expense and non-cash gain (loss) on foreign currency transactions for the periods presented:
Three Months
Six Months
Ended June 30,
Ended June 30,
2023
2022
2023
2022
(In thousands except per share data)
GAAP Income (loss) from operations
$
1,721
$
(20,454
)
$
(4,277
)
$
(41,710
)
Increase (decrease) for excluded non-cash items:
Stock compensation
5,580
4,422
9,235
7,228
Loss (gain) on foreign currency transaction
251
(4,503
)
1,205
(6,486
)
Non-GAAP income (loss) from operations
$
7,552
$
(20,535
)
$
6,163
$
(40,968
)
GAAP net loss
$
(5,265
)
$
(29,023
)
$
(15,060
)
$
(55,021
)
Increase (decrease) for excluded non-cash items:
Stock compensation
5,580
4,422
9,235
7,228
Loss (gain) on foreign currency transaction
251
(4,503
)
1,205
(6,486
)
Gain on available-for-sale securities
(932
)
—
(932
)
—
Non-GAAP net loss
$
(366
)
$
(29,104
)
$
(5,552
)
$
(54,279
)
GAAP net loss per share - basic and diluted
$
(0.02
)
$
(0.11
)
$
(0.06
)
$
(0.22
)
Increase (decrease) for excluded non-cash items:
Stock compensation
0.02
0.02
0.03
0.03
Loss (gain) on foreign currency transaction
0.00
(0.02
)
0.00
(0.03
)
Gain on available-for-sale securities
0.00
0.00
0.00
0.00
Non-GAAP net loss per share - basic and diluted
$
0.00
$
(0.11
)
$
(0.03
)
$
(0.22
)
Weighted average shares - basic and diluted
265,626
253,644
264,802
252,775
Conference Call
MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, Twitter or Instagram.
Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the optimization of our commercial operations for Afrezza and V-Go and the potential for our Endocrine Business Unit to reach profitability starting in 2024. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply, risks associated with product commercialization, risks associated with developing product candidates, risks associated with MannKind’s ability to manage its existing cash resources or raise additional cash resources, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 23, 2023, and under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
Tyvaso DPI is a trademark of United Therapeutics Corporation.
AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.
MannKind Contact:
Rose Alinaya, Investor Relations
(818) 661-5000
IR@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months
Ended June 30,
Six Months
Ended June 30,
2023
2022
2023
2022
(In thousands except per share data)
Revenues:
Net revenue – commercial product sales
$
18,345
$
12,722
$
35,907
$
22,548
Revenue – collaborations and services
11,211
5,868
22,597
8,034
Royalties – collaborations
19,055
304
30,733
304
Total revenues
48,611
18,894
89,237
30,886
Expenses:
Cost of goods sold
5,224
4,617
10,754
6,901
Cost of revenue – collaborations and services
9,013
8,298
19,696
17,012
Research and development
6,453
4,893
12,058
8,429
Selling
14,002
15,868
27,312
28,596
General and administrative
11,947
10,175
22,489
18,144
Loss (gain) on foreign currency transaction
251
(4,503
)
1,205
(6,486
)
Total expenses
46,890
39,348
93,514
72,596
Income (loss) from operations
1,721
(20,454
)
(4,277
)
(41,710
)
Other income (expense):
Interest income, net
1,547
516
2,849
893
Interest expense on financing liability
(2,449
)
(2,443
)
(4,873
)
(4,814
)
Interest expense
(6,873
)
(6,642
)
(9,659
)
(9,390
)
Gain on available-for-sale securities
932
—
932
—
Other expense
(143
)
—
(32
)
—
Total other expense
(6,986
)
(8,569
)
(10,783
)
(13,311
)
Loss before income tax expense
(5,265
)
(29,023
)
(15,060
)
(55,021
)
Benefit from income taxes
—
—
—
—
Net loss
$
(5,265
)
$
(29,023
)
$
(15,060
)
$
(55,021
)
Net loss per share – basic and diluted
$
(0.02
)
$
(0.11
)
$
(0.06
)
$
(0.22
)
Weighted average shares used to compute net loss per share – basic and diluted
265,626
253,644
264,802
252,775
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2023
December 31, 2022
(In thousands except share
and per share data)
ASSETS
Current assets:
Cash and cash equivalents
$
86,184
$
69,767
Short-term investments
58,163
101,079
Accounts receivable, net
27,789
16,801
Inventory
25,290
21,772
Prepaid expenses and other current assets
32,807
25,477
Total current assets
230,233
234,896
