Date: 2017-12-22
Type of information: Collaboration agreement
Compound: ATL1103 - atesidorsen
Company: Antisense Therapeutics (Australia) myTomorrows (The Netherlands)
Therapeutic area: Rare diseases - Hormonal diseases - Endocrine diseases
Type agreement: collaboration
Action mechanism:
- antisense drug. ATL1103 is a second-generation antisense drug designed to block growth hormone receptor (GHr) expression thereby reducing levels of the hormone insulin-like growth factor-1 (IGF-1) in the blood and is a potential treatment for diseases associated with excessive growth hormone and IGF-1 action. These diseases include acromegaly, an abnormal growth disorder of organs, face, hands and feet, diabetic retinopathy, a common disease of the eye and a major cause of blindness, diabetic nephropathy, a common disease of the kidney and major cause of kidney failure, and some forms of cancer.
- In a Phase I study in healthy subjects, ATL1103 demonstrated a preliminary indication of drug activity, including suppression of IGF-1 and the target GHr (via circulating growth hormone binding protein) levels. In a Phase II trial in acromegalic patients, ATL1103 met its primary efficacy endpoint by showing a statistically significant average reduction in sIGF-1 levels from baseline (P<0.0001) at week 14 (one week past the last dose) at the twice weekly 200 mg dose tested. Antisense is currently undertaking a higher dose study (2 x 300 mg/week) in acromegaly patients. Under its technology collaboration with Isis, Antisense Therapeutics’ will pay Isis a percentage (single digit) of the licensing revenue it earns from ATL1103.
Disease: acromegaly
Details:
- • On December 22, 2017, Antisense Therapeutics announced that it has executed a global agreement with innovative early access provider myTomorrows to implement an Early Access Program (EAP) for ATL1103 (atesidorsen), for the treatment of acromegaly. This program will initially be established in selected countries within the European Union.
- Subject to myTomorrows receiving the requisite regulatory approvals and support for the ATL1103 EAP program, Antisense Therapeutics expects to provide ATL1103 to treatment centers in the EU. myTomorrows has undertaken certain product assessments that have included discussions with a number of key acromegaly experts in Europe (including some of the investigators from the ATL1103 Phase II clinical trial) to identify the unmet medical need in the relevant patient group, where myTomorrows received good support for the concept of using ATL1103 in patients not controlled on current acromegaly treatments.
- Antisense Therapeutics currently has sufficient supplies of ATL1103 raw material to potentially treat approximately 15 patients for 1 year. Under the EAP, the company can set pricing for the drug. The next step for Antisense Therapeutics would be to arrange for the ATL1103 raw material to be formulated into injectable product for potential use in the EAP.
- Under the EAP agreement, myTomorrows will perform at their cost the EAP activities including relevant data collection and the seeking of the EAP treatment approvals. myTomorrows is to receive a share of EAP related revenue less associated pass through costs including those to Ionis Pharmaceuticals from whom Antisense Therapeutics in-licensed ATL1103.
- Separate to this EAP agreement, Antisense Therapeutics is seeking a partner for the on-going clinical development and potential commercialisation of ATL1103. In the event of future licensing revenue and sales of ATL1103, myTomorrows will also be entitled to a percentage of such sales and licensing revenue received by Antisense Therapeutics as compensation for the services provided, but only in those countries where an EAP had been established.
Financial terms:
Latest news:
Is general: Yes
