Clinical trials have demonstrated that intermittent apomorphine injections provide rapid and effective relief from sudden, unexpected “off” periods brought on by primary Parkinson’s medicine, levodopa.
Oncotelic Inc
.
, an immuno-oncology company developing RNA therapeutics and small molecule drugs to treat cancers and infectious diseases, is branching out. On Monday, the company
announced
that it had licensed an intranasal apomorphine asset from Autotelic Inc. for the treatment of Parkinson’s disease (PD), Erectile Dysfunction (ED) and Female Sexual Dysfunction (FSD).
The Agoura Hills, CA-based company plans to develop intranasal apomorphine (AL-101) through the fast-to-market 505(b)2 regulatory pathway. Oncotelic is hopeful that intranasal administration of the drug, which, contrary to its name, does not actually contain morphine, will have a unique effect in these high unmet need treatment areas.
Clinical trials have
demonstrated
that intermittent apomorphine injections provide rapid and effective relief from sudden, unexpected “off” periods brought on by primary Parkinson’s medicine, levodopa. In addition, several studies have shown that continuous infusion of the drug reduced daily off time by approximately 50%. Apomorphine, a short-acting dopamine D1 and D2 receptor agonist was the
first
dopamine receptor agonist used to treat Parkinson’s disease. It has been shown to have similar efficacy to levodopa. In ED, the specific focus will be on phosphodiesterase 5 (PDE5) non-responders.
“The acquisition of AL-101 brings in a product with substantially large market potential for existing and unmet medical needs into the Company. With a substantially large number of new patients being diagnosed with PD, PDE5, ED every year and limited therapies available for FSD and HSDD, the Company believes that this acquisition has the potential to transform the Company,” said Saran Saund, Oncotelic’s chief business officer and GM of the AI division in a statement.
The company said that AL-101 had shown a favorable safety and efficacy pro six clinical trials with more than 200 patients treated and added that it is phase III ready.
Oncotelic, which is also developing an Ayurvedic therapeutic for COVID-19 with its Indian partner Windlas Biotech Private Ltd., is no stranger to novel mechanisms of action. ARTIVeda, which is intended for people with potential or confirmed COVID-19 infections, is a formulated plant extract of the indigenous plant Artemisia and works through TGF-β inhibition. According to the company, Artemisinin has proven to be highly potent at inhibiting the ability of SARS-CoV-2 to multiply.
Dr.Vuong Trieu, chief executive officer and chairman of Oncotelic, shared the positioning of the new asset.
“With the acquisition of AL-101, we have positioned the company for its next stage of growth through the fast to market 505(b)2 regulatory pathway more appropriate for a company of our size and history,” Trieu said.
Oncotelic’s pipeline also includes OT-101, a first-in-class anti-TGF-β RNA therapeutic being developed for the treatment of solid tumors with a focus on brain cancer in adults and Diffuse intrinsic pontine glioma (DIPG), a tumor that starts in the brainstem, in children. CA4P, a vascular disrupting agent (VDA) for solid tumors, is being developed with a focus on melanoma. Oxi4503, a second-generation VDA – is being studied for the treatment of liquid tumors, with a focus on childhood leukemia.
