Biomics Centre

Overview:

Biomics Medical Center focuses on designing and developing original solutions that combine its formulation and production abilities with relevant molecules towards the improvement of present day care standards.

Business:

Our proprietary business model was designed to create value for stockholders by offering a novel and comprehensively improved biotech and medical product revenue flow that are backed by a profitable and cost-effective corporate infrastructure. Our aim is to offer investors the chance to become a part of a future success story through a meaningful, diversified and mutually beneficial business relationship with Biomics. Our business model was established by leveraging our strong-points: product discovery, attentive development and continuous product improvement.
At present the contemporary insulin market is comprised in proportion of 50% of basic insulin solutions at more than US $10 Billion, with less than 15% being represented by commercially available insulin treatments that last for more than 24 hours.
Taking note of this aspect a large number of companies validate the need for basic insulin therapies with a duration of more than 24 hours, however all of these therapies are based on complex insulin analogs
Long-acting insulin offers the possibility for an enhanced and upgraded treatment of diabetes; however a number of obstacles currently impede the adequate utilization of insulin:
  1. Patients that are adverse to injections/needles
  2. Risk concerns such as hypoglycemia
  3. Weight gain

 

While somewhat difficult to manage such obstacles are common occurrences for diabetes specialist and can be solved, even more so when the benefits of long-acting insulin are taken into account and compared to the disadvantages:
  1. Reduced blood glucose variability
  2. Reduced risk of hypoglycemia
  3. Reduced weight gain

Our Solution: Afremlin

  • The Goal: Developing a human recombinant insulin formulation that can be delivered in a small volume injection that lasts one week and covers all the requirements of basic insulin
  • The Challenge: Insulin is an infamously complex molecule to formulate
  • The Solution: A uniform biodegradable microsphere with PEGylated human recombinant insulin, which allows solubility and PLGA, which extends the release of insulin
Biomics’ principal product candidate, Afremlin, a recombinant form of human basic insulin designed for one-per-week injection, has the capacity to considerably improve the current treatment procedures for insulin replacement.
Basic insulin is the insulin that is continuously dispensed by the pancreas and regulates the level of sugar in the bloodstream between meals and while we sleep. At present the standard form of diabetes treatment that involves basic insulin is a once-per-day injection. In preclinical trials, Afremlin showed promising results, and if approved can make a powerful impact in the multi-billion basic insulin market, and significantly better the life of diabetics by reducing the number of injections from seven to only one injection per week.

Afremlin Formulation Step 1: PEGylation

  • Using site-specific amine PEGylation, attach a low molecular weight PEG to the N terminus of human insulin’s B peptide chain so that insulin dissolves uniformly in oil or water-based

Afremlin Formulation Step 2: Dissolution

  • PEGylated insulin is co-dissolved with a polymer (poly-lactic co-glycolic acid, or PLGA), in a solvent [oil phase]
  • PLGA is critical for determining the rate at which PEGylated insulin is released into the body by hydrolysis

Afremlin Formulation Step 3: Emulsion

  • Generate an oil-in-water emulsion by passing both the oil and water phases through a packed glass bead bed emulsifier to form uniform microspheres comprised of PEG-insulin and PLGA

Afremlin: in Vitro & in Vivo Pharmacology

In Vitro Characterization of PEGylated Insulin (drug substance):
  1. Displayed an affinity for the IGF-1 receptor that is similar to native insulin, which would suggest a low risk of mitogenicity
  2. Displayed an affinity for the insulin receptor that is similar to native insulin once bound, which predicts insulin activity in humans
  3. Inhibited hepatic glucose production to the same magnitude and with the same potency as native insulin
In Vivo Pharmacokinetics and Pharmacodynamics of Afremlin in three animal species:
  1. Slow onset, sustained insulin increases and corresponding glucose reductions over the course of a week in rats, dogs and diabetic mini-pigs
  2. No acute insulin release or glucose reduction
  3. Supports weekly dosing as a basal insulin formulation
  4. Efficacious doses in animals can be readily translated to human clinically relevant doses that can be administered via acceptable volumes and needle gauge

Afremlin: Clinical Development Plan

  • Completed: Pharmacology and toxicology studies in animal subjects
  • H2 2016: File Investigational New Drug (IND)
  • H1 2017: Single and repeat ascending dose safety and efficacy studies (PK-PD) to establish once-weekly dosing regimen in type 1 and type 2 diabetes patients
  • H2 2017: Compare glycemic efficacy of once weekly dosing regimen to Lantus (standard of care) in type 1 and type 2 diabetes patients

Glucolitol RX

  • Potential once-weekly orally-administered PEGylated GLP-1agonist
  • Therapy has potential to complement glycemic control while attenuating weight gain and hypoglycemic risk
  • Preclinical studies are ongoing
  • The world’s leading diabetes care companies are validating the need for a GLP-1 agonist and basic insulin combination therapy, but their products are targeting daily dosing
In August 2015, Biomics announced that it has included a new successfully developed product candidate in its development pipeline. With the potential of becoming an efficient treatment for type 2 diabetes, Glucolitol RX is an orally administered pill based on a GLP-1 agonist, which has the added advantage of alleviating weight gain and reduces the risk of hypoglycemic episodes. As a once-per-day orally administered therapy, Glucolitol RX would be differentiated from the majority of other diabetes treatments that are undergoing clinical development at present and require day-to-day injections. Biomics is currently undergoing continuous phase 1 clinical trials for Glucolitol RX.

As an alternative biotechnological solution Biomics is also developing an invasive form of diabetes treatment using the Biomics Insulin Organoid (B.I.O), a bioengineered micro-organ that functions similarly to the human pancreas, sensing blood sugar levels and dispensing the right amount of insulin. Based on a novel form of islet transplantation the B.I.O. is currently under development, with researchers and scientists trying to determine the part of the body where the B.I.O. can be placed (currently the area favored for implant would be the omentum) and offers similar conditions to the pancreas for islet survival and development, such as an adequate supply of oxygen, sufficient space and the necessary nutrients required to normalize blood sugar levels.