Property and equipment, net
69,510
45,126
Goodwill
1,931
2,428
Other intangible asset
1,113
1,153
Long-term investments
2,282
1,961
Other assets
8,353
9,718
Total assets
$
313,422
$
295,282
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable
$
17,127
$
11,052
Accrued expenses and other current liabilities
36,833
35,553
Financing liability – current
9,686
9,565
Midcap credit facility – current
16,667
—
Deferred revenue – current
3,489
1,733
Recognized loss on purchase commitments – current
13,164
9,393
Total current liabilities
96,966
67,296
Mann Group convertible note
8,829
8,829
Accrued interest – Mann Group convertible note
55
55
Financing liability – long term
94,395
94,512
Midcap credit facility – long term
22,811
39,264
Senior convertible notes
226,124
225,397
Recognized loss on purchase commitments – long term
56,063
62,916
Operating lease liability
4,646
5,343
Deferred revenue – long term
60,248
37,684
Milestone liabilities
3,772
4,524
Total liabilities
573,909
545,820
Stockholders' deficit:
Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2023 and December 31, 2022
—
—
Common stock, $0.01 par value – 800,000,000 and 400,000,000 shares authorized as of June 30, 2023 and December 31, 2022, respectively, and 268,235,145 and 263,793,305 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively
2,682
2,638
Additional paid-in capital
2,968,917
2,964,293
Accumulated other comprehensive income
443
—
Accumulated deficit
(3,232,529
)
(3,217,469
)
Total stockholders' deficit
(260,487
)
(250,538
)
Total liabilities and stockholders' deficit
$
313,422
$
295,282
Mannkind
Heute Q 2 Zahlen 2023 mit 100 % Steigerung der revenues gegenüber Q2 2022? Bald zweistellig!$MNKD The consensus EPS Estimate is -$0.04 (+63.6% Y/Y) and the consensus Revenue Estimate is $42.95M (+127.4% Y/Y).
Mannkind
Super Meldung für Mannkind und UTHR, unser Konkurrent Liquida bleibt wegen Patentverletzung bis 2027 vom Markt:United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation
Mon, July 24, 2023 at 5:45 PM GMT+2
In this article:
UTHR
-0.28%
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Fair Value Estimateyahoo plus badge
OvervaluedSee why
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., July 24, 2023--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.
The Federal Circuit affirmed the district court’s decision that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia and that Liquidia failed to prove any claim of that patent invalid. The ‘793 patent relates to a method of administering treprostinil via inhalation.
The Federal Circuit also affirmed the district court’s decision that certain claims of another United Therapeutics patent, U.S. Patent No. 9,593,066 (the ’066 patent), are either invalid or not infringed by Liquidia. The ’066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder.
"Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property," said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics.
Both parties have the opportunity to request rehearing by the Federal Circuit with respect to the adverse portions of the Federal Circuit’s affirmance.
Last year, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia finding all claims of the patent to be unpatentable. United Therapeutics appealed that decision to the Federal Circuit, and that appeal is pending. United Therapeutics expects that the PTAB decision will not affect the district court’s order barring FDA from granting final approval for Yutrepia unless all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals.
United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
You can learn more about what it means to be a PBC here: unither.com/PBC.
Forward-looking Statements
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding ongoing patent litigation with Liquidia, the potential timing of FDA approval for Yutrepia, and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders and furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of July 24, 2023, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.
TYVASO and TYVASO DPI are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.
