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Find Clinical Drug Pipeline Developments & Deals by Mannkind
Under the terms agreement, Sagard Healthcare will receive royalty payments on net sales of Tyvaso DPI (treprostinil) inhalation powder indicated for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, which is investigated in combination with insulin degludec for the treatment of type 1 diabetes.
Afrezza (human insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist and works as starts lowering blood sugars in ~12 minutes for adults living with type 1 or type 2 diabetes.
MNKD-101 (clofazimine) possesses antimicrobial and anti-inflammatory properties. It is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro. It is currently being developemnt for pulmonary nontuberculous mycobacteria.
During the MAD portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30 mg or 90 mg MNKD-101 (clofazimine) for a seven-day period.
MannKind will also publish an abstract on “Augmenting Clinical Trial Data within Silico Evidence to Evaluate Initial Conversion Dose Changes for Technosphere® Insulin (Afrezza).” The abstract will be published in category 12-E Clinical Therapeutics/New Technology – Insulins.
Studies with TYVASO (Treprostinil) establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
The proof-of-concept study demonstrated that a simplified 2x dose of Technosphere® Insulin (TI) provided significant reductions in post-prandial glucose excursions (PPGE) versus current label dosage guidelines, with no new safety concerns.
Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler.
Tyvaso DPI is drug-device combination product comprised of dry powder formulation of treprostinil Inhalation Powder. The FDA declined to approve NDA, noting only one deficiency related to open inspection issue at a third-party analytical testing center for treprostinil.