BPH is a common chronic disease caused by an enlarged prostate. DPI-221 may offer a first-in-class novel approach to the treatment of BPH by acting on the central nervous system to suppress abnormal bladder activity without interfering with normal function. In preclinical studies, DPI-221 was effective at reestablishing neural control of the bladder by allowing coordinated bladder contractions, leading to efficient voiding. In the first-in-human Phase I oral dose escalation study, the drug was well tolerated, and there were no serious adverse events or study dropouts. The PK data have allowed planning of a human urodynamic study to demonstrate efficacy and so inform dosing in a subsequent Phase II clinical study. If successfully developed, this novel medication could prevent the need for BPH surgery.
The third small molecule, which is IND stage, is called DPI-289. It is currently being developed to treat patients suffering from severe Parkinson’s disease. And the Michael J. Fox Foundation has provided about $1.5 million in grant funding to support much of the preclinical work that has been successfully completed. Nearly all Parkinson’s disease patients are initially treated with the gold standard medication called levodopa or L-Dopa. Unfortunately, after a few years of treatment, the duration of effect is markedly curtailed, so-called reduce on time. And almost all patients exhibit severe abnormal movements called levodopa-induced dyskinesia, or LID . LID is very hard to treat and severe LID makes it impossible for the patient to lead a normal life.
Preclinical studies demonstrated DPI-289’s ability to treat Parkinsonian disability in rodent and nonhuman primate models. And in particular, it appears to dramatically increase on time without causing dyskinesia. The next step for this program is to carry out IND-enabling toxicology to allow filing for an IND for the first-in-human studies. The initial goal with this compound is to target Parkinson’s patients late in their disease. These patients often need brain surgeries to allow deep brain stimulation, or DBS, and the goal of DPI-289’s treatment would be to prevent the need for such surgeries and also to make it available to patients who are medically ineligible for DBS. Given this limited target population, we expect to be granted orphan drug status for this molecule from the FDA and other international regulatory agencies.
If orphan drug status is obtained, the cost and duration of clinical development program may be significantly reduced, allowing for approval in an accelerated time frame. Initially, DPI-289 will be developed as monotherapy but future studies will examine its utility in Parkinson’s disease as combination therapy with L-Dopa, a so-called dopa-sparing strategy, that limits the progression of LID. Since the company’s inception, DMK’s development programs have been largely financed by nondilutive funding from the government, including funding from the NIH and the New Jersey Commission on Science, Innovation and Technology. Moving forward in the combined company, I intend to continue to seek additional nondilutive funding from governmental programs and NGOs, with the goal of reducing the amount of fundraising required from capital markets.
Given that our programs have high societal impact, I believe such a nondilutive funding strategy is quite possible. In addition to the DMK portfolio, I will bring to the combined company my expertise in medical affairs and marketing. This experience will allow me to enhance the sales of ZIMHI within the context of the new company that is prominent or will be prominent in the addiction space. In summary, the combination of Adamis and DMK will own a portfolio of compounds with synergy in the opioid use disorder space to prevent death and to treat and prevent the disease. Our array of compounds allows for multiple shots on goal to reduce risk to the overall portfolio. David?