YUTREPIA is a trademark of Liquidia Corporation.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230724981807/en/
Contacts
Dewey Steadman
(202) 919-4097
ir@unither.com
Neuigkeiten
veröffentlichungsdetailsMannKind startet Inhale-3-Studie, um den derzeit größten ungedeckten Bedarf bei Erwachsenen mit Typ-1-Diabetes (T1D) zu decken
22.06.23
PDF-Version
Große Studie mit Erwachsenen zum Vergleich von HbA1c und der Kontrolle zu den Mahlzeiten beim Wechsel von injizierbarem Insulin oder Pumpen zu inhaliertem Insulin (Afrezza® ( Insulin Human) Inhalationspulver)
Trotz der Fortschritte in der Diabetes-Technologie bleibt die Einhaltung der Zeitspanne während der Wachstunden eine Herausforderung
Mangelnde Kontrolle der Essenszeit ist das zugrunde liegende Problem, das etwa 80 % (1) der T1D-Bevölkerung daran hindert, das HbA1c-Ziel zu erreichen
DANBURY, Conn.UndWESTLAKE VILLAGE, Kalifornien.,22. Juni 2023 (GLOBE NEWSWIRE) --MannKind Corporation(Nasdaq: MNKD) , ein Unternehmen, das sich auf die Entwicklung und Vermarktung von inhalativen therapeutischen Produkten und Geräten für Patienten mit endokrinen und seltenen Lungenerkrankungen konzentriert, gab heute bekannt, dass es die INHALE-3-Studie startet, um den derzeit größten ungedeckten Bedarf bei Erwachsenen zu decken Leben mit T1D.
„Diese große Studie ist geplant, um die Verbesserung der Blutzuckerkontrolle zu den Mahlzeiten zu bewerten, die für die Mehrheit der Menschen mit Typ-1-Diabetes weiterhin eine große Herausforderung darstellt“, sagte erMichael Castagna, PharmD, Chief Executive Officer vonMannKind Corporation. „INHALE-3 wird die Wirkung von Afrezza auf die Kontrolle der Essenszeit untersuchen, das ein Zeitwirkungsprofil aufweist, das dem von physiologischem Insulin in den ersten 120 Minuten nach einer Mahlzeit sehr ähnlich ist.“
INHALE-3 ist eine 17-wöchige randomisierte kontrollierte Studie mit einer Verlängerung um 13 Wochen. Im Rahmen der Studie werden Teilnehmer über 18 Jahren mit Typ-1-Diabetes, die MDI, ein automatisiertes Insulinabgabesystem (AID) oder eine Pumpe ohne Automatisierung verwenden, nach dem Zufallsprinzip ausgewählt, um entweder ihre übliche Pflege fortzusetzen oder eine Insulinkur mit Basalinjektionen plus Afrezza einzuführen. In beiden Armen wird eine kontinuierliche Glukoseüberwachung zur Beurteilung der Mahlzeitenkontrolle und der A1c-Werte eingesetzt.
„Menschen mit Diabetes verdienen Optionen und Innovationen, die Belastungen reduzieren und eine wirksame Glukosekontrolle ermöglichen können“, sagte Dr.Irl B. Hirsch, Professor für Medizin und Diabetesbehandlung und Lehrstuhlinhaber an derUniversität von Washington. „Als Protokollleiter der INHALE-3-Studie freue ich mich darauf, mit führenden klinischen Standorten im ganzen Land zusammenzuarbeiten, um aussagekräftige Daten zur Verwendung von inhaliertem Insulin zu sammeln.“
Ungefähr 120 Patienten werden in der Studie, die in Zusammenarbeit mit dem durchgeführt wird, randomisiertJaeb-Zentrum für Gesundheitsforschungund 20 Standorte im ganzen Land, darunter dieJoslin Diabetes Center, DieBarbara Davis Center für Diabetes, DieDiabetes-Institut der Universität Washington,Nordwestliche Universität,Mayo-Klinik, UndDiabetes Care Center der University of North Carolina.
Weitere Informationen zu INHALE-3 und die Liste der teilnehmenden Standorte finden Sie unter: https://clinicaltrials.gov/ct2/show/NCT05904743 .
